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OP RSH PRO00037870/PERIOPERATIVE COHORT – NEOADJUVANT PERIOD	

Types:      Research Oncology Treatment
Synonyms:  HIGH-RISK, MUSCLE-INVASIVE UROTHELIAL CARCINOMA POST-RADICAL RESECTION, COHORT, NEOADJUVANT

Cycle 1	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -3/+3 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	For questions or Adverse Event (AE) reporting please contact research coordinator: 
Taliah Muhammad 
P: 3462384523 
E: tnmuhammad@houstonmethodist.org
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, heart rate, respiration rate, and temperature.
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Blood pressure (BP) and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. BP and pulse measurements will be assessed with a completely automated device. Manual techniques will be used only if an automated device is not available.
			Labs
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	·        NOTE: Labs do not need to be repeated if collected <=72 hours prior to a dose.
·        If TSH is abnormal, perform T3 + T4. Total T3 is preferred, if not available free T3 may be tested. Free T4 is permitted when T4 is not available. After Cycle 1, participants may receive assigned study intervention while thyroid function test results are pending.
·	POCBP: Negative pregnancy test is required within 24 hours (urine test) or 72 hours (serum test) before dosing.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	POC GLUCOSE	Interval: --	Occurrences: --		  	RETICULOCYTE COUNT	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Predose samples should be collection within 30 minutes before the start of the infusion and post dose samples within 10 minutes after the end of the infusion.
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Treatment Conditions - Research
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	On days Enfortumab Vedotin is administered:
· HOLD and notify provider if
        o  ANC LESS than 1,000;
        o   Platelets LESS than 100,000;
        o  AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN;
        o  Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
        o  Blood Glucose is GREATER than or EQUAL to 250 mg/dL. 
·   Monitor patient for skin reactions such as maculopapular rash, dryness, redness, itching, skin peeling, and/or painful areas.
·   If HbA1c is elevated (GREATER or EQUAL to 6.5%), notify provider for glucose management.
			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.
			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
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemo.			Chemotherapy
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	·	Start date can be as early as N2D1 or as late as N4D22. 
·	If dose 1 of V940 is on or before N4D1, the last neoadjuvant dose of V940 will be on N4D22. If dose 1 of V940 is after N4D1, participants will receive only 1 neoadjuvant dose of V940 on either N4D8 or N4D15 or N4D22. 
·	Participants will receive the number of doses needed to equal 9 doses TOTAL (Neoadjuvant plus Adjuvant period combined).
		  	INV-V940 1 MG/1 ML (V940-005/PRO00037870/SATKUNASIVAM) INTRAMUSCULAR INJECTION 1 mL	Dose: 1 mL	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Administer intramuscularly into the deltoid, thigh, or gluteus muscles.
Syringe contains V940 for IM injection. Inject 1 mL intramuscularly once into the deltoid muscle.  Alternate arms for different doses of V940. Prepared syringe is stable for 8 hours room temperature.
			Immuno-therapy
  	INV-enfortumab vedotin (V940-005/Pro00037870/Kaushik) 1.25 mg/kg in sodium chloride 0.9% 100 mL infusion	Dose: 1.25 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Rule-Based Template: HM ONCBCN TX MODIFICATION TEMPLATE INV-ENFORTUMAB PRO00037870 1.25 MG/KG	  Conditions:	  Modifications:	  Patient weights less than or equal to 100 kg	  Set dose to 1.25 mg/kg	  Patient weights over 100 kg	  Set dose to 125 mg	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ENFORTUMAB VEDOTIN 30 MG INTRAVENOUS SOLN (V940-005/PRO00037870/KAUSHIK)	Medications	1.25 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes			  	INV-enfortumab vedotin (V940-005/Pro00037870/Kaushik) 1 mg/kg in sodium chloride 0.9% 100 mL infusion	Dose: 1 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Rule-Based Template: HM ONCBCN TX MODIFICATION TEMPLATE INV-ENFORTUMAB PRO00037870 1 MG/KG	  Conditions:	  Modifications:	  Patient weights less than or equal to 100 kg	  Set dose to 1 mg/kg	  Patient weights over 100 kg	  Set dose to 100 mg	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ENFORTUMAB VEDOTIN 30 MG INTRAVENOUS SOLN (V940-005/PRO00037870/KAUSHIK)	Medications	1 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes			  	INV-enfortumab vedotin (V940-005/Pro00037870/Kaushik) 0.75 mg/kg in sodium chloride 0.9% 100 mL infusion	Dose: 0.75 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Rule-Based Template: HM ONCBCN TX MODIFICATION TEMPLATE INV-ENFORTUMAB PRO00037870 0.75 MG/KG	  Conditions:	  Modifications:	  Patient weights less than or equal to 100 kg	  Set dose to 0.75 mg/kg	  Patient weights over 100 kg	  Set dose to 75 mg	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ENFORTUMAB VEDOTIN 30 MG INTRAVENOUS SOLN (V940-005/PRO00037870/KAUSHIK)	Medications	0.75 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Chemotherapy
  	INV-PEMBROLIZUMAB (V940-005/PRO00037870/SATKUNASIVAM) 200 mg in sodium chloride 0.9% 100 mL	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 – 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG INTRAVENOUS SOLUTION (V940-005/PRO00037870/KAUSHIK)	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					Post Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			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			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
				Day 8	Perform every 1 day x1			Research tolerance: -3/+3 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	For questions or Adverse Event (AE) reporting please contact research coordinator: 
Taliah Muhammad 
P: 3462384523 
E: tnmuhammad@houstonmethodist.org
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, heart rate, respiration rate, and temperature.
