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OP RSH PRO00044071 EA8231 PRATH ARM B: SACITUZUMAB (SG) + PEMBROLIZUMAB	

Types:      Research Oncology Treatment
Synonyms:  PRO00044071 EA8231 PRATH, PACLITAXEL

Cycle 1	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Peripheral Blood. One (1) 10mL EDTA tube
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Peripheral Blood. Two (2) 10mL Streck tubes
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Peripheral Blood. One (1) 10mL SST top tube
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Urine
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 3 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated.

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-pembrolizumab (EA8231/Pro00044071/Prath) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 3.5 Hours	Instructions:	Bag contains pembrolizumab. Infuse IV over approximately 30 minutes using a 0.2 micron inline filter. Flush line with normal saline to complete the infusion. Stable 6 hours room temperature or 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLN (EA8231/PRO00044071/PRATH)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Supportive Care
◉	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Apply to intact, nonirritated skin on the back of the arm or abdomen (only use the back of the arm if caregiver is available to monitor On-body injection status).			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 2	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-pembrolizumab (EA8231/Pro00044071/Prath) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 1.5 Hours	Instructions:	Bag contains pembrolizumab. Infuse IV over approximately 30 minutes using a 0.2 micron inline filter. Flush line with normal saline to complete the infusion. Stable 6 hours room temperature or 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLN (EA8231/PRO00044071/PRATH)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Supportive Care
◉	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Apply to intact, nonirritated skin on the back of the arm or abdomen (only use the back of the arm if caregiver is available to monitor On-body injection status).			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 3	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Perform at baseline (after randomization) and repeated every odd cycle (if pembrolizumab therapy continues) and/or as clinically indicated, e.g., if there is clinical suspicion of an adverse event related to the endocrine system
		  	T4, FREE	Interval: --	Occurrences: --	Comments:	Perform at baseline (after randomization) and repeated every odd cycle (if pembrolizumab therapy continues) and/or as clinically indicated, e.g., if there is clinical suspicion of an adverse event related to the endocrine system
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Peripheral Blood. Two (2) 10mL Streck tubes
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Peripheral Blood. One (1) 10mL SST top tube
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Urine
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	CT OR MRI. Chest, abdomen, and pelvis CT scans thereafter will be performed after 6 weeks (+/- 1 week) from C1D1, then every 9 weeks (+/- 1 week) for the first year, and thereafter every 12 weeks (+/- 1 week) while patients are on the protocol treatment and have not progressed. Additional imaging could be done per physician discretion. Use of bone scan or MRI brain as per physician discretion. If bone scan shows disease at baseline, it should be followed with the same frequency as the other imaging scans for assessment
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-pembrolizumab (EA8231/Pro00044071/Prath) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 1.5 Hours	Instructions:	Bag contains pembrolizumab. Infuse IV over approximately 30 minutes using a 0.2 micron inline filter. Flush line with normal saline to complete the infusion. Stable 6 hours room temperature or 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLN (EA8231/PRO00044071/PRATH)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Supportive Care
◉	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Apply to intact, nonirritated skin on the back of the arm or abdomen (only use the back of the arm if caregiver is available to monitor On-body injection status).			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 4	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-pembrolizumab (EA8231/Pro00044071/Prath) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 1.5 Hours	Instructions:	Bag contains pembrolizumab. Infuse IV over approximately 30 minutes using a 0.2 micron inline filter. Flush line with normal saline to complete the infusion. Stable 6 hours room temperature or 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLN (EA8231/PRO00044071/PRATH)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Supportive Care
◉	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Apply to intact, nonirritated skin on the back of the arm or abdomen (only use the back of the arm if caregiver is available to monitor On-body injection status).			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 5	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 107	Interval: --	Occurrences: --	Comments:	Health Related Quality of Life Assessment.FBISI-18, FACIT-Fatigue, EQ-5D-5L. Perform any time after consent, prior to C1D1 of treatment. +/- 2 weeks are allowed at each time point.
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Perform at baseline (after randomization) and repeated every odd cycle (if pembrolizumab therapy continues) and/or as clinically indicated, e.g., if there is clinical suspicion of an adverse event related to the endocrine system
		  	T4, FREE	Interval: --	Occurrences: --	Comments:	Perform at baseline (after randomization) and repeated every odd cycle (if pembrolizumab therapy continues) and/or as clinically indicated, e.g., if there is clinical suspicion of an adverse event related to the endocrine system
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-pembrolizumab (EA8231/Pro00044071/Prath) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 1.5 Hours	Instructions:	Bag contains pembrolizumab. Infuse IV over approximately 30 minutes using a 0.2 micron inline filter. Flush line with normal saline to complete the infusion. Stable 6 hours room temperature or 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLN (EA8231/PRO00044071/PRATH)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Supportive Care
