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IP/OP RESEARCH PRO00035531 / GANGULY TNB383B.0001 PHASE I ARM E	

Types:      Research Oncology Treatment
Synonyms:  TNB-383B, BCMA

IP and OP Cycle 1	Repeat 1 time	Cycle length: 28 days	IP Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: Until discontinued	Occurrences: --	Comments:	Symptom Directed Physical Exam
		  	ONC NURSING COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 6	Interval: Until discontinued	Occurrences: --	Comments:	Assess Adverse Events and Concomitant Medications/Therapy
		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --	Comments:	Diastolic and systolic blood pressure, heart rate, respiratory rate, and temperature:
·        Pre-dose (up to 10 minutes)
·        30 minutes after start of infusion (+/- 10 minutes)
·        End of infusion (+/- 10 minutes)
·        One hour after end of infusion (+/- 10 minutes)
·        3 hours after end of infusion (+/- 10 minutes)
·        6 hours after end of infusion (+/- 10 minutes)
·        9 hours after end of infusion (+/- 10 minutes)
		  	PULSE OXIMETRY	Interval: Daily	Occurrences: --	Comments:	As clinically indicated:
·        Pre-dose (up to 10 minutes)
·        30 minutes after start of infusion (+/- 10 minutes)
·        End of infusion (+/- 10 minutes)
·        One hour after end of infusion (+/- 10 minutes)
·        3 hours after end of infusion (+/- 10 minutes)
·        6 hours after end of infusion (+/- 10 minutes)
·        9 hours after end of infusion (+/- 10 minutes)
			Line Care
  	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.			Treatment Conditions
  	TREATMENT CONDITIONS	Interval: Until discontinued	Occurrences: --	Comments:	If no infusion-related reactions occur during a cycle of TNB-383B, the investigator may consider shortening the duration of infusion for subsequent cycles to a minimum of 30 minutes.  If a subject experiences a grade 2 infusion reaction, the infusion should be stopped, and the reaction managed according to institutional guidelines. Once the reaction resolves to grade LESS than or EQUAL 1, the infusion may be restarted at half of the infusion rate at which the infusion reaction occurred (e.g. decrease to 62.5 mL/hr from 125 mL/hr, to complete over 4 hours [+/- 20 minutes]).
			Labs
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Any lab test value outside the reference range that the investigator considers to be clinically significant must be repeated, followed until satisfactory resolution.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		  	GGT	Interval: Once	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: Once	Occurrences: --	Comments:	Required for women of childbearing potential.
		  	HCG QUALITATIVE, URINE SCREEN	Interval: Once	Occurrences: --	Comments:	Required for women of childbearing potential.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --			Pre-Medications
  	dexamethasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Can be tapered with subsequent cycles as follows (see protocol pg.74-75): if a subject does not experience an infusion-related reaction (IRR) or an IMT (e.g., CRS or neurological toxicity [NT]) in a given cycle, the dexamethasone premedication dose may be reduced to 10 mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 10 mg dexamethasone IV as premedication, dexamethasone may subsequently be reduced to 5mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 5 mg dexamethasone IV as premedication, dexamethasone may subsequently be omitted from the premedication regimen.		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Or equivalent (ex. Cetirizine 10 mg PO x 1).		  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	every 6 hours	Start: S			Instructions:	Starting from 30 minutes prior to infusion for the first 24 hours.  After Cycle 1 Day 1, for subsequent cycles, Acetaminophen 650-1000mg PO/IV should be administered 30 minutes prior to infusion.			Chemotherapy
  	INV-TNB-383B (TNB383B.0001/Pro00035531/Ganguly) 60 mg, Stabilizer 20 mL in sodium chloride 0.9% 250 mL IVPB	Dose: 60 mg	Route: intravenous	once PRN over 120 Minutes			Offset: 30 Minutes	Instructions:	Administer over 2 hours (+/- 10 mins).
Prepared IV bag contains TNB-383B. Administer intravenously using 0.2-micron sterile inline filter over 120 minutes for initial infusion, then over 60 minutes for subsequent infusions. After the infusion, flush by adding 25 mL of 0.9% NaCl to the IV bag to ensure all drug is infused. Prepared bag is stable for 6 hours at room temperature from start of preparation until the end of the infusion. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TNB-383B 2 MG/ML INTRAVENOUS SOLN (TNB383B.0001/PRO00035531/GANGULY)	Medications	60 mg	Yes	Yes	INV-TNB-383B STABILIZER SOLN (TNB383B.0001/PRO00035531/GANGULY)	Medications	20 mL	Always	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	200 mL	Yes	Yes				Emergency Medications
  	tocilizumab (ACTEMRA) infusion (RESTRICTED) 8 mg/kg (Treatment Plan)	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	At the discretion of the investigator or per institutional guidance.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: Until discontinued	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 83	Interval: Until discontinued	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 4	Interval: Until discontinued	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.
		  	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	Start: S				  	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
  	ONC NURSING COMMUNICATION 76	Interval: Until discontinued	Occurrences: --	Comments:	Discontinue IV.
				IP Day 2	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: Until discontinued	Occurrences: --	Comments:	Discharge from inpatient stay.
		  	ONC NURSING COMMUNICATION 2	Interval: Until discontinued	Occurrences: --	Comments:	Symptom Directed Physical Exam
		  	ONC NURSING COMMUNICATION 6	Interval: Until discontinued	Occurrences: --	Comments:	Assess Adverse Events and Concomitant Medications/Therapy
		  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --	Comments:	Diastolic and systolic blood pressure, heart rate, respiratory rate, and temperature.