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Blood pressure (BP) and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. BP and pulse measurements will be assessed with a completely automated device. Manual techniques will be used only if an automated device is not available.
			Labs
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	·        NOTE: Labs do not need to be repeated if collected <=72 hours prior to a dose.
·        If TSH is abnormal, perform T3 + T4. Total T3 is preferred, if not available free T3 may be tested. Free T4 is permitted when T4 is not available. After Cycle 1, participants may receive assigned study intervention while thyroid function test results are pending.
·	POCBP: Negative pregnancy test is required within 24 hours (urine test) or 72 hours (serum test) before dosing.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	POC GLUCOSE	Interval: --	Occurrences: --		  	RETICULOCYTE COUNT	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Treatment Conditions - Research
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	On days Enfortumab Vedotin is administered:
· HOLD and notify provider if
        o  ANC LESS than 1,000;
        o   Platelets LESS than 100,000;
        o  AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN;
        o  Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
        o  Blood Glucose is GREATER than or EQUAL to 250 mg/dL. 
·   Monitor patient for skin reactions such as maculopapular rash, dryness, redness, itching, skin peeling, and/or painful areas.
·   If HbA1c is elevated (GREATER or EQUAL to 6.5%), notify provider for glucose management.
			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.
			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
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemo.			Chemotherapy
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	·	Start date can be as early as N2D1 or as late as N4D22. 
·	If dose 1 of V940 is on or before N4D1, the last neoadjuvant dose of V940 will be on N4D22. If dose 1 of V940 is after N4D1, participants will receive only 1 neoadjuvant dose of V940 on either N4D8 or N4D15 or N4D22. 
·	Participants will receive the number of doses needed to equal 9 doses TOTAL (Neoadjuvant plus Adjuvant period combined).
		  	INV-V940 1 MG/1 ML (V940-005/PRO00037870/SATKUNASIVAM) INTRAMUSCULAR INJECTION 1 mL	Dose: 1 mL	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Administer intramuscularly into the deltoid, thigh, or gluteus muscles.
Syringe contains V940 for IM injection. Inject 1 mL intramuscularly once into the deltoid muscle.  Alternate arms for different doses of V940. Prepared syringe is stable for 8 hours room temperature.
			Immuno-therapy
  	INV-enfortumab vedotin (V940-005/Pro00037870/Kaushik) 1.25 mg/kg in sodium chloride 0.9% 100 mL infusion	Dose: 1.25 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Rule-Based Template: HM ONCBCN TX MODIFICATION TEMPLATE INV-ENFORTUMAB PRO00037870 1.25 MG/KG	  Conditions:	  Modifications:	  Patient weights less than or equal to 100 kg	  Set dose to 1.25 mg/kg	  Patient weights over 100 kg	  Set dose to 125 mg	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ENFORTUMAB VEDOTIN 30 MG INTRAVENOUS SOLN (V940-005/PRO00037870/KAUSHIK)	Medications	1.25 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes			  	INV-enfortumab vedotin (V940-005/Pro00037870/Kaushik) 1 mg/kg in sodium chloride 0.9% 100 mL infusion	Dose: 1 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Rule-Based Template: HM ONCBCN TX MODIFICATION TEMPLATE INV-ENFORTUMAB PRO00037870 1 MG/KG	  Conditions:	  Modifications:	  Patient weights less than or equal to 100 kg	  Set dose to 1 mg/kg	  Patient weights over 100 kg	  Set dose to 100 mg	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ENFORTUMAB VEDOTIN 30 MG INTRAVENOUS SOLN (V940-005/PRO00037870/KAUSHIK)	Medications	1 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes			  	INV-enfortumab vedotin (V940-005/Pro00037870/Kaushik) 0.75 mg/kg in sodium chloride 0.9% 100 mL infusion	Dose: 0.75 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Rule-Based Template: HM ONCBCN TX MODIFICATION TEMPLATE INV-ENFORTUMAB PRO00037870 0.75 MG/KG	  Conditions:	  Modifications:	  Patient weights less than or equal to 100 kg	  Set dose to 0.75 mg/kg	  Patient weights over 100 kg	  Set dose to 75 mg	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ENFORTUMAB VEDOTIN 30 MG INTRAVENOUS SOLN (V940-005/PRO00037870/KAUSHIK)	Medications	0.75 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 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			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
					
Cycle 2	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -3/+3 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	For questions or Adverse Event (AE) reporting please contact research coordinator: 
Taliah Muhammad 
P: 3462384523 
E: tnmuhammad@houstonmethodist.org
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, heart rate, respiration rate, and temperature.
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Blood pressure (BP) and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. BP and pulse measurements will be assessed with a completely automated device. Manual techniques will be used only if an automated device is not available.