◉	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Apply to intact, nonirritated skin on the back of the arm or abdomen (only use the back of the arm if caregiver is available to monitor On-body injection status).			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 6	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	CT OR MRI. Chest, abdomen, and pelvis CT scans thereafter will be performed after 6 weeks (+/- 1 week) from C1D1, then every 9 weeks (+/- 1 week) for the first year, and thereafter every 12 weeks (+/- 1 week) while patients are on the protocol treatment and have not progressed. Additional imaging could be done per physician discretion. Use of bone scan or MRI brain as per physician discretion. If bone scan shows disease at baseline, it should be followed with the same frequency as the other imaging scans for assessment
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-pembrolizumab (EA8231/Pro00044071/Prath) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 1.5 Hours	Instructions:	Bag contains pembrolizumab. Infuse IV over approximately 30 minutes using a 0.2 micron inline filter. Flush line with normal saline to complete the infusion. Stable 6 hours room temperature or 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLN (EA8231/PRO00044071/PRATH)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Supportive Care
◉	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Apply to intact, nonirritated skin on the back of the arm or abdomen (only use the back of the arm if caregiver is available to monitor On-body injection status).			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 7	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Perform at baseline (after randomization) and repeated every odd cycle (if pembrolizumab therapy continues) and/or as clinically indicated, e.g., if there is clinical suspicion of an adverse event related to the endocrine system
		  	T4, FREE	Interval: --	Occurrences: --	Comments:	Perform at baseline (after randomization) and repeated every odd cycle (if pembrolizumab therapy continues) and/or as clinically indicated, e.g., if there is clinical suspicion of an adverse event related to the endocrine system
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-pembrolizumab (EA8231/Pro00044071/Prath) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 1.5 Hours	Instructions:	Bag contains pembrolizumab. Infuse IV over approximately 30 minutes using a 0.2 micron inline filter. Flush line with normal saline to complete the infusion. Stable 6 hours room temperature or 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLN (EA8231/PRO00044071/PRATH)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Supportive Care
◉	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Apply to intact, nonirritated skin on the back of the arm or abdomen (only use the back of the arm if caregiver is available to monitor On-body injection status).			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 8	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-pembrolizumab (EA8231/Pro00044071/Prath) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 1.5 Hours	Instructions:	Bag contains pembrolizumab. Infuse IV over approximately 30 minutes using a 0.2 micron inline filter. Flush line with normal saline to complete the infusion. Stable 6 hours room temperature or 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLN (EA8231/PRO00044071/PRATH)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Supportive Care
◉	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Apply to intact, nonirritated skin on the back of the arm or abdomen (only use the back of the arm if caregiver is available to monitor On-body injection status).			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 9	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 107	Interval: --	Occurrences: --	Comments:	Health Related Quality of Life Assessment.FBISI-18, FACIT-Fatigue, EQ-5D-5L. Perform any time after consent, prior to C1D1 of treatment. +/- 2 weeks are allowed at each time point.
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Perform at baseline (after randomization) and repeated every odd cycle (if pembrolizumab therapy continues) and/or as clinically indicated, e.g., if there is clinical suspicion of an adverse event related to the endocrine system
		  	T4, FREE	Interval: --	Occurrences: --	Comments:	Perform at baseline (after randomization) and repeated every odd cycle (if pembrolizumab therapy continues) and/or as clinically indicated, e.g., if there is clinical suspicion of an adverse event related to the endocrine system
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	CT OR MRI. Chest, abdomen, and pelvis CT scans thereafter will be performed after 6 weeks (+/- 1 week) from C1D1, then every 9 weeks (+/- 1 week) for the first year, and thereafter every 12 weeks (+/- 1 week) while patients are on the protocol treatment and have not progressed. Additional imaging could be done per physician discretion. Use of bone scan or MRI brain as per physician discretion. If bone scan shows disease at baseline, it should be followed with the same frequency as the other imaging scans for assessment
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-pembrolizumab (EA8231/Pro00044071/Prath) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 1.5 Hours	Instructions:	Bag contains pembrolizumab. Infuse IV over approximately 30 minutes using a 0.2 micron inline filter. Flush line with normal saline to complete the infusion. Stable 6 hours room temperature or 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLN (EA8231/PRO00044071/PRATH)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Supportive Care
◉	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Apply to intact, nonirritated skin on the back of the arm or abdomen (only use the back of the arm if caregiver is available to monitor On-body injection status).			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 10	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-pembrolizumab (EA8231/Pro00044071/Prath) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 1.5 Hours	Instructions:	Bag contains pembrolizumab. Infuse IV over approximately 30 minutes using a 0.2 micron inline filter. Flush line with normal saline to complete the infusion. Stable 6 hours room temperature or 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLN (EA8231/PRO00044071/PRATH)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 11	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Perform at baseline (after randomization) and repeated every odd cycle (if pembrolizumab therapy continues) and/or as clinically indicated, e.g., if there is clinical suspicion of an adverse event related to the endocrine system
		  	T4, FREE	Interval: --	Occurrences: --	Comments:	Perform at baseline (after randomization) and repeated every odd cycle (if pembrolizumab therapy continues) and/or as clinically indicated, e.g., if there is clinical suspicion of an adverse event related to the endocrine system
