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IP RSH PRO00038249/ H-55540 AXATILIMAB	

Types:      Research Oncology Treatment
Synonyms:  H-55540, AXATILIMAB, AXATI, GVHD

Screening	Repeat 1 time	Cycle length: 28 days	Eligibility Screening and Consent (may not exceed 28 days)	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: Until discontinued	Occurrences: --	Comments:	Ensure informed consent signed
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --			Imaging
  	ECG 12-LEAD	Interval: Once	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --			Labs
  	HCG QUANTITATIVE, SERUM	Interval: Once	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Medical history
		  	ONC PROVIDER COMMUNICATION 2	Interval: Until discontinued	Occurrences: --	Comments:	Concomitant medications
			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: Until discontinued	Occurrences: --	Comments:	Physical Examination
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: Until discontinued	Occurrences: --	Comments:	Chronic GVHD diagnosis and staging using NIH criteria.
		  	ONC PROVIDER COMMUNICATION 5	Interval: Until discontinued	Occurrences: --	Comments:	KPS Assessment
					
Cycle 1	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --	Comments:	Patient must be observed for 2 hours post-infusion for any infusion related reactions.
			Provider Communication
  	ONC PROVIDER COMMUNICATION 3	Interval: Until discontinued	Occurrences: --	Comments:	Physical Examination
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --			Labs
  	HCG QUANTITATIVE, SERUM	Interval: Once	Occurrences: --			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
  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	(30-60 minutes before Axatilimab)		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	(30-60 minutes before Axatilimab)			Medications
  	INV-AXATILIMAB (H-55540/PRO00038249) IV ORDERABLE 0.3 mg/kg (Treatment Plan)	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

Infusion can be given over 30 minutes +/- 5 to 10 minutes (25-40 minutes total infusion time) per the protocol. 			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						Day 15	Perform every 1 day x1		Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --	Comments:	Patient must be observed for 2 hours post-infusion for any infusion related reactions.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --			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
  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	(30-60 minutes before Axatilimab)		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	(30-60 minutes before Axatilimab)			Medications
  	INV-AXATILIMAB (H-55540/PRO00038249) IV ORDERABLE 0.3 mg/kg (Treatment Plan)	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose	Start: S			Instructions:	Caution: New Drug-Limited by Federal (USA) Law to Investigational use.

Infusion can be given over 30 minutes +/- 5 to 10 minutes (25-40 minutes total infusion time) per the protocol. 			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