			Labs
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	·        NOTE: Labs do not need to be repeated if collected <=72 hours prior to a dose.
·        If TSH is abnormal, perform T3 + T4. Total T3 is preferred, if not available free T3 may be tested. Free T4 is permitted when T4 is not available. After Cycle 1, participants may receive assigned study intervention while thyroid function test results are pending.
·	POCBP: Negative pregnancy test is required within 24 hours (urine test) or 72 hours (serum test) before dosing.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	POC GLUCOSE	Interval: --	Occurrences: --		  	RETICULOCYTE COUNT	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Predose samples should be collection within 30 minutes before the start of the infusion and post dose samples within 10 minutes after the end of the infusion.
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Treatment Conditions - Research
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	On days Enfortumab Vedotin is administered:
· HOLD and notify provider if
        o  ANC LESS than 1,000;
        o   Platelets LESS than 100,000;
        o  AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN;
        o  Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
        o  Blood Glucose is GREATER than or EQUAL to 250 mg/dL. 
·   Monitor patient for skin reactions such as maculopapular rash, dryness, redness, itching, skin peeling, and/or painful areas.
·   If HbA1c is elevated (GREATER or EQUAL to 6.5%), notify provider for glucose management.
			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.
			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
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemo.			Chemotherapy
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	·	Start date can be as early as N2D1 or as late as N4D22. 
·	If dose 1 of V940 is on or before N4D1, the last neoadjuvant dose of V940 will be on N4D22. If dose 1 of V940 is after N4D1, participants will receive only 1 neoadjuvant dose of V940 on either N4D8 or N4D15 or N4D22. 
·	Participants will receive the number of doses needed to equal 9 doses TOTAL (Neoadjuvant plus Adjuvant period combined).
		  	INV-V940 1 MG/1 ML (V940-005/PRO00037870/SATKUNASIVAM) INTRAMUSCULAR INJECTION 1 mL	Dose: 1 mL	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Administer intramuscularly into the deltoid, thigh, or gluteus muscles.
Syringe contains V940 for IM injection. Inject 1 mL intramuscularly once into the deltoid muscle.  Alternate arms for different doses of V940. Prepared syringe is stable for 8 hours room temperature.
			Immuno-therapy
  	INV-enfortumab vedotin (V940-005/Pro00037870/Kaushik) 1.25 mg/kg in sodium chloride 0.9% 100 mL infusion	Dose: 1.25 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Rule-Based Template: HM ONCBCN TX MODIFICATION TEMPLATE INV-ENFORTUMAB PRO00037870 1.25 MG/KG	  Conditions:	  Modifications:	  Patient weights less than or equal to 100 kg	  Set dose to 1.25 mg/kg	  Patient weights over 100 kg	  Set dose to 125 mg	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ENFORTUMAB VEDOTIN 30 MG INTRAVENOUS SOLN (V940-005/PRO00037870/KAUSHIK)	Medications	1.25 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes			  	INV-enfortumab vedotin (V940-005/Pro00037870/Kaushik) 1 mg/kg in sodium chloride 0.9% 100 mL infusion	Dose: 1 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Rule-Based Template: HM ONCBCN TX MODIFICATION TEMPLATE INV-ENFORTUMAB PRO00037870 1 MG/KG	  Conditions:	  Modifications:	  Patient weights less than or equal to 100 kg	  Set dose to 1 mg/kg	  Patient weights over 100 kg	  Set dose to 100 mg	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ENFORTUMAB VEDOTIN 30 MG INTRAVENOUS SOLN (V940-005/PRO00037870/KAUSHIK)	Medications	1 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes			  	INV-enfortumab vedotin (V940-005/Pro00037870/Kaushik) 0.75 mg/kg in sodium chloride 0.9% 100 mL infusion	Dose: 0.75 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Rule-Based Template: HM ONCBCN TX MODIFICATION TEMPLATE INV-ENFORTUMAB PRO00037870 0.75 MG/KG	  Conditions:	  Modifications:	  Patient weights less than or equal to 100 kg	  Set dose to 0.75 mg/kg	  Patient weights over 100 kg	  Set dose to 75 mg	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ENFORTUMAB VEDOTIN 30 MG INTRAVENOUS SOLN (V940-005/PRO00037870/KAUSHIK)	Medications	0.75 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Chemotherapy
  	INV-PEMBROLIZUMAB (V940-005/PRO00037870/SATKUNASIVAM) 200 mg in sodium chloride 0.9% 100 mL	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 – 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG INTRAVENOUS SOLUTION (V940-005/PRO00037870/KAUSHIK)	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			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
				Day 8	Perform every 1 day x1			Research tolerance: -3/+3 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	For questions or Adverse Event (AE) reporting please contact research coordinator: 
Taliah Muhammad 
P: 3462384523 
E: tnmuhammad@houstonmethodist.org
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, heart rate, respiration rate, and temperature.
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Blood pressure (BP) and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. BP and pulse measurements will be assessed with a completely automated device. Manual techniques will be used only if an automated device is not available.
			Labs
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	·        NOTE: Labs do not need to be repeated if collected <=72 hours prior to a dose.