		  	PULSE OXIMETRY	Interval: Daily	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Any lab test value outside the reference range that the investigator considers to be clinically significant must be repeated, followed until satisfactory resolution.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		  	GGT	Interval: Once	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --				OP Day 3	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Symptom Directed Physical Exam
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Assess Adverse Events and Concomitant Medications/Therapy
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Diastolic and systolic blood pressure, heart rate, respiratory rate, and temperature.
		  	RESEARCH -  PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Any lab test value outside the reference range that the investigator considers to be clinically significant must be repeated, followed until satisfactory resolution.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --				OP Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Symptom Directed Physical Exam
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Assess Adverse Events and Concomitant Medications/Therapy
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Diastolic and systolic blood pressure, heart rate, respiratory rate, and temperature.
		  	RESEARCH -  PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Any lab test value outside the reference range that the investigator considers to be clinically significant must be repeated, followed until satisfactory resolution.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				OP Day 15	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Symptom Directed Physical Exam
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Assess Adverse Events and Concomitant Medications/Therapy
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Diastolic and systolic blood pressure, heart rate, respiratory rate, and temperature.
		  	RESEARCH -  PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Labs
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Any lab test value outside the reference range that the investigator considers to be clinically significant must be repeated, followed until satisfactory resolution.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				OP Day 22	Perform every 1 day x1		Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
OP Cycle 2	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Symptom Directed Physical Exam
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Assess Adverse Events and Concomitant Medications/Therapy
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Diastolic and systolic blood pressure, heart rate, respiratory rate, and temperature:
·        Pre-dose (up to 10 minutes)
·        30 minutes after start of infusion (+/- 10 minutes)
·        End of infusion (+/- 10 minutes)
·        One hour after end of infusion (+/- 10 minutes)
		  	RESEARCH -  PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	As clinically indicated:
·        Pre-dose (up to 10 minutes)
·        30 minutes after start of infusion (+/- 10 minutes)
·        End of infusion (+/- 10 minutes)
·        One hour after end of infusion (+/- 10 minutes)
			Line Care
  	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.			Treatment Conditions
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	If no infusion-related reactions occur during a cycle of TNB-383B, the investigator may consider shortening the duration of infusion for subsequent cycles to a minimum of 30 minutes.  If a subject experiences a grade 2 infusion reaction, the infusion should be stopped, and the reaction managed according to institutional guidelines. Once the reaction resolves to grade LESS than or EQUAL 1, the infusion may be restarted at half of the infusion rate at which the infusion reaction occurred (e.g. decrease to 62.5 mL/hr from 125 mL/hr, to complete over 4 hours [+/- 20 minutes]).
			Labs
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Any lab test value outside the reference range that the investigator considers to be clinically significant must be repeated, followed until satisfactory resolution.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Required for women of childbearing potential.
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Required for women of childbearing potential.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Pre-Medications
◯	dexamethasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Can be tapered with subsequent cycles as follows (see protocol pg.74-75): if a subject does not experience an infusion-related reaction (IRR) or an IMT (e.g., CRS or neurological toxicity [NT]) in a given cycle, the dexamethasone premedication dose may be reduced to 10 mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 10 mg dexamethasone IV as premedication, dexamethasone may subsequently be reduced to 5mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 5 mg dexamethasone IV as premedication, dexamethasone may subsequently be omitted from the premedication regimen.		◉	dexamethasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Can be tapered with subsequent cycles as follows (see protocol pg.74-75): if a subject does not experience an infusion-related reaction (IRR) or an IMT (e.g., CRS or neurological toxicity [NT]) in a given cycle, the dexamethasone premedication dose may be reduced to 10 mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 10 mg dexamethasone IV as premedication, dexamethasone may subsequently be reduced to 5mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 5 mg dexamethasone IV as premedication, dexamethasone may subsequently be omitted from the premedication regimen.		◯	dexamethasone (DECADRON) IV 5 mg	Dose: 5 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Can be tapered with subsequent cycles as follows (see protocol pg.74-75): if a subject does not experience an infusion-related reaction (IRR) or an IMT (e.g., CRS or neurological toxicity [NT]) in a given cycle, the dexamethasone premedication dose may be reduced to 10 mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 10 mg dexamethasone IV as premedication, dexamethasone may subsequently be reduced to 5mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 5 mg dexamethasone IV as premedication, dexamethasone may subsequently be omitted from the premedication regimen.			Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Or equivalent (ex. Cetirizine 10 mg PO x 1).		  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Or IV; Administer 30 minutes prior to infusion.		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Or 1,000 mg; Administer 30 minutes prior to infusion.			Chemotherapy
  	INV-TNB-383B (TNB383B.0001/Pro00035531/Ganguly) 60 mg, Stabilizer 20 mL in sodium chloride 0.9% 250 mL IVPB	Dose: 60 mg	Route: intravenous	once PRN over 60 Minutes			Offset: 30 Minutes	Instructions:	Administer over 1 hour (+/- 10 mins) if no infusion reaction was experienced in previous cycle.
Prepared IV bag contains TNB-383B. Administer intravenously using 0.2-micron sterile inline filter over 120 minutes for initial infusion, then over 60 minutes for subsequent infusions. After the infusion, flush by adding 25 mL of 0.9% NaCl to the IV bag to ensure all drug is infused. Prepared bag is stable for 6 hours at room temperature from start of preparation until the end of the infusion. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TNB-383B 2 MG/ML INTRAVENOUS SOLN (TNB383B.0001/PRO00035531/GANGULY)	Medications	60 mg	Yes	Yes	INV-TNB-383B STABILIZER SOLN (TNB383B.0001/PRO00035531/GANGULY)	Medications	20 mL	Always	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	200 mL	Yes	Yes				Emergency Medications
  	tocilizumab (ACTEMRA) infusion (RESTRICTED) 8 mg/kg (Treatment Plan)	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	At the discretion of the investigator or per institutional guidance.			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.
