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IP RESEARCH INCA34176-357 H-56778 HILL	

Types:      Research Oncology Treatment
Synonyms:  

Cycle 1	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 5	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E) performed on Day 1 will be the baseline for cGVHD response assessment during treatment and post-treatment follow-up.
		  	ONC PROVIDER COMMUNICATION 6	Interval: Once	Occurrences: --	Comments:	Research coordinator/physician to verify eligibility (inclusion/exclusion criteria).
		  	ONC PROVIDER COMMUNICATION 7	Interval: Once	Occurrences: --	Comments:	Document corticosteroids start date and dose
		  	ONC PROVIDER COMMUNICATION 8	Interval: Once	Occurrences: --	Comments:	Document KPS and physical examination
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	LIPID PANEL	Interval: Once	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: Once	Occurrences: --	Comments:	For women of child-bearing potential; must be done within 72 hours of C1D1
		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --	Comments:	Record vitals  pre-infusion, during the infusion, at the end of infusion, 30 minutes post infusion and 90 minutes post infusion. Blood pressure and pulse will be taken with the participant in the recumbent, semi-recumbent, or sitting position after 5 minutes of rest.
		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --		  	ONC NURSING COMMUNICATION 6	Interval: Once	Occurrences: --	Comments:	Collect research labs based on draw order
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Bone Turnover Makers (BAP and CTX): Blood; serum.
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	PK/ADA Sampling (PRE-INFUSION): Blood; plasma. 
Collect 2-HOURS PRE-infusion, fill tube completely and GENTLY mix (without shaking to avoid hemolysis) by slowly inverting the collection tube 6-8 times. If an indwelling catheter is used, saline must be used to keep the cannula patient, and the first 1mL of blood from each sampling will be discarded. Place the collection tube in an ice bath or crushed ice. Ice blocks are acceptable, but icy water must surround the samples
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Serum Biomarkers: Blood; serum.
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Whole Blood PBMCs
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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					Post Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Collect POST-infusion (up to 10 minutes post-transfusion). Fill tube completely and GENTLY mix (without shaking to avoid hemolysis) by slowly inverting the collection tube 6-8 times. If an indwelling catheter is used, saline must be used to keep the cannula patient, and the first 1mL of blood from each sampling will be discarded. Place the collection tube in an ice bath or crushed ice. Ice blocks are acceptable, but icy water must surround the samples
			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.				Day 8	Perform every 1 day x1			Research tolerance: -2/+2 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: Once	Occurrences: --			Nursing Orders
  	OK TO USE	Interval: Once	Occurrences: --			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Serum Biomarkers: Blood; serum.
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	PK Sampling  (PRE-INFUSION): Blood; plasma. 
Collect PRE-infusion. Fill tube completely and GENTLY mix (without shaking to avoid hemolysis) by slowly inverting the collection tube 6-8 times. If an indwelling catheter is used, saline must be used to keep the cannula patient, and the first 1mL of blood from each sampling will be discarded. Place the collection tube in an ice bath or crushed ice. Ice blocks are acceptable, but icy water must surround the samples
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Whole Blood PBMCs
				Day 15	Perform every 1 day x1			Research tolerance: -2/+2 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --	Comments:	Pre-infusion, during the infusion, at the end of infusion, 30 minutes post infusion and 90 minutes post infusion. Blood pressure and pulse will be taken with the participant in the recumbent, semi-recumbent, or sitting position after 5 minutes of rest.
		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --		  	ONC NURSING COMMUNICATION 6	Interval: Once	Occurrences: --	Comments:	Collect research labs based on draw order
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.				Day 22	Perform every 1 day x1			Research tolerance: -2/+2 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: Once	Occurrences: --			Nursing Orders
  	OK TO USE	Interval: Once	Occurrences: --			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S							
Cycle 2	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 8	Interval: Once	Occurrences: --	Comments:	Document KPS and physical examination
		  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
		  	ONC PROVIDER COMMUNICATION 12	Interval: Once	Occurrences: --	Comments:	Confirm PFTs ordered  (D1 of cycles 2-6)
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	LIPID PANEL	Interval: Once	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: Once	Occurrences: --	Comments:	For women of child-bearing potential; must be done within 72 hours of C1D1
		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --		  	ONC NURSING COMMUNICATION 6	Interval: Once	Occurrences: --	Comments:	Collect research labs based on draw order
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	PK/ADA Sampling (PRE-INFUSION): Blood; plasma. 
Collect PRE-infusion, fill tube completely and GENTLY mix (without shaking to avoid hemolysis) by slowly inverting the collection tube 6-8 times. If an indwelling catheter is used, saline must be used to keep the cannula patient, and the first 1mL of blood from each sampling will be discarded. Place the collection tube in an ice bath or crushed ice. Ice blocks are acceptable, but icy water must surround the samples
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Serum Biomarkers: Blood; serum.
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Whole Blood PBMCs
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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					Post Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Collect POST-infusion (up to 10 minutes post-transfusion). Fill tube completely and GENTLY mix (without shaking to avoid hemolysis) by slowly inverting the collection tube 6-8 times. If an indwelling catheter is used, saline must be used to keep the cannula patient, and the first 1mL of blood from each sampling will be discarded. Place the collection tube in an ice bath or crushed ice. Ice blocks are acceptable, but icy water must surround the samples
			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.				Day 15	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.					