·        If TSH is abnormal, perform T3 + T4. Total T3 is preferred, if not available free T3 may be tested. Free T4 is permitted when T4 is not available. After Cycle 1, participants may receive assigned study intervention while thyroid function test results are pending.
·	POCBP: Negative pregnancy test is required within 24 hours (urine test) or 72 hours (serum test) before dosing.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	POC GLUCOSE	Interval: --	Occurrences: --		  	RETICULOCYTE COUNT	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Treatment Conditions - Research
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	On days Enfortumab Vedotin is administered:
· HOLD and notify provider if
        o  ANC LESS than 1,000;
        o   Platelets LESS than 100,000;
        o  AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN;
        o  Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
        o  Blood Glucose is GREATER than or EQUAL to 250 mg/dL. 
·   Monitor patient for skin reactions such as maculopapular rash, dryness, redness, itching, skin peeling, and/or painful areas.
·   If HbA1c is elevated (GREATER or EQUAL to 6.5%), notify provider for glucose management.
			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.
			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
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemo.			Chemotherapy
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	·	Start date can be as early as N2D1 or as late as N4D22. 
·	If dose 1 of V940 is on or before N4D1, the last neoadjuvant dose of V940 will be on N4D22. If dose 1 of V940 is after N4D1, participants will receive only 1 neoadjuvant dose of V940 on either N4D8 or N4D15 or N4D22. 
·	Participants will receive the number of doses needed to equal 9 doses TOTAL (Neoadjuvant plus Adjuvant period combined).
		  	INV-V940 1 MG/1 ML (V940-005/PRO00037870/SATKUNASIVAM) INTRAMUSCULAR INJECTION 1 mL	Dose: 1 mL	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Administer intramuscularly into the deltoid, thigh, or gluteus muscles.
Syringe contains V940 for IM injection. Inject 1 mL intramuscularly once into the deltoid muscle.  Alternate arms for different doses of V940. Prepared syringe is stable for 8 hours room temperature.
			Immuno-therapy
  	INV-enfortumab vedotin (V940-005/Pro00037870/Kaushik) 1.25 mg/kg in sodium chloride 0.9% 100 mL infusion	Dose: 1.25 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Rule-Based Template: HM ONCBCN TX MODIFICATION TEMPLATE INV-ENFORTUMAB PRO00037870 1.25 MG/KG	  Conditions:	  Modifications:	  Patient weights less than or equal to 100 kg	  Set dose to 1.25 mg/kg	  Patient weights over 100 kg	  Set dose to 125 mg	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ENFORTUMAB VEDOTIN 30 MG INTRAVENOUS SOLN (V940-005/PRO00037870/KAUSHIK)	Medications	1.25 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes			  	INV-enfortumab vedotin (V940-005/Pro00037870/Kaushik) 1 mg/kg in sodium chloride 0.9% 100 mL infusion	Dose: 1 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Rule-Based Template: HM ONCBCN TX MODIFICATION TEMPLATE INV-ENFORTUMAB PRO00037870 1 MG/KG	  Conditions:	  Modifications:	  Patient weights less than or equal to 100 kg	  Set dose to 1 mg/kg	  Patient weights over 100 kg	  Set dose to 100 mg	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ENFORTUMAB VEDOTIN 30 MG INTRAVENOUS SOLN (V940-005/PRO00037870/KAUSHIK)	Medications	1 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes			  	INV-enfortumab vedotin (V940-005/Pro00037870/Kaushik) 0.75 mg/kg in sodium chloride 0.9% 100 mL infusion	Dose: 0.75 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Rule-Based Template: HM ONCBCN TX MODIFICATION TEMPLATE INV-ENFORTUMAB PRO00037870 0.75 MG/KG	  Conditions:	  Modifications:	  Patient weights less than or equal to 100 kg	  Set dose to 0.75 mg/kg	  Patient weights over 100 kg	  Set dose to 75 mg	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ENFORTUMAB VEDOTIN 30 MG INTRAVENOUS SOLN (V940-005/PRO00037870/KAUSHIK)	Medications	0.75 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 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			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
					
Cycle 3	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1			Research tolerance: -3/+7 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	For questions or Adverse Event (AE) reporting please contact research coordinator: 
Taliah Muhammad 
P: 3462384523 
E: tnmuhammad@houstonmethodist.org
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, heart rate, respiration rate, and temperature.
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Blood pressure (BP) and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. BP and pulse measurements will be assessed with a completely automated device. Manual techniques will be used only if an automated device is not available.
			Labs
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	·        NOTE: Labs do not need to be repeated if collected <=72 hours prior to a dose.
·        If TSH is abnormal, perform T3 + T4. Total T3 is preferred, if not available free T3 may be tested. Free T4 is permitted when T4 is not available. After Cycle 1, participants may receive assigned study intervention while thyroid function test results are pending.