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-pembrolizumab (EA8231/Pro00044071/Prath) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 1.5 Hours	Instructions:	Bag contains pembrolizumab. Infuse IV over approximately 30 minutes using a 0.2 micron inline filter. Flush line with normal saline to complete the infusion. Stable 6 hours room temperature or 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLN (EA8231/PRO00044071/PRATH)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Supportive Care
◉	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Apply to intact, nonirritated skin on the back of the arm or abdomen (only use the back of the arm if caregiver is available to monitor On-body injection status).			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 12	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	CT OR MRI. Chest, abdomen, and pelvis CT scans thereafter will be performed after 6 weeks (+/- 1 week) from C1D1, then every 9 weeks (+/- 1 week) for the first year, and thereafter every 12 weeks (+/- 1 week) while patients are on the protocol treatment and have not progressed. Additional imaging could be done per physician discretion. Use of bone scan or MRI brain as per physician discretion. If bone scan shows disease at baseline, it should be followed with the same frequency as the other imaging scans for assessment
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-pembrolizumab (EA8231/Pro00044071/Prath) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 1.5 Hours	Instructions:	Bag contains pembrolizumab. Infuse IV over approximately 30 minutes using a 0.2 micron inline filter. Flush line with normal saline to complete the infusion. Stable 6 hours room temperature or 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLN (EA8231/PRO00044071/PRATH)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Supportive Care
◉	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Apply to intact, nonirritated skin on the back of the arm or abdomen (only use the back of the arm if caregiver is available to monitor On-body injection status).			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 13	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Perform at baseline (after randomization) and repeated every odd cycle (if pembrolizumab therapy continues) and/or as clinically indicated, e.g., if there is clinical suspicion of an adverse event related to the endocrine system
		  	T4, FREE	Interval: --	Occurrences: --	Comments:	Perform at baseline (after randomization) and repeated every odd cycle (if pembrolizumab therapy continues) and/or as clinically indicated, e.g., if there is clinical suspicion of an adverse event related to the endocrine system
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-pembrolizumab (EA8231/Pro00044071/Prath) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 1.5 Hours	Instructions:	Bag contains pembrolizumab. Infuse IV over approximately 30 minutes using a 0.2 micron inline filter. Flush line with normal saline to complete the infusion. Stable 6 hours room temperature or 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLN (EA8231/PRO00044071/PRATH)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Supportive Care
◉	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Apply to intact, nonirritated skin on the back of the arm or abdomen (only use the back of the arm if caregiver is available to monitor On-body injection status).			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 14	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-pembrolizumab (EA8231/Pro00044071/Prath) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 1.5 Hours	Instructions:	Bag contains pembrolizumab. Infuse IV over approximately 30 minutes using a 0.2 micron inline filter. Flush line with normal saline to complete the infusion. Stable 6 hours room temperature or 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLN (EA8231/PRO00044071/PRATH)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Supportive Care
◉	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Apply to intact, nonirritated skin on the back of the arm or abdomen (only use the back of the arm if caregiver is available to monitor On-body injection status).			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 15	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	Perform at baseline (after randomization) and repeated every odd cycle (if pembrolizumab therapy continues) and/or as clinically indicated, e.g., if there is clinical suspicion of an adverse event related to the endocrine system
		  	T4, FREE	Interval: --	Occurrences: --	Comments:	Perform at baseline (after randomization) and repeated every odd cycle (if pembrolizumab therapy continues) and/or as clinically indicated, e.g., if there is clinical suspicion of an adverse event related to the endocrine system
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	CT OR MRI. Chest, abdomen, and pelvis CT scans thereafter will be performed after 6 weeks (+/- 1 week) from C1D1, then every 9 weeks (+/- 1 week) for the first year, and thereafter every 12 weeks (+/- 1 week) while patients are on the protocol treatment and have not progressed. Additional imaging could be done per physician discretion. Use of bone scan or MRI brain as per physician discretion. If bone scan shows disease at baseline, it should be followed with the same frequency as the other imaging scans for assessment
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-pembrolizumab (EA8231/Pro00044071/Prath) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 1.5 Hours	Instructions:	Bag contains pembrolizumab. Infuse IV over approximately 30 minutes using a 0.2 micron inline filter. Flush line with normal saline to complete the infusion. Stable 6 hours room temperature or 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLN (EA8231/PRO00044071/PRATH)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Supportive Care
◉	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Apply to intact, nonirritated skin on the back of the arm or abdomen (only use the back of the arm if caregiver is available to monitor On-body injection status).			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 16	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-pembrolizumab (EA8231/Pro00044071/Prath) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 1.5 Hours	Instructions:	Bag contains pembrolizumab. Infuse IV over approximately 30 minutes using a 0.2 micron inline filter. Flush line with normal saline to complete the infusion. Stable 6 hours room temperature or 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLN (EA8231/PRO00044071/PRATH)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Supportive Care