		  	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 15	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Symptom Directed Physical Exam
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Assess Adverse Events and Concomitant Medications/Therapy
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Diastolic and systolic blood pressure, heart rate, respiratory rate, and temperature.
		  	RESEARCH -  PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
					
OP Cycle 3	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Symptom Directed Physical Exam
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Assess Adverse Events and Concomitant Medications/Therapy
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Diastolic and systolic blood pressure, heart rate, respiratory rate, and temperature:
·        Pre-dose (up to 10 minutes)
·        30 minutes after start of infusion (+/- 10 minutes)
·        End of infusion (+/- 10 minutes)
·        One hour after end of infusion (+/- 10 minutes)
		  	RESEARCH -  PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	As clinically indicated:
·        Pre-dose (up to 10 minutes)
·        30 minutes after start of infusion (+/- 10 minutes)
·        End of infusion (+/- 10 minutes)
·        One hour after end of infusion (+/- 10 minutes)
			Line Care
  	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.			Treatment Conditions
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	If no infusion-related reactions occur during a cycle of TNB-383B, the investigator may consider shortening the duration of infusion for subsequent cycles to a minimum of 30 minutes.  If a subject experiences a grade 2 infusion reaction, the infusion should be stopped, and the reaction managed according to institutional guidelines. Once the reaction resolves to grade LESS than or EQUAL 1, the infusion may be restarted at half of the infusion rate at which the infusion reaction occurred (e.g. decrease to 62.5 mL/hr from 125 mL/hr, to complete over 4 hours [+/- 20 minutes]).
			Labs
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Any lab test value outside the reference range that the investigator considers to be clinically significant must be repeated, followed until satisfactory resolution.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Required for women of childbearing potential.
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Required for women of childbearing potential.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Procedures
  	BIOPSY BONE MARROW	Interval: --	Occurrences: --	Comments:	Optional fresh bone marrow biopsy (to be processed off site by Sponsor).
			Pre-Medications
◯	dexamethasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Can be tapered with subsequent cycles as follows (see protocol pg.74-75): if a subject does not experience an infusion-related reaction (IRR) or an IMT (e.g., CRS or neurological toxicity [NT]) in a given cycle, the dexamethasone premedication dose may be reduced to 10 mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 10 mg dexamethasone IV as premedication, dexamethasone may subsequently be reduced to 5mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 5 mg dexamethasone IV as premedication, dexamethasone may subsequently be omitted from the premedication regimen.		◯	dexamethasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Can be tapered with subsequent cycles as follows (see protocol pg.74-75): if a subject does not experience an infusion-related reaction (IRR) or an IMT (e.g., CRS or neurological toxicity [NT]) in a given cycle, the dexamethasone premedication dose may be reduced to 10 mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 10 mg dexamethasone IV as premedication, dexamethasone may subsequently be reduced to 5mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 5 mg dexamethasone IV as premedication, dexamethasone may subsequently be omitted from the premedication regimen.		◉	dexamethasone (DECADRON) IV 5 mg	Dose: 5 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Can be tapered with subsequent cycles as follows (see protocol pg.74-75): if a subject does not experience an infusion-related reaction (IRR) or an IMT (e.g., CRS or neurological toxicity [NT]) in a given cycle, the dexamethasone premedication dose may be reduced to 10 mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 10 mg dexamethasone IV as premedication, dexamethasone may subsequently be reduced to 5mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 5 mg dexamethasone IV as premedication, dexamethasone may subsequently be omitted from the premedication regimen.			Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Or equivalent (ex. Cetirizine 10 mg PO x 1).		  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Or IV; Administer 30 minutes prior to infusion.		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Or 1,000 mg; Administer 30 minutes prior to infusion.			Chemotherapy
  	INV-TNB-383B (TNB383B.0001/Pro00035531/Ganguly) 60 mg, Stabilizer 20 mL in sodium chloride 0.9% 250 mL IVPB	Dose: 60 mg	Route: intravenous	once PRN over 60 Minutes			Offset: 30 Minutes	Instructions:	Administer over 1 hour (+/- 10 mins) if no infusion reaction was experienced in previous cycle.
Prepared IV bag contains TNB-383B. Administer intravenously using 0.2-micron sterile inline filter over 120 minutes for initial infusion, then over 60 minutes for subsequent infusions. After the infusion, flush by adding 25 mL of 0.9% NaCl to the IV bag to ensure all drug is infused. Prepared bag is stable for 6 hours at room temperature from start of preparation until the end of the infusion. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TNB-383B 2 MG/ML INTRAVENOUS SOLN (TNB383B.0001/PRO00035531/GANGULY)	Medications	60 mg	Yes	Yes	INV-TNB-383B STABILIZER SOLN (TNB383B.0001/PRO00035531/GANGULY)	Medications	20 mL	Always	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	200 mL	Yes	Yes				Emergency Medications
  	tocilizumab (ACTEMRA) infusion (RESTRICTED) 8 mg/kg (Treatment Plan)	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	At the discretion of the investigator or per institutional guidance.			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.
		  	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		Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Symptom Directed Physical Exam
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Assess Adverse Events and Concomitant Medications/Therapy
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Diastolic and systolic blood pressure, heart rate, respiratory rate, and temperature.
		  	RESEARCH -  PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Day 15	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Symptom Directed Physical Exam
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Assess Adverse Events and Concomitant Medications/Therapy
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Diastolic and systolic blood pressure, heart rate, respiratory rate, and temperature.