·	POCBP: Negative pregnancy test is required within 24 hours (urine test) or 72 hours (serum test) before dosing.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	POC GLUCOSE	Interval: --	Occurrences: --		  	RETICULOCYTE COUNT	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Treatment Conditions - Research
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	On days Enfortumab Vedotin is administered:
· HOLD and notify provider if
        o  ANC LESS than 1,000;
        o   Platelets LESS than 100,000;
        o  AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN;
        o  Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
        o  Blood Glucose is GREATER than or EQUAL to 250 mg/dL. 
·   Monitor patient for skin reactions such as maculopapular rash, dryness, redness, itching, skin peeling, and/or painful areas.
·   If HbA1c is elevated (GREATER or EQUAL to 6.5%), notify provider for glucose management.
			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.
			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
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemo.			Chemotherapy
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	·	Start date can be as early as N2D1 or as late as N4D22. 
·	If dose 1 of V940 is on or before N4D1, the last neoadjuvant dose of V940 will be on N4D22. If dose 1 of V940 is after N4D1, participants will receive only 1 neoadjuvant dose of V940 on either N4D8 or N4D15 or N4D22. 
·	Participants will receive the number of doses needed to equal 9 doses TOTAL (Neoadjuvant plus Adjuvant period combined).
		  	INV-V940 1 MG/1 ML (V940-005/PRO00037870/SATKUNASIVAM) INTRAMUSCULAR INJECTION 1 mL	Dose: 1 mL	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Administer intramuscularly into the deltoid, thigh, or gluteus muscles.
Syringe contains V940 for IM injection. Inject 1 mL intramuscularly once into the deltoid muscle.  Alternate arms for different doses of V940. Prepared syringe is stable for 8 hours room temperature.
			Immuno-therapy
  	INV-enfortumab vedotin (V940-005/Pro00037870/Kaushik) 1.25 mg/kg in sodium chloride 0.9% 100 mL infusion	Dose: 1.25 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Rule-Based Template: HM ONCBCN TX MODIFICATION TEMPLATE INV-ENFORTUMAB PRO00037870 1.25 MG/KG	  Conditions:	  Modifications:	  Patient weights less than or equal to 100 kg	  Set dose to 1.25 mg/kg	  Patient weights over 100 kg	  Set dose to 125 mg	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ENFORTUMAB VEDOTIN 30 MG INTRAVENOUS SOLN (V940-005/PRO00037870/KAUSHIK)	Medications	1.25 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes			  	INV-enfortumab vedotin (V940-005/Pro00037870/Kaushik) 1 mg/kg in sodium chloride 0.9% 100 mL infusion	Dose: 1 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Rule-Based Template: HM ONCBCN TX MODIFICATION TEMPLATE INV-ENFORTUMAB PRO00037870 1 MG/KG	  Conditions:	  Modifications:	  Patient weights less than or equal to 100 kg	  Set dose to 1 mg/kg	  Patient weights over 100 kg	  Set dose to 100 mg	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ENFORTUMAB VEDOTIN 30 MG INTRAVENOUS SOLN (V940-005/PRO00037870/KAUSHIK)	Medications	1 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes			  	INV-enfortumab vedotin (V940-005/Pro00037870/Kaushik) 0.75 mg/kg in sodium chloride 0.9% 100 mL infusion	Dose: 0.75 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Rule-Based Template: HM ONCBCN TX MODIFICATION TEMPLATE INV-ENFORTUMAB PRO00037870 0.75 MG/KG	  Conditions:	  Modifications:	  Patient weights less than or equal to 100 kg	  Set dose to 0.75 mg/kg	  Patient weights over 100 kg	  Set dose to 75 mg	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ENFORTUMAB VEDOTIN 30 MG INTRAVENOUS SOLN (V940-005/PRO00037870/KAUSHIK)	Medications	0.75 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Chemotherapy
  	INV-PEMBROLIZUMAB (V940-005/PRO00037870/SATKUNASIVAM) 200 mg in sodium chloride 0.9% 100 mL	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 – 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG INTRAVENOUS SOLUTION (V940-005/PRO00037870/KAUSHIK)	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			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
				Day 8	Perform every 1 day x1			Research tolerance: -3/+3 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	For questions or Adverse Event (AE) reporting please contact research coordinator: 
Taliah Muhammad 
P: 3462384523 
E: tnmuhammad@houstonmethodist.org
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, heart rate, respiration rate, and temperature.
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Blood pressure (BP) and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. BP and pulse measurements will be assessed with a completely automated device. Manual techniques will be used only if an automated device is not available.
			Labs
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	·        NOTE: Labs do not need to be repeated if collected <=72 hours prior to a dose.
·        If TSH is abnormal, perform T3 + T4. Total T3 is preferred, if not available free T3 may be tested. Free T4 is permitted when T4 is not available. After Cycle 1, participants may receive assigned study intervention while thyroid function test results are pending.
·	POCBP: Negative pregnancy test is required within 24 hours (urine test) or 72 hours (serum test) before dosing.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	POC GLUCOSE	Interval: --	Occurrences: --		  	RETICULOCYTE COUNT	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Treatment Conditions - Research
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	On days Enfortumab Vedotin is administered:
· HOLD and notify provider if
        o  ANC LESS than 1,000;
        o   Platelets LESS than 100,000;
        o  AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN;
        o  Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
        o  Blood Glucose is GREATER than or EQUAL to 250 mg/dL. 