◉	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Apply to intact, nonirritated skin on the back of the arm or abdomen (only use the back of the arm if caregiver is available to monitor On-body injection status).			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 17	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 107	Interval: --	Occurrences: --	Comments:	Health Related Quality of Life Assessment.FBISI-18, FACIT-Fatigue, EQ-5D-5L. Perform any time after consent, prior to C1D1 of treatment. +/- 2 weeks are allowed at each time point.
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-pembrolizumab (EA8231/Pro00044071/Prath) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 1.5 Hours	Instructions:	Bag contains pembrolizumab. Infuse IV over approximately 30 minutes using a 0.2 micron inline filter. Flush line with normal saline to complete the infusion. Stable 6 hours room temperature or 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLN (EA8231/PRO00044071/PRATH)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Supportive Care
◉	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Apply to intact, nonirritated skin on the back of the arm or abdomen (only use the back of the arm if caregiver is available to monitor On-body injection status).			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 18	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-pembrolizumab (EA8231/Pro00044071/Prath) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 1.5 Hours	Instructions:	Bag contains pembrolizumab. Infuse IV over approximately 30 minutes using a 0.2 micron inline filter. Flush line with normal saline to complete the infusion. Stable 6 hours room temperature or 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLN (EA8231/PRO00044071/PRATH)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Supportive Care
◉	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Apply to intact, nonirritated skin on the back of the arm or abdomen (only use the back of the arm if caregiver is available to monitor On-body injection status).			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 19	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-pembrolizumab (EA8231/Pro00044071/Prath) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 1.5 Hours	Instructions:	Bag contains pembrolizumab. Infuse IV over approximately 30 minutes using a 0.2 micron inline filter. Flush line with normal saline to complete the infusion. Stable 6 hours room temperature or 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLN (EA8231/PRO00044071/PRATH)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Supportive Care
◉	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Apply to intact, nonirritated skin on the back of the arm or abdomen (only use the back of the arm if caregiver is available to monitor On-body injection status).			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 20	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-pembrolizumab (EA8231/Pro00044071/Prath) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 1.5 Hours	Instructions:	Bag contains pembrolizumab. Infuse IV over approximately 30 minutes using a 0.2 micron inline filter. Flush line with normal saline to complete the infusion. Stable 6 hours room temperature or 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLN (EA8231/PRO00044071/PRATH)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Supportive Care
◉	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Apply to intact, nonirritated skin on the back of the arm or abdomen (only use the back of the arm if caregiver is available to monitor On-body injection status).			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 21	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-pembrolizumab (EA8231/Pro00044071/Prath) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 1.5 Hours	Instructions:	Bag contains pembrolizumab. Infuse IV over approximately 30 minutes using a 0.2 micron inline filter. Flush line with normal saline to complete the infusion. Stable 6 hours room temperature or 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLN (EA8231/PRO00044071/PRATH)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Supportive Care
◉	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Apply to intact, nonirritated skin on the back of the arm or abdomen (only use the back of the arm if caregiver is available to monitor On-body injection status).			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 22	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-pembrolizumab (EA8231/Pro00044071/Prath) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 1.5 Hours	Instructions:	Bag contains pembrolizumab. Infuse IV over approximately 30 minutes using a 0.2 micron inline filter. Flush line with normal saline to complete the infusion. Stable 6 hours room temperature or 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLN (EA8231/PRO00044071/PRATH)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Supportive Care
◉	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Apply to intact, nonirritated skin on the back of the arm or abdomen (only use the back of the arm if caregiver is available to monitor On-body injection status).			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 23	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-pembrolizumab (EA8231/Pro00044071/Prath) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 1.5 Hours	Instructions:	Bag contains pembrolizumab. Infuse IV over approximately 30 minutes using a 0.2 micron inline filter. Flush line with normal saline to complete the infusion. Stable 6 hours room temperature or 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLN (EA8231/PRO00044071/PRATH)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Supportive Care
◉	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Apply to intact, nonirritated skin on the back of the arm or abdomen (only use the back of the arm if caregiver is available to monitor On-body injection status).			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
Cycle 24	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Chemotherapy
  	INV-pembrolizumab (EA8231/Pro00044071/Prath) 200 mg in sodium chloride 0.9% 100 mL IVPB	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 1.5 Hours	Instructions:	Bag contains pembrolizumab. Infuse IV over approximately 30 minutes using a 0.2 micron inline filter. Flush line with normal saline to complete the infusion. Stable 6 hours room temperature or 24 hours refrigerated. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 25 MG/ML INTRAVENOUS SOLN (EA8231/PRO00044071/PRATH)	Medications	200 mg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	92 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 8	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION 69	Interval: --	Occurrences: --	Comments:	Ensure TSH, Free T4 and T3 are assessed at least every 6 weeks
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Labs on Day 8 are per physician discretion OR as clinically indicated
			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