		  	RESEARCH -  PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
OP Cycle 4	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Symptom Directed Physical Exam
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Assess Adverse Events and Concomitant Medications/Therapy
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Diastolic and systolic blood pressure, heart rate, respiratory rate, and temperature:
·        Pre-dose (up to 10 minutes)
·        30 minutes after start of infusion (+/- 10 minutes)
·        End of infusion (+/- 10 minutes)
·        One hour after end of infusion (+/- 10 minutes)
		  	RESEARCH -  PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	As clinically indicated:
·        Pre-dose (up to 10 minutes)
·        30 minutes after start of infusion (+/- 10 minutes)
·        End of infusion (+/- 10 minutes)
·        One hour after end of infusion (+/- 10 minutes)
			Line Care
  	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.			Treatment Conditions
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	If no infusion-related reactions occur during a cycle of TNB-383B, the investigator may consider shortening the duration of infusion for subsequent cycles to a minimum of 30 minutes.  If a subject experiences a grade 2 infusion reaction, the infusion should be stopped, and the reaction managed according to institutional guidelines. Once the reaction resolves to grade LESS than or EQUAL 1, the infusion may be restarted at half of the infusion rate at which the infusion reaction occurred (e.g. decrease to 62.5 mL/hr from 125 mL/hr, to complete over 4 hours [+/- 20 minutes]).
			Labs
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Any lab test value outside the reference range that the investigator considers to be clinically significant must be repeated, followed until satisfactory resolution.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Required for women of childbearing potential.
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Required for women of childbearing potential.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Pre-Medications
◯	dexamethasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Can be tapered with subsequent cycles as follows (see protocol pg.74-75): if a subject does not experience an infusion-related reaction (IRR) or an IMT (e.g., CRS or neurological toxicity [NT]) in a given cycle, the dexamethasone premedication dose may be reduced to 10 mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 10 mg dexamethasone IV as premedication, dexamethasone may subsequently be reduced to 5mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 5 mg dexamethasone IV as premedication, dexamethasone may subsequently be omitted from the premedication regimen.		◯	dexamethasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Can be tapered with subsequent cycles as follows (see protocol pg.74-75): if a subject does not experience an infusion-related reaction (IRR) or an IMT (e.g., CRS or neurological toxicity [NT]) in a given cycle, the dexamethasone premedication dose may be reduced to 10 mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 10 mg dexamethasone IV as premedication, dexamethasone may subsequently be reduced to 5mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 5 mg dexamethasone IV as premedication, dexamethasone may subsequently be omitted from the premedication regimen.		◉	dexamethasone (DECADRON) IV 5 mg	Dose: 5 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Can be tapered with subsequent cycles as follows (see protocol pg.74-75): if a subject does not experience an infusion-related reaction (IRR) or an IMT (e.g., CRS or neurological toxicity [NT]) in a given cycle, the dexamethasone premedication dose may be reduced to 10 mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 10 mg dexamethasone IV as premedication, dexamethasone may subsequently be reduced to 5mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 5 mg dexamethasone IV as premedication, dexamethasone may subsequently be omitted from the premedication regimen.			Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Or equivalent (ex. Cetirizine 10 mg PO x 1).		  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Or IV; Administer 30 minutes prior to infusion.		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Or 1,000 mg; Administer 30 minutes prior to infusion.			Chemotherapy
  	INV-TNB-383B (TNB383B.0001/Pro00035531/Ganguly) 60 mg, Stabilizer 20 mL in sodium chloride 0.9% 250 mL IVPB	Dose: 60 mg	Route: intravenous	once PRN over 60 Minutes			Offset: 30 Minutes	Instructions:	Administer over 1 hour (+/- 10 mins) if no infusion reaction was experienced in previous cycle.
Prepared IV bag contains TNB-383B. Administer intravenously using 0.2-micron sterile inline filter over 120 minutes for initial infusion, then over 60 minutes for subsequent infusions. After the infusion, flush by adding 25 mL of 0.9% NaCl to the IV bag to ensure all drug is infused. Prepared bag is stable for 6 hours at room temperature from start of preparation until the end of the infusion. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TNB-383B 2 MG/ML INTRAVENOUS SOLN (TNB383B.0001/PRO00035531/GANGULY)	Medications	60 mg	Yes	Yes	INV-TNB-383B STABILIZER SOLN (TNB383B.0001/PRO00035531/GANGULY)	Medications	20 mL	Always	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	200 mL	Yes	Yes				Emergency Medications
  	tocilizumab (ACTEMRA) infusion (RESTRICTED) 8 mg/kg (Treatment Plan)	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	At the discretion of the investigator or per institutional guidance.			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.
		  	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.
					
OP Cycle 5	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Symptom Directed Physical Exam
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Assess Adverse Events and Concomitant Medications/Therapy
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Diastolic and systolic blood pressure, heart rate, respiratory rate, and temperature:
·        Pre-dose (up to 10 minutes)
·        30 minutes after start of infusion (+/- 10 minutes)
·        End of infusion (+/- 10 minutes)
·        One hour after end of infusion (+/- 10 minutes)
		  	RESEARCH -  PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	As clinically indicated:
·        Pre-dose (up to 10 minutes)
·        30 minutes after start of infusion (+/- 10 minutes)
·        End of infusion (+/- 10 minutes)
·        One hour after end of infusion (+/- 10 minutes)
			Line Care
  	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.			Treatment Conditions
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	If no infusion-related reactions occur during a cycle of TNB-383B, the investigator may consider shortening the duration of infusion for subsequent cycles to a minimum of 30 minutes.  If a subject experiences a grade 2 infusion reaction, the infusion should be stopped, and the reaction managed according to institutional guidelines. Once the reaction resolves to grade LESS than or EQUAL 1, the infusion may be restarted at half of the infusion rate at which the infusion reaction occurred (e.g. decrease to 62.5 mL/hr from 125 mL/hr, to complete over 4 hours [+/- 20 minutes]).