·   Monitor patient for skin reactions such as maculopapular rash, dryness, redness, itching, skin peeling, and/or painful areas.
·   If HbA1c is elevated (GREATER or EQUAL to 6.5%), notify provider for glucose management.
			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.
			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
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemo.			Chemotherapy
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	·	Start date can be as early as N2D1 or as late as N4D22. 
·	If dose 1 of V940 is on or before N4D1, the last neoadjuvant dose of V940 will be on N4D22. If dose 1 of V940 is after N4D1, participants will receive only 1 neoadjuvant dose of V940 on either N4D8 or N4D15 or N4D22. 
·	Participants will receive the number of doses needed to equal 9 doses TOTAL (Neoadjuvant plus Adjuvant period combined).
		  	INV-V940 1 MG/1 ML (V940-005/PRO00037870/SATKUNASIVAM) INTRAMUSCULAR INJECTION 1 mL	Dose: 1 mL	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Administer intramuscularly into the deltoid, thigh, or gluteus muscles.
Syringe contains V940 for IM injection. Inject 1 mL intramuscularly once into the deltoid muscle.  Alternate arms for different doses of V940. Prepared syringe is stable for 8 hours room temperature.
			Immuno-therapy
  	INV-enfortumab vedotin (V940-005/Pro00037870/Kaushik) 1.25 mg/kg in sodium chloride 0.9% 100 mL infusion	Dose: 1.25 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Rule-Based Template: HM ONCBCN TX MODIFICATION TEMPLATE INV-ENFORTUMAB PRO00037870 1.25 MG/KG	  Conditions:	  Modifications:	  Patient weights less than or equal to 100 kg	  Set dose to 1.25 mg/kg	  Patient weights over 100 kg	  Set dose to 125 mg	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ENFORTUMAB VEDOTIN 30 MG INTRAVENOUS SOLN (V940-005/PRO00037870/KAUSHIK)	Medications	1.25 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes			  	INV-enfortumab vedotin (V940-005/Pro00037870/Kaushik) 1 mg/kg in sodium chloride 0.9% 100 mL infusion	Dose: 1 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Rule-Based Template: HM ONCBCN TX MODIFICATION TEMPLATE INV-ENFORTUMAB PRO00037870 1 MG/KG	  Conditions:	  Modifications:	  Patient weights less than or equal to 100 kg	  Set dose to 1 mg/kg	  Patient weights over 100 kg	  Set dose to 100 mg	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ENFORTUMAB VEDOTIN 30 MG INTRAVENOUS SOLN (V940-005/PRO00037870/KAUSHIK)	Medications	1 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes			  	INV-enfortumab vedotin (V940-005/Pro00037870/Kaushik) 0.75 mg/kg in sodium chloride 0.9% 100 mL infusion	Dose: 0.75 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Rule-Based Template: HM ONCBCN TX MODIFICATION TEMPLATE INV-ENFORTUMAB PRO00037870 0.75 MG/KG	  Conditions:	  Modifications:	  Patient weights less than or equal to 100 kg	  Set dose to 0.75 mg/kg	  Patient weights over 100 kg	  Set dose to 75 mg	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ENFORTUMAB VEDOTIN 30 MG INTRAVENOUS SOLN (V940-005/PRO00037870/KAUSHIK)	Medications	0.75 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 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			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
					
Cycle 4	Repeat 1 time	Cycle length: 22 days	Day 1	Perform every 1 day x1			Research tolerance: -3/+7 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	For questions or Adverse Event (AE) reporting please contact research coordinator: 
Taliah Muhammad 
P: 3462384523 
E: tnmuhammad@houstonmethodist.org
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, heart rate, respiration rate, and temperature.
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Blood pressure (BP) and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. BP and pulse measurements will be assessed with a completely automated device. Manual techniques will be used only if an automated device is not available.
			Labs
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	·        NOTE: Labs do not need to be repeated if collected <=72 hours prior to a dose.
·        If TSH is abnormal, perform T3 + T4. Total T3 is preferred, if not available free T3 may be tested. Free T4 is permitted when T4 is not available. After Cycle 1, participants may receive assigned study intervention while thyroid function test results are pending.
·	POCBP: Negative pregnancy test is required within 24 hours (urine test) or 72 hours (serum test) before dosing.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	POC GLUCOSE	Interval: --	Occurrences: --		  	RETICULOCYTE COUNT	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Treatment Conditions - Research
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	On days Enfortumab Vedotin is administered:
· HOLD and notify provider if
        o  ANC LESS than 1,000;
        o   Platelets LESS than 100,000;
        o  AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN;
        o  Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
        o  Blood Glucose is GREATER than or EQUAL to 250 mg/dL. 
·   Monitor patient for skin reactions such as maculopapular rash, dryness, redness, itching, skin peeling, and/or painful areas.
·   If HbA1c is elevated (GREATER or EQUAL to 6.5%), notify provider for glucose management.
			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.
			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
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemo.			Chemotherapy
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	·	Start date can be as early as N2D1 or as late as N4D22. 