Cycle 3	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 8	Interval: Once	Occurrences: --	Comments:	Document KPS and physical examination
		  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
		  	ONC PROVIDER COMMUNICATION 12	Interval: Once	Occurrences: --	Comments:	Confirm PFTs ordered  (D1 of cycles 2-6)
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	LIPID PANEL	Interval: Once	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: Once	Occurrences: --	Comments:	For women of child-bearing potential; must be done within 72 hours of C1D1
		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --		  	ONC NURSING COMMUNICATION 6	Interval: Once	Occurrences: --	Comments:	Collect research labs based on draw order
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Bone Turnover Makers (BAP and CTX): Blood; serum.
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.				Day 15	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.					
Cycle 4	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 8	Interval: Once	Occurrences: --	Comments:	Document KPS and physical examination
		  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
		  	ONC PROVIDER COMMUNICATION 12	Interval: Once	Occurrences: --	Comments:	Confirm PFTs ordered  (D1 of cycles 2-6)
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	LIPID PANEL	Interval: Once	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: Once	Occurrences: --	Comments:	For women of child-bearing potential; must be done within 72 hours of C1D1
		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --		  	ONC NURSING COMMUNICATION 6	Interval: Once	Occurrences: --	Comments:	Collect research labs based on draw order
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	PK/ADA Sampling (PRE-INFUSION): Blood; plasma. 
Collect PRE-infusion, fill tube completely and GENTLY mix (without shaking to avoid hemolysis) by slowly inverting the collection tube 6-8 times. If an indwelling catheter is used, saline must be used to keep the cannula patient, and the first 1mL of blood from each sampling will be discarded. Place the collection tube in an ice bath or crushed ice. Ice blocks are acceptable, but icy water must surround the samples
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Serum Biomarkers: Blood; serum.
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Whole Blood PBMCs
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.				Day 15	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.					
Cycle 5	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 8	Interval: Once	Occurrences: --	Comments:	Document KPS and physical examination
		  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
		  	ONC PROVIDER COMMUNICATION 12	Interval: Once	Occurrences: --	Comments:	Confirm PFTs ordered  (D1 of cycles 2-6)
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	LIPID PANEL	Interval: Once	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: Once	Occurrences: --	Comments:	For women of child-bearing potential; must be done within 72 hours of C1D1
		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --		  	ONC NURSING COMMUNICATION 6	Interval: Once	Occurrences: --	Comments:	Collect research labs based on draw order
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.				Day 15	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.					
Cycle 6	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 8	Interval: Once	Occurrences: --	Comments:	Document KPS and physical examination
		  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
		  	ONC PROVIDER COMMUNICATION 12	Interval: Once	Occurrences: --	Comments:	Confirm PFTs ordered  (D1 of cycles 2-6)
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	LIPID PANEL	Interval: Once	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: Once	Occurrences: --	Comments:	For women of child-bearing potential; must be done within 72 hours of C1D1
		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --		  	ONC NURSING COMMUNICATION 6	Interval: Once	Occurrences: --	Comments:	Collect research labs based on draw order
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Bone Turnover Makers (BAP and CTX): Blood; serum.
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	PK/ADA Sampling (PRE-INFUSION): Blood; plasma. 
Collect PRE-infusion, fill tube completely and GENTLY mix (without shaking to avoid hemolysis) by slowly inverting the collection tube 6-8 times. If an indwelling catheter is used, saline must be used to keep the cannula patient, and the first 1mL of blood from each sampling will be discarded. Place the collection tube in an ice bath or crushed ice. Ice blocks are acceptable, but icy water must surround the samples
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.				Day 15	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.					
Cycle 7	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 8	Interval: Once	Occurrences: --	Comments:	Document KPS and physical examination
		  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
		  	ONC PROVIDER COMMUNICATION 13	Interval: Once	Occurrences: --	Comments:	Confirm PFTs ordered (D1 of cycles 7, 9, 11, 13). After C13, check every 12 weeks.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	LIPID PANEL	Interval: Once	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: Once	Occurrences: --	Comments:	For women of child-bearing potential; must be done within 72 hours of C1D1
		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --		  	ONC NURSING COMMUNICATION 6	Interval: Once	Occurrences: --	Comments:	Collect research labs based on draw order
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.				Day 15	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.					
Cycle 8	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 8	Interval: Once	Occurrences: --	Comments:	Document KPS and physical examination
		  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10 (; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	LIPID PANEL	Interval: Once	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: Once	Occurrences: --	Comments:	For women of child-bearing potential; must be done within 72 hours of C1D1
		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --		  	ONC NURSING COMMUNICATION 6	Interval: Once	Occurrences: --	Comments:	Collect research labs based on draw order
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	PK/ADA Sampling (PRE-INFUSION): Blood; plasma. 
Collect PRE-infusion, fill tube completely and GENTLY mix (without shaking to avoid hemolysis) by slowly inverting the collection tube 6-8 times. If an indwelling catheter is used, saline must be used to