			Labs
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Any lab test value outside the reference range that the investigator considers to be clinically significant must be repeated, followed until satisfactory resolution.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Required for women of childbearing potential.
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Required for women of childbearing potential.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Pre-Medications
◯	dexamethasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Can be tapered with subsequent cycles as follows (see protocol pg.74-75): if a subject does not experience an infusion-related reaction (IRR) or an IMT (e.g., CRS or neurological toxicity [NT]) in a given cycle, the dexamethasone premedication dose may be reduced to 10 mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 10 mg dexamethasone IV as premedication, dexamethasone may subsequently be reduced to 5mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 5 mg dexamethasone IV as premedication, dexamethasone may subsequently be omitted from the premedication regimen.		◯	dexamethasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Can be tapered with subsequent cycles as follows (see protocol pg.74-75): if a subject does not experience an infusion-related reaction (IRR) or an IMT (e.g., CRS or neurological toxicity [NT]) in a given cycle, the dexamethasone premedication dose may be reduced to 10 mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 10 mg dexamethasone IV as premedication, dexamethasone may subsequently be reduced to 5mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 5 mg dexamethasone IV as premedication, dexamethasone may subsequently be omitted from the premedication regimen.		◉	dexamethasone (DECADRON) IV 5 mg	Dose: 5 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Can be tapered with subsequent cycles as follows (see protocol pg.74-75): if a subject does not experience an infusion-related reaction (IRR) or an IMT (e.g., CRS or neurological toxicity [NT]) in a given cycle, the dexamethasone premedication dose may be reduced to 10 mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 10 mg dexamethasone IV as premedication, dexamethasone may subsequently be reduced to 5mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 5 mg dexamethasone IV as premedication, dexamethasone may subsequently be omitted from the premedication regimen.			Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Or equivalent (ex. Cetirizine 10 mg PO x 1).		  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Or IV; Administer 30 minutes prior to infusion.		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Or 1,000 mg; Administer 30 minutes prior to infusion.			Chemotherapy
  	INV-TNB-383B (TNB383B.0001/Pro00035531/Ganguly) 60 mg, Stabilizer 20 mL in sodium chloride 0.9% 250 mL IVPB	Dose: 60 mg	Route: intravenous	once PRN over 60 Minutes			Offset: 30 Minutes	Instructions:	Administer over 1 hour (+/- 10 mins) if no infusion reaction was experienced in previous cycle.
Prepared IV bag contains TNB-383B. Administer intravenously using 0.2-micron sterile inline filter over 120 minutes for initial infusion, then over 60 minutes for subsequent infusions. After the infusion, flush by adding 25 mL of 0.9% NaCl to the IV bag to ensure all drug is infused. Prepared bag is stable for 6 hours at room temperature from start of preparation until the end of the infusion. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TNB-383B 2 MG/ML INTRAVENOUS SOLN (TNB383B.0001/PRO00035531/GANGULY)	Medications	60 mg	Yes	Yes	INV-TNB-383B STABILIZER SOLN (TNB383B.0001/PRO00035531/GANGULY)	Medications	20 mL	Always	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	200 mL	Yes	Yes				Emergency Medications
  	tocilizumab (ACTEMRA) infusion (RESTRICTED) 8 mg/kg (Treatment Plan)	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	At the discretion of the investigator or per institutional guidance.			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.
		  	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.
					
OP Cycle 6	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Symptom Directed Physical Exam
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Assess Adverse Events and Concomitant Medications/Therapy
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Diastolic and systolic blood pressure, heart rate, respiratory rate, and temperature:
·        Pre-dose (up to 10 minutes)
·        30 minutes after start of infusion (+/- 10 minutes)
·        End of infusion (+/- 10 minutes)
·        One hour after end of infusion (+/- 10 minutes)
		  	RESEARCH -  PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	As clinically indicated:
·        Pre-dose (up to 10 minutes)
·        30 minutes after start of infusion (+/- 10 minutes)
·        End of infusion (+/- 10 minutes)
·        One hour after end of infusion (+/- 10 minutes)
			Line Care
  	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.			Treatment Conditions
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	If no infusion-related reactions occur during a cycle of TNB-383B, the investigator may consider shortening the duration of infusion for subsequent cycles to a minimum of 30 minutes.  If a subject experiences a grade 2 infusion reaction, the infusion should be stopped, and the reaction managed according to institutional guidelines. Once the reaction resolves to grade LESS than or EQUAL 1, the infusion may be restarted at half of the infusion rate at which the infusion reaction occurred (e.g. decrease to 62.5 mL/hr from 125 mL/hr, to complete over 4 hours [+/- 20 minutes]).
			Labs
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Any lab test value outside the reference range that the investigator considers to be clinically significant must be repeated, followed until satisfactory resolution.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Required for women of childbearing potential.