·	If dose 1 of V940 is on or before N4D1, the last neoadjuvant dose of V940 will be on N4D22. If dose 1 of V940 is after N4D1, participants will receive only 1 neoadjuvant dose of V940 on either N4D8 or N4D15 or N4D22. 
·	Participants will receive the number of doses needed to equal 9 doses TOTAL (Neoadjuvant plus Adjuvant period combined).
		  	INV-V940 1 MG/1 ML (V940-005/PRO00037870/SATKUNASIVAM) INTRAMUSCULAR INJECTION 1 mL	Dose: 1 mL	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Administer intramuscularly into the deltoid, thigh, or gluteus muscles.
Syringe contains V940 for IM injection. Inject 1 mL intramuscularly once into the deltoid muscle.  Alternate arms for different doses of V940. Prepared syringe is stable for 8 hours room temperature.
			Immuno-therapy
  	INV-enfortumab vedotin (V940-005/Pro00037870/Kaushik) 1.25 mg/kg in sodium chloride 0.9% 100 mL infusion	Dose: 1.25 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Rule-Based Template: HM ONCBCN TX MODIFICATION TEMPLATE INV-ENFORTUMAB PRO00037870 1.25 MG/KG	  Conditions:	  Modifications:	  Patient weights less than or equal to 100 kg	  Set dose to 1.25 mg/kg	  Patient weights over 100 kg	  Set dose to 125 mg	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ENFORTUMAB VEDOTIN 30 MG INTRAVENOUS SOLN (V940-005/PRO00037870/KAUSHIK)	Medications	1.25 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes			  	INV-enfortumab vedotin (V940-005/Pro00037870/Kaushik) 1 mg/kg in sodium chloride 0.9% 100 mL infusion	Dose: 1 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Rule-Based Template: HM ONCBCN TX MODIFICATION TEMPLATE INV-ENFORTUMAB PRO00037870 1 MG/KG	  Conditions:	  Modifications:	  Patient weights less than or equal to 100 kg	  Set dose to 1 mg/kg	  Patient weights over 100 kg	  Set dose to 100 mg	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ENFORTUMAB VEDOTIN 30 MG INTRAVENOUS SOLN (V940-005/PRO00037870/KAUSHIK)	Medications	1 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes			  	INV-enfortumab vedotin (V940-005/Pro00037870/Kaushik) 0.75 mg/kg in sodium chloride 0.9% 100 mL infusion	Dose: 0.75 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Rule-Based Template: HM ONCBCN TX MODIFICATION TEMPLATE INV-ENFORTUMAB PRO00037870 0.75 MG/KG	  Conditions:	  Modifications:	  Patient weights less than or equal to 100 kg	  Set dose to 0.75 mg/kg	  Patient weights over 100 kg	  Set dose to 75 mg	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ENFORTUMAB VEDOTIN 30 MG INTRAVENOUS SOLN (V940-005/PRO00037870/KAUSHIK)	Medications	0.75 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Chemotherapy
  	INV-PEMBROLIZUMAB (V940-005/PRO00037870/SATKUNASIVAM) 200 mg in sodium chloride 0.9% 100 mL	Dose: 200 mg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Prepared dose contains open label active drug pembrolizumab. Administer intravenously using 0.2 – 5 micron filter over approximately 30 minutes (-5/+10 min). Prepared bag is stable for 6 hours at room temperature, 24 hours refrigerated.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PEMBROLIZUMAB 100 MG INTRAVENOUS SOLUTION (V940-005/PRO00037870/KAUSHIK)	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			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
				Day 8	Perform every 1 day x1			Research tolerance: -3/+3 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	For questions or Adverse Event (AE) reporting please contact research coordinator: 
Taliah Muhammad 
P: 3462384523 
E: tnmuhammad@houstonmethodist.org
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, heart rate, respiration rate, and temperature.
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Blood pressure (BP) and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. BP and pulse measurements will be assessed with a completely automated device. Manual techniques will be used only if an automated device is not available.
			Labs
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	·        NOTE: Labs do not need to be repeated if collected <=72 hours prior to a dose.
·        If TSH is abnormal, perform T3 + T4. Total T3 is preferred, if not available free T3 may be tested. Free T4 is permitted when T4 is not available. After Cycle 1, participants may receive assigned study intervention while thyroid function test results are pending.
·	POCBP: Negative pregnancy test is required within 24 hours (urine test) or 72 hours (serum test) before dosing.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	POC GLUCOSE	Interval: --	Occurrences: --		  	RETICULOCYTE COUNT	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Treatment Conditions - Research
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	On days Enfortumab Vedotin is administered:
· HOLD and notify provider if
        o  ANC LESS than 1,000;
        o   Platelets LESS than 100,000;
        o  AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN;
        o  Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
        o  Blood Glucose is GREATER than or EQUAL to 250 mg/dL. 
·   Monitor patient for skin reactions such as maculopapular rash, dryness, redness, itching, skin peeling, and/or painful areas.
·   If HbA1c is elevated (GREATER or EQUAL to 6.5%), notify provider for glucose management.
			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.
			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
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemo.			Chemotherapy
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	·	Start date can be as early as N2D1 or as late as N4D22. 
