RESEARCH PRO00024239 / GABER ISATUXIMAB INFUSION		version 7/2/2020		

Nursing Orders 	

	
	Interval	Defer Until	Duration	
	☐	Insert Peripheral IV or Access Portacath	Every visit	S	Until discont'd	
		Please insert peripheral IV with access for blood draws.		
	☐	Vital signs - T/P/R/BP Per Unit Protocol	Every visit	S	Until discont'd	
		Prior to infusion.
	1 hour after start of infusion.
	At the end of infusion.
	1 hour after infusion.		
	☐	sodium chloride 0.9% flush 250 mL	Every visit	S	Until discont'd	
		250 mL, intravenous, once PRN, line care, Starting when released, Until Discontinued		
	☐	Discontinue IV	Every visit	S	Until discont'd	
		No details available for preview		
	☐	Weigh patient	Treatments: 1, 3, 5, 7	S	Until discont'd	
		Clinic Performed, Normal		

Hypersensitivity 	

	
	Interval	Defer Until	Duration	
	☐	Nursing communication	PRN	S	Until discont'd	
		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.		
	☐	Nursing communication	PRN	S	Until discont'd	
		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.		
	☐	Nursing communication	PRN	S	Until discont'd	
		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	PRN	S	Until discont'd	
		25 mg, intravenous, PRN, Allergic reaction, Starting when released, Until Discontinued		
	☐	cetirizine (ZyrTEC) tablet 10 mg	PRN	S	Until discont'd	
		10 mg, oral, once PRN, allergic reaction, Starting when released, Until Discontinued		
	☐	famotidine (PEPCID) injection 20 mg	PRN	S	Until discont'd	
		20 mg, intravenous, PRN, Allergic reaction, Starting when released, Until Discontinued		
	☐	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	PRN	S	Until discont'd	
		100 mg, intravenous, PRN, Allergic reaction, Until Discontinued		
	☐	dexAMETHasone (DECADRON) IV 4 mg	PRN	S	Until discont'd	
		4 mg, intravenous, PRN, Allergic reaction, Until Discontinued		
	☐	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	PRN	S	Until discont'd	
		0.3 mg, subcutaneous, PRN, anaphylaxis, Starting when released, Until Discontinued		

Pre-Medications 	

	
	Interval	Defer Until	Duration	
	☐	acetaminophen (TYLENOL) tablet 650 mg	PRN	S	Until discont'd	
		650 mg, oral, once, Starting when released
	650mg or 1000mg; Given 15-30 minutes prior to isatuximab.  For a participant who has no IR for the first 4 infusions.  Premedication for the subsequent infusions is optional at the investigator's discretion.  However, if during the subsequent infusions without premedication the participant experiences an IR (any grade), premedication must be restarted for all subsequent infusions.
	Maximum of 4 grams of acetaminophen per day from all sources. (Cirrhosis patients maximum: 2 grams per day from all sources).		
	☐	acetaminophen (TYLENOL) tablet 975 mg	PRN	S	Until discont'd	
		1,000 mg, oral, once, Starting when released
	650mg or 1000mg; Given 15-30 minutes prior to isatuximab.  For a participant who has no IR for the first 4 infusions.  Premedication for the subsequent infusions is optional at the investigator's discretion.  However, if during the subsequent infusions without premedication the participant experiences an IR (any grade), premedication must be restarted for all subsequent infusions.
	Maximum of 4 grams of acetaminophen per day from all sources. (Cirrhosis patients maximum: 2 grams per day from all sources).		
	☐	famotidine (PEPCID) injection 20 mg	PRN	S	Until discont'd	
		20 mg, intravenous, once, Starting when released
	Given 15-30 minutes prior to isatuximab.  For a participant who has no IR for the first 4 infusions.  Premedication for the subsequent infusions is optional at the investigator's discretion.  However, if during the subsequent infusions without premedication the participant experiences an IR (any grade), premedication must be restarted for all subsequent infusions.		
	☐	diphenhydrAMINE (BENADRYL) injection 25 mg	PRN	S	Until discont'd	
		25 mg, intravenous, once, Starting when released
	25mg or 50mg given IV push; Given 15-30 minutes prior to isatuximab.  For a participant who has no IR for the first 4 infusions.  Premedication for the subsequent infusions is optional at the investigator's discretion.  However, if during the subsequent infusions without premedication the participant experiences an IR (any grade), premedication must be restarted for all subsequent infusions.		
	☐	diphenhydrAMINE (BENADRYL) injection 50 mg	PRN	S	Until discont'd	
		50 mg, intravenous, once, Starting when released
	25mg or 50mg given IV push; Given 15-30 minutes prior to isatuximab.  For a participant who has no IR for the first 4 infusions.  Premedication for the subsequent infusions is optional at the investigator's discretion.  However, if during the subsequent infusions without premedication the participant experiences an IR (any grade), premedication must be restarted for all subsequent infusions.		
	☐	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 100 mg	PRN	S	Until discont'd	
		100 mg, intravenous, once, Starting when released
	Given 15-30 minutes prior to isatuximab.  For a participant who has no IR for the first 4 infusions.  Premedication for the subsequent infusions is optional at the investigator's discretion.  However, if during the subsequent infusions without premedication the participant experiences an IR (any grade), premedication must be restarted for all subsequent infusions.		
	☐	montelukast (SINGULAIR) tablet 10 mg	PRN	S	Until discont'd	
		10 mg, oral, once, Starting when released
	Given 15-30 minutes prior to isatuximab.  For a participant who has no IR for the first 4 infusions.  Premedication for the subsequent infusions is optional at the investigator's discretion.  However, if during the subsequent infusions without premedication the participant experiences an IR (any grade), premedication must be restarted for all subsequent infusions.		

Labs 	

	
	Interval	Defer Until	Duration	
	☐	Nursing communication	Every visit	S	Until discont'd	
		Please draw research labs prior to start of infusion and/or end of infusion.  Tubes provided by research nurse with instructions.		

Chemotherapy 	

	
	Interval	Defer Until	Duration	
	☐	Nursing communication	Every visit	S	Until discont'd	
		ISATUXIMAB INFUSION:  Administer intravenously using a 0.2 micron inline filter at a rate of: 
	1st infusion: 175mg/hour, if no infusion reaction, may increase by 50mg/hr every 30 minutes, up to 400mg/hr maximum.
	Subsequent infusions: 175mg/hr, if no infusion reaction, may increase by 100mg/hr every 30 minutes, up to 400mg/hr maximum.
	IDS Pharmacy will provide drug.