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Required for women of childbearing potential.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Pre-Medications
◯	dexamethasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Can be tapered with subsequent cycles as follows (see protocol pg.74-75): if a subject does not experience an infusion-related reaction (IRR) or an IMT (e.g., CRS or neurological toxicity [NT]) in a given cycle, the dexamethasone premedication dose may be reduced to 10 mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 10 mg dexamethasone IV as premedication, dexamethasone may subsequently be reduced to 5mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 5 mg dexamethasone IV as premedication, dexamethasone may subsequently be omitted from the premedication regimen.		◯	dexamethasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Can be tapered with subsequent cycles as follows (see protocol pg.74-75): if a subject does not experience an infusion-related reaction (IRR) or an IMT (e.g., CRS or neurological toxicity [NT]) in a given cycle, the dexamethasone premedication dose may be reduced to 10 mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 10 mg dexamethasone IV as premedication, dexamethasone may subsequently be reduced to 5mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 5 mg dexamethasone IV as premedication, dexamethasone may subsequently be omitted from the premedication regimen.		◉	dexamethasone (DECADRON) IV 5 mg	Dose: 5 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Can be tapered with subsequent cycles as follows (see protocol pg.74-75): if a subject does not experience an infusion-related reaction (IRR) or an IMT (e.g., CRS or neurological toxicity [NT]) in a given cycle, the dexamethasone premedication dose may be reduced to 10 mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 10 mg dexamethasone IV as premedication, dexamethasone may subsequently be reduced to 5mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 5 mg dexamethasone IV as premedication, dexamethasone may subsequently be omitted from the premedication regimen.			Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Or equivalent (ex. Cetirizine 10 mg PO x 1).		  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Or IV; Administer 30 minutes prior to infusion.		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Or 1,000 mg; Administer 30 minutes prior to infusion.			Chemotherapy
  	INV-TNB-383B (TNB383B.0001/Pro00035531/Ganguly) 60 mg, Stabilizer 20 mL in sodium chloride 0.9% 250 mL IVPB	Dose: 60 mg	Route: intravenous	once PRN over 60 Minutes			Offset: 30 Minutes	Instructions:	Administer over 1 hour (+/- 10 mins) if no infusion reaction was experienced in previous cycle.
Prepared IV bag contains TNB-383B. Administer intravenously using 0.2-micron sterile inline filter over 120 minutes for initial infusion, then over 60 minutes for subsequent infusions. After the infusion, flush by adding 25 mL of 0.9% NaCl to the IV bag to ensure all drug is infused. Prepared bag is stable for 6 hours at room temperature from start of preparation until the end of the infusion. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TNB-383B 2 MG/ML INTRAVENOUS SOLN (TNB383B.0001/PRO00035531/GANGULY)	Medications	60 mg	Yes	Yes	INV-TNB-383B STABILIZER SOLN (TNB383B.0001/PRO00035531/GANGULY)	Medications	20 mL	Always	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	200 mL	Yes	Yes				Emergency Medications
  	tocilizumab (ACTEMRA) infusion (RESTRICTED) 8 mg/kg (Treatment Plan)	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	At the discretion of the investigator or per institutional guidance.			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.
		  	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 2	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Symptom Directed Physical Exam
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Assess Adverse Events and Concomitant Medications/Therapy
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Diastolic and systolic blood pressure, heart rate, respiratory rate, and temperature.
		  	RESEARCH -  PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
				Day 15	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Symptom Directed Physical Exam
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Assess Adverse Events and Concomitant Medications/Therapy
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Diastolic and systolic blood pressure, heart rate, respiratory rate, and temperature.
		  	RESEARCH -  PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	As clinically indicated.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --				Day 22	Perform every 1 day x1		Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
OP Cycle 7	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Symptom Directed Physical Exam
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Assess Adverse Events and Concomitant Medications/Therapy
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Diastolic and systolic blood pressure, heart rate, respiratory rate, and temperature:
·        Pre-dose (up to 10 minutes)
·        30 minutes after start of infusion (+/- 10 minutes)
·        End of infusion (+/- 10 minutes)
·        One hour after end of infusion (+/- 10 minutes)
		  	RESEARCH -  PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	As clinically indicated:
·        Pre-dose (up to 10 minutes)
·        30 minutes after start of infusion (+/- 10 minutes)
·        End of infusion (+/- 10 minutes)
·        One hour after end of infusion (+/- 10 minutes)
			Line Care
  	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.			Treatment Conditions
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	If no infusion-related reactions occur during a cycle of TNB-383B, the investigator may consider shortening the duration of infusion for subsequent cycles to a minimum of 30 minutes.  If a subject experiences a grade 2 infusion reaction, the infusion should be stopped, and the reaction managed according to institutional guidelines. Once the reaction resolves to grade LESS than or EQUAL 1, the infusion may be restarted at half of the infusion rate at which the infusion reaction occurred (e.g. decrease to 62.5 mL/hr from 125 mL/hr, to complete over 4 hours [+/- 20 minutes]).
			Labs
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Any lab test value outside the reference range that the investigator considers to be clinically significant must be repeated, followed until satisfactory resolution.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Required for women of childbearing potential.
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Required for women of childbearing potential.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Pre-Medications
◯	dexamethasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Can be tapered with subsequent cycles as follows (see protocol pg.74-75): if a subject does not experience an infusion-related reaction (IRR) or an IMT (e.g., CRS or neurological toxicity [NT]) in a given cycle, the dexamethasone premedication dose may be reduced to 10 mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 10 mg dexamethasone IV as premedication, dexamethasone may subsequently be reduced to 5mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 5 mg dexamethasone IV as premedication, dexamethasone may subsequently be omitted from the premedication regimen.		◯	dexamethasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Can be tapered with subsequent cycles as follows (see protocol pg.74-75): if a subject does not experience an infusion-related reaction (IRR) or an IMT (e.g., CRS or neurological toxicity [NT]) in a given cycle, the dexamethasone premedication dose may be reduced to 10 mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 10 mg dexamethasone IV as premedication, dexamethasone may subsequently be reduced to 5mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 5 mg dexamethasone IV as premedication, dexamethasone may subsequently be omitted from the premedication regimen.		◉	dexamethasone (DECADRON) IV 5 mg	Dose: 5 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Can be tapered with subsequent cycles as follows (see protocol pg.74-75): if a subject does not experience an infusion-related reaction (IRR) or an IMT (e.g., CRS or neurological toxicity [NT]) in a given cycle, the dexamethasone premedication dose may be reduced to 10 mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 10 mg dexamethasone IV as premedication, dexamethasone may subsequently be reduced to 5mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 5 mg dexamethasone IV as premedication, dexamethasone may subsequently be omitted from the premedication regimen.			Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Or equivalent (ex. Cetirizine 10 mg PO x 1).		  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Or IV; Administer 30 minutes prior to infusion.		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Or 1,000 mg; Administer 30 minutes prior to infusion.			Chemotherapy
  	INV-TNB-383B (TNB383B.0001/Pro00035531/Ganguly) 60 mg, Stabilizer 20 mL in sodium chloride 0.9% 250 mL IVPB	Dose: 60 mg	Route: intravenous	once PRN over 60 Minutes			Offset: 30 Minutes	Instructions:	Administer over 1 hour (+/- 10 mins) if no infusion reaction was experienced in previous cycle.