·	If dose 1 of V940 is on or before N4D1, the last neoadjuvant dose of V940 will be on N4D22. If dose 1 of V940 is after N4D1, participants will receive only 1 neoadjuvant dose of V940 on either N4D8 or N4D15 or N4D22. 
·	Participants will receive the number of doses needed to equal 9 doses TOTAL (Neoadjuvant plus Adjuvant period combined).
		  	INV-V940 1 MG/1 ML (V940-005/PRO00037870/SATKUNASIVAM) INTRAMUSCULAR INJECTION 1 mL	Dose: 1 mL	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Administer intramuscularly into the deltoid, thigh, or gluteus muscles.
Syringe contains V940 for IM injection. Inject 1 mL intramuscularly once into the deltoid muscle.  Alternate arms for different doses of V940. Prepared syringe is stable for 8 hours room temperature.
			Immuno-therapy
  	INV-enfortumab vedotin (V940-005/Pro00037870/Kaushik) 1.25 mg/kg in sodium chloride 0.9% 100 mL infusion	Dose: 1.25 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Rule-Based Template: HM ONCBCN TX MODIFICATION TEMPLATE INV-ENFORTUMAB PRO00037870 1.25 MG/KG	  Conditions:	  Modifications:	  Patient weights less than or equal to 100 kg	  Set dose to 1.25 mg/kg	  Patient weights over 100 kg	  Set dose to 125 mg	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ENFORTUMAB VEDOTIN 30 MG INTRAVENOUS SOLN (V940-005/PRO00037870/KAUSHIK)	Medications	1.25 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes			  	INV-enfortumab vedotin (V940-005/Pro00037870/Kaushik) 1 mg/kg in sodium chloride 0.9% 100 mL infusion	Dose: 1 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Rule-Based Template: HM ONCBCN TX MODIFICATION TEMPLATE INV-ENFORTUMAB PRO00037870 1 MG/KG	  Conditions:	  Modifications:	  Patient weights less than or equal to 100 kg	  Set dose to 1 mg/kg	  Patient weights over 100 kg	  Set dose to 100 mg	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ENFORTUMAB VEDOTIN 30 MG INTRAVENOUS SOLN (V940-005/PRO00037870/KAUSHIK)	Medications	1 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes			  	INV-enfortumab vedotin (V940-005/Pro00037870/Kaushik) 0.75 mg/kg in sodium chloride 0.9% 100 mL infusion	Dose: 0.75 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Rule-Based Template: HM ONCBCN TX MODIFICATION TEMPLATE INV-ENFORTUMAB PRO00037870 0.75 MG/KG	  Conditions:	  Modifications:	  Patient weights less than or equal to 100 kg	  Set dose to 0.75 mg/kg	  Patient weights over 100 kg	  Set dose to 75 mg	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-ENFORTUMAB VEDOTIN 30 MG INTRAVENOUS SOLN (V940-005/PRO00037870/KAUSHIK)	Medications	0.75 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 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			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
				Day 22	Perform every 1 day x1			Research tolerance: -3/+3 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	For questions or Adverse Event (AE) reporting please contact research coordinator: 
Taliah Muhammad 
P: 3462384523 
E: tnmuhammad@houstonmethodist.org
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, heart rate, respiration rate, and temperature.
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Blood pressure (BP) and pulse measurements should be preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. BP and pulse measurements will be assessed with a completely automated device. Manual techniques will be used only if an automated device is not available.
			Treatment Conditions - Research
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	On days Enfortumab Vedotin is administered:
· HOLD and notify provider if
        o  ANC LESS than 1,000;
        o   Platelets LESS than 100,000;
        o  AST or ALT GREATER than 3x ULN or Total Bilirubin GREATER than 1.5x ULN;
        o  Serum creatinine GREATER than 1.5x ULN or 1.5x ABOVE baseline.
        o  Blood Glucose is GREATER than or EQUAL to 250 mg/dL. 
·   Monitor patient for skin reactions such as maculopapular rash, dryness, redness, itching, skin peeling, and/or painful areas.
·   If HbA1c is elevated (GREATER or EQUAL to 6.5%), notify provider for glucose management.
			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.
			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
  	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemo.			Chemotherapy
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	·	Start date can be as early as N2D1 or as late as N4D22. 
·	If dose 1 of V940 is on or before N4D1, the last neoadjuvant dose of V940 will be on N4D22. If dose 1 of V940 is after N4D1, participants will receive only 1 neoadjuvant dose of V940 on either N4D8 or N4D15 or N4D22. 
·	Participants will receive the number of doses needed to equal 9 doses TOTAL (Neoadjuvant plus Adjuvant period combined).
		  	INV-V940 1 MG/1 ML (V940-005/PRO00037870/SATKUNASIVAM) INTRAMUSCULAR INJECTION 1 mL	Dose: 1 mL	Route: intramuscular	once for 1 dose	Start: S			Instructions:	Administer intramuscularly into the deltoid, thigh, or gluteus muscles.
Syringe contains V940 for IM injection. Inject 1 mL intramuscularly once into the deltoid muscle.  Alternate arms for different doses of V940. Prepared syringe is stable for 8 hours room temperature.
			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			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.