Dosing is based on lab value.
o Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP. 
o Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO. 
o Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO. 
o Serum potassium 3.5 mEq/L or greater, do not give potassium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
		  	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Magnesium level LESS than 1.6 mg/dL; 
3. Recent pre-infusion labs. 

Dosing is based on lab value. 
o Serum Magnesium less than 1.0 mg/dL, give 2 gram magnesium sulfate IV and contact MD/NP. 
o Serum Magnesium 1.0 to 1.2 mg/dL, give 2 gram magnesium sulfate IV. 
o Serum Magnesium 1.3 to 1.5 mg/dL, give 1 gram magnesium sulfate IV. 
o Serum Magnesium 1.6 mg/dL or greater, do not give magnesium replacement. 

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1500 or platelets LESS than 100,000
TSH GREATAER than 10 and free T4 LESS than 0.9 or T3 LESS than 80
TSH LESS than 0.27 AND free T4 GREATER than 1.7 or T3 GREATER than 200
AST/ALT GREATER than or EQUAL to 3x ULN or Tbili GREATER than 1.5x ULN
Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: --	Occurrences: --		  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 
		  	dexAMETHasone (DECADRON) IV 12 mg	Dose: 12 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before chemotherapy 		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30-60 minutes before the start of chemotherapy		  	atropine injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once PRN	Start: S				  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S					Chemotherapy
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan is dosed using the patient's actual body weight in kilograms. Doses should be re-calculated for weight changes >10 % during treatment.
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Sacituzumab govitecan followed by pembrolizumab
			Chemotherapy
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	If cycle 1 dose of Sacituzumab govitean-hziy is well tolerated, the cycle 2+ pembrolizumab infusions may be started with no mandatory 30-minute observation period. Patient should still be monitored appropriately during the pembrolizumab infusion, with emergency medications available as needed
			Chemotherapy
  	INV-Sacituzumab govitecan in sodium chloride 0.9% Infusion (EA8231/Pro00044071/Prath) 10 mg/kg (Treatment Plan)	Dose: 10 mg/kg	Route: intravenous	once over 1 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Bag contains sacituzumab govitecan. Infuse IV over 3 hours for the first infusion, and over 1-2 hours for subsequent infusions if well tolerated. Stable 8 hours at room temperature or 24 hours refrigerated. 

Protect the infusion bag from light throughout the process and until the infusion is complete. It is not necessary to cover the infusion tubing. 

HAZARDOUS - Handle with care
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Supportive Care
◉	pegfilgrastim (NEULASTA) on-body injection kit 6 mg	Dose: 6 mg	Route: subcutaneous	once for 1 dose	Start: S			Instructions:	Apply to intact, nonirritated skin on the back of the arm or abdomen (only use the back of the arm if caregiver is available to monitor On-body injection status).			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled					
End of Treatment (EOT)	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 109	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Peripheral Blood. Two (2) 10mL Streck tubes
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Peripheral Blood. One (1) 10mL SST top tube
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Urine
					
Post treatment: Every 3 months if LESS THAN 2 years from the time of randomization and every 6 months from years 2-5	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION 74	Interval: --	Occurrences: --	Comments:	Survival status.It could be obtained from medical record or by telephone. Both disease assessments and the occurrence of any non-protocol anticancer therapy must be documented until progression and obtained according to the same schedule.