Prepared IV bag contains TNB-383B. Administer intravenously using 0.2-micron sterile inline filter over 120 minutes for initial infusion, then over 60 minutes for subsequent infusions. After the infusion, flush by adding 25 mL of 0.9% NaCl to the IV bag to ensure all drug is infused. Prepared bag is stable for 6 hours at room temperature from start of preparation until the end of the infusion. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TNB-383B 2 MG/ML INTRAVENOUS SOLN (TNB383B.0001/PRO00035531/GANGULY)	Medications	60 mg	Yes	Yes	INV-TNB-383B STABILIZER SOLN (TNB383B.0001/PRO00035531/GANGULY)	Medications	20 mL	Always	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	200 mL	Yes	Yes				Emergency Medications
  	tocilizumab (ACTEMRA) infusion (RESTRICTED) 8 mg/kg (Treatment Plan)	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	At the discretion of the investigator or per institutional guidance.			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.
		  	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.
					
OP Cycle 8	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Symptom Directed Physical Exam
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Assess Adverse Events and Concomitant Medications/Therapy
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Diastolic and systolic blood pressure, heart rate, respiratory rate, and temperature:
·        Pre-dose (up to 10 minutes)
·        30 minutes after start of infusion (+/- 10 minutes)
·        End of infusion (+/- 10 minutes)
·        One hour after end of infusion (+/- 10 minutes)
		  	RESEARCH -  PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	As clinically indicated:
·        Pre-dose (up to 10 minutes)
·        30 minutes after start of infusion (+/- 10 minutes)
·        End of infusion (+/- 10 minutes)
·        One hour after end of infusion (+/- 10 minutes)
			Line Care
  	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.			Treatment Conditions
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	If no infusion-related reactions occur during a cycle of TNB-383B, the investigator may consider shortening the duration of infusion for subsequent cycles to a minimum of 30 minutes.  If a subject experiences a grade 2 infusion reaction, the infusion should be stopped, and the reaction managed according to institutional guidelines. Once the reaction resolves to grade LESS than or EQUAL 1, the infusion may be restarted at half of the infusion rate at which the infusion reaction occurred (e.g. decrease to 62.5 mL/hr from 125 mL/hr, to complete over 4 hours [+/- 20 minutes]).
			Labs
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Any lab test value outside the reference range that the investigator considers to be clinically significant must be repeated, followed until satisfactory resolution.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Required for women of childbearing potential.
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Required for women of childbearing potential.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Pre-Medications
◯	dexamethasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Can be tapered with subsequent cycles as follows (see protocol pg.74-75): if a subject does not experience an infusion-related reaction (IRR) or an IMT (e.g., CRS or neurological toxicity [NT]) in a given cycle, the dexamethasone premedication dose may be reduced to 10 mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 10 mg dexamethasone IV as premedication, dexamethasone may subsequently be reduced to 5mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 5 mg dexamethasone IV as premedication, dexamethasone may subsequently be omitted from the premedication regimen.		◯	dexamethasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Can be tapered with subsequent cycles as follows (see protocol pg.74-75): if a subject does not experience an infusion-related reaction (IRR) or an IMT (e.g., CRS or neurological toxicity [NT]) in a given cycle, the dexamethasone premedication dose may be reduced to 10 mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 10 mg dexamethasone IV as premedication, dexamethasone may subsequently be reduced to 5mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 5 mg dexamethasone IV as premedication, dexamethasone may subsequently be omitted from the premedication regimen.		◉	dexamethasone (DECADRON) IV 5 mg	Dose: 5 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Can be tapered with subsequent cycles as follows (see protocol pg.74-75): if a subject does not experience an infusion-related reaction (IRR) or an IMT (e.g., CRS or neurological toxicity [NT]) in a given cycle, the dexamethasone premedication dose may be reduced to 10 mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 10 mg dexamethasone IV as premedication, dexamethasone may subsequently be reduced to 5mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 5 mg dexamethasone IV as premedication, dexamethasone may subsequently be omitted from the premedication regimen.			Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Or equivalent (ex. Cetirizine 10 mg PO x 1).		  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Or IV; Administer 30 minutes prior to infusion.		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Or 1,000 mg; Administer 30 minutes prior to infusion.			Chemotherapy
  	INV-TNB-383B (TNB383B.0001/Pro00035531/Ganguly) 60 mg, Stabilizer 20 mL in sodium chloride 0.9% 250 mL IVPB	Dose: 60 mg	Route: intravenous	once PRN over 60 Minutes			Offset: 30 Minutes	Instructions:	Administer over 1 hour (+/- 10 mins) if no infusion reaction was experienced in previous cycle.
Prepared IV bag contains TNB-383B. Administer intravenously using 0.2-micron sterile inline filter over 120 minutes for initial infusion, then over 60 minutes for subsequent infusions. After the infusion, flush by adding 25 mL of 0.9% NaCl to the IV bag to ensure all drug is infused. Prepared bag is stable for 6 hours at room temperature from start of preparation until the end of the infusion. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TNB-383B 2 MG/ML INTRAVENOUS SOLN (TNB383B.0001/PRO00035531/GANGULY)	Medications	60 mg	Yes	Yes	INV-TNB-383B STABILIZER SOLN (TNB383B.0001/PRO00035531/GANGULY)	Medications	20 mL	Always	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	200 mL	Yes	Yes				Emergency Medications
  	tocilizumab (ACTEMRA) infusion (RESTRICTED) 8 mg/kg (Treatment Plan)	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	At the discretion of the investigator or per institutional guidance.			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.
