Protocol Index	

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IP DARATUMUMAB 	

Types:      ONCOLOGY TREATMENT
Synonyms:  MULT, MYELO, DARA , DAZ, DAYS, DARZ

Cycle 1	Repeat 1 time	Cycle length: 365 days	Day 1	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION 64	Interval: Once	Occurrences: --	Comments:	Verify Hep B panel status prior to cycle. Date *** of panel. Result positive/negative/pending/unknown:22867

The required components for the hepatitis B panel includes: Hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (anti-HBc), and hepatitis B antibody (anti-HBs).
			Provider Communication
  	ONC PROVIDER COMMUNICATION 5	Interval: Once	Occurrences: --	Comments:	Use baseline weight to calculate dose. Adjust dose for weight gains/losses of greater than or equal to 10%.
			Labs
☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		☑	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		☐	LDH	Interval: Once	Occurrences: --		☐	URIC ACID LEVEL	Interval: Once	Occurrences: --			Labs
  	TYPE AND SCREEN	Interval: Once	Occurrences: --	Comments:	Draw type and screen as baseline BEFORE Daratumumab
			Nursing Orders
  	ONC NURSING COMMUNICATION 73	Interval: Until discontinued	Occurrences: --	Comments:	Draw type and screen BEFORE each infusion.
			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.			Pre-Medications
◉	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 100 mg	Dose: 100 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		◯	dexamethasone (DECADRON) IV 40 mg	Dose: 40 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.			Pre-Medications
  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: Once	Occurrences: --	Comments:	Please go to Meds & Orders to order: valACYclovir 500 mg po Daily.
			Chemotherapy
◯	daratumumab 16 mg/kg in sodium chloride 0.9% 1,000 mL IVPB	Dose: 16 mg/kg	Route: intravenous	once @ 50 mL/hr for 1 dose			Offset: 30 Minutes	Instructions:	First infusion (1,000 mL volume): Infuse at 50 mL/hour for the first hour. If no infusion reactions occur, may increase the rate by 50 mL/hour every hour (maximum rate: 200 mL/hour).	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DARATUMUMAB 20 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	1,000 mL	Yes	Yes			◉	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 30 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.			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	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.				Days 8,15,22,29,36,43,50	Perform every 7 days x7		Labs
☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		☑	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		☐	LDH	Interval: Once	Occurrences: --		☐	URIC ACID LEVEL	Interval: Once	Occurrences: --			Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
◉	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 100 mg	Dose: 100 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		◯	dexamethasone (DECADRON) IV 40 mg	Dose: 40 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.			Pre-Medications
  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: Once	Occurrences: --	Comments:	Please go to Meds & Orders to order: valACYclovir 500 mg po Daily.
			Chemotherapy
◯	daratumumab 16 mg/kg in sodium chloride 0.9% 1,000 mL IVPB	Dose: 16 mg/kg	Route: intravenous	once @ 50 mL/hr for 1 dose			Offset: 30 Minutes	Instructions:	First infusion (1,000 mL volume): Infuse at 50 mL/hour for the first hour. If no infusion reactions occur, may increase the rate by 50 mL/hour every hour (maximum rate: 200 mL/hour).	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DARATUMUMAB 20 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	1,000 mL	Yes	Yes			◉	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 30 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.				Days 57,71,85,99,113,127,141,155	Perform every 14 days x8		Labs
☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		☑	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		☐	LDH	Interval: Once	Occurrences: --		☐	URIC ACID LEVEL	Interval: Once	Occurrences: --			Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
◉	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 100 mg	Dose: 100 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		◯	dexamethasone (DECADRON) IV 40 mg	Dose: 40 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.			Pre-Medications
  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: Once	Occurrences: --	Comments:	Please go to Meds & Orders to order: valACYclovir 500 mg po Daily.
			Chemotherapy
◯	daratumumab 16 mg/kg in sodium chloride 0.9% 1,000 mL IVPB	Dose: 16 mg/kg	Route: intravenous	once @ 50 mL/hr for 1 dose			Offset: 30 Minutes	Instructions:	First infusion (1,000 mL volume): Infuse at 50 mL/hour for the first hour. If no infusion reactions occur, may increase the rate by 50 mL/hour every hour (maximum rate: 200 mL/hour).	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DARATUMUMAB 20 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	1,000 mL	Yes	Yes			◉	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 30 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.				Days 169,197,225,253,281,309,337,365	Perform every 28 days x8		Labs
☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		☑	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		☐	LDH	Interval: Once	Occurrences: --		☐	URIC ACID LEVEL	Interval: Once	Occurrences: --			Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
◉	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 100 mg	Dose: 100 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		◯	dexamethasone (DECADRON) IV 40 mg	Dose: 40 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.			Pre-Medications
  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: Once	Occurrences: --	Comments:	Please go to Meds & Orders to order: valACYclovir 500 mg po Daily.
			Chemotherapy
◯	daratumumab 16 mg/kg in sodium chloride 0.9% 1,000 mL IVPB	Dose: 16 mg/kg	Route: intravenous	once @ 50 mL/hr for 1 dose			Offset: 30 Minutes	Instructions:	First infusion (1,000 mL volume): Infuse at 50 mL/hour for the first hour. If no infusion reactions occur, may increase the rate by 50 mL/hour every hour (maximum rate: 200 mL/hour).	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DARATUMUMAB 20 MG/ML INTRAVENOUS SOLUTION	Medications	16 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	1,000 mL	Yes	Yes			◉	daratumumab-hyaluronidase-fihj (DARZALEX FASPRO) injection (RESTRICTED) 1,800 mg	Dose: 1,800 mg	Route: subcutaneous	once for 1 dose			Offset: 30 Minutes	Instructions:	For subcutaneous use only. Pre-medicate with a corticosteroid, acetaminophen and a histamine-1 receptor antagonist. Administer subcutaneously into the abdomen over approximately 3 to 5 minutes.