		  	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.
					
OP Cycle 9	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Symptom Directed Physical Exam
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Assess Adverse Events and Concomitant Medications/Therapy
		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Diastolic and systolic blood pressure, heart rate, respiratory rate, and temperature:
·        Pre-dose (up to 10 minutes)
·        30 minutes after start of infusion (+/- 10 minutes)
·        End of infusion (+/- 10 minutes)
·        One hour after end of infusion (+/- 10 minutes)
		  	RESEARCH -  PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	As clinically indicated:
·        Pre-dose (up to 10 minutes)
·        30 minutes after start of infusion (+/- 10 minutes)
·        End of infusion (+/- 10 minutes)
·        One hour after end of infusion (+/- 10 minutes)
			Line Care
  	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.			Treatment Conditions
  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	If no infusion-related reactions occur during a cycle of TNB-383B, the investigator may consider shortening the duration of infusion for subsequent cycles to a minimum of 30 minutes.  If a subject experiences a grade 2 infusion reaction, the infusion should be stopped, and the reaction managed according to institutional guidelines. Once the reaction resolves to grade LESS than or EQUAL 1, the infusion may be restarted at half of the infusion rate at which the infusion reaction occurred (e.g. decrease to 62.5 mL/hr from 125 mL/hr, to complete over 4 hours [+/- 20 minutes]).
			Labs
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Any lab test value outside the reference range that the investigator considers to be clinically significant must be repeated, followed until satisfactory resolution.
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Required for women of childbearing potential.
		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Required for women of childbearing potential.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Outpatient Electrolyte Replacement Protocol
  	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	The protocol applies only if the following is met. 
1. SCr LESS than 1.5; 
2. Potassium level LESS than 3.5 mEq/L; 
3. Recent pre-infusion labs.   

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

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

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

If patient meets criteria, order THERAPY PLAN called "Outpatient Electrolyte Replacement". 
Sign electrolyte replacement order as Per protocol: cosign required.
			Pre-Medications
◯	dexamethasone (DECADRON) IV 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Can be tapered with subsequent cycles as follows (see protocol pg.74-75): if a subject does not experience an infusion-related reaction (IRR) or an IMT (e.g., CRS or neurological toxicity [NT]) in a given cycle, the dexamethasone premedication dose may be reduced to 10 mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 10 mg dexamethasone IV as premedication, dexamethasone may subsequently be reduced to 5mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 5 mg dexamethasone IV as premedication, dexamethasone may subsequently be omitted from the premedication regimen.		◯	dexamethasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Can be tapered with subsequent cycles as follows (see protocol pg.74-75): if a subject does not experience an infusion-related reaction (IRR) or an IMT (e.g., CRS or neurological toxicity [NT]) in a given cycle, the dexamethasone premedication dose may be reduced to 10 mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 10 mg dexamethasone IV as premedication, dexamethasone may subsequently be reduced to 5mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 5 mg dexamethasone IV as premedication, dexamethasone may subsequently be omitted from the premedication regimen.		◉	dexamethasone (DECADRON) IV 5 mg	Dose: 5 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Can be tapered with subsequent cycles as follows (see protocol pg.74-75): if a subject does not experience an infusion-related reaction (IRR) or an IMT (e.g., CRS or neurological toxicity [NT]) in a given cycle, the dexamethasone premedication dose may be reduced to 10 mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 10 mg dexamethasone IV as premedication, dexamethasone may subsequently be reduced to 5mg IV. If a subject does not experience an IRR or IMT in a cycle where they received 5 mg dexamethasone IV as premedication, dexamethasone may subsequently be omitted from the premedication regimen.			Pre-Medications
  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to infusion.  Or equivalent (ex. Cetirizine 10 mg PO x 1).		  	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Or IV; Administer 30 minutes prior to infusion.		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Or 1,000 mg; Administer 30 minutes prior to infusion.			Chemotherapy
  	INV-TNB-383B (TNB383B.0001/Pro00035531/Ganguly) 60 mg, Stabilizer 20 mL in sodium chloride 0.9% 250 mL IVPB	Dose: 60 mg	Route: intravenous	once PRN over 60 Minutes			Offset: 30 Minutes	Instructions:	Administer over 1 hour (+/- 10 mins) if no infusion reaction was experienced in previous cycle.
Prepared IV bag contains TNB-383B. Administer intravenously using 0.2-micron sterile inline filter over 120 minutes for initial infusion, then over 60 minutes for subsequent infusions. After the infusion, flush by adding 25 mL of 0.9% NaCl to the IV bag to ensure all drug is infused. Prepared bag is stable for 6 hours at room temperature from start of preparation until the end of the infusion. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-TNB-383B 2 MG/ML INTRAVENOUS SOLN (TNB383B.0001/PRO00035531/GANGULY)	Medications	60 mg	Yes	Yes	INV-TNB-383B STABILIZER SOLN (TNB383B.0001/PRO00035531/GANGULY)	Medications	20 mL	Always	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	200 mL	Yes	Yes				Emergency Medications
  	tocilizumab (ACTEMRA) infusion (RESTRICTED) 8 mg/kg (Treatment Plan)	Dose: 8 mg/kg	Route: intravenous	once for 1 dose	Start: S			Instructions:	At the discretion of the investigator or per institutional guidance.			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.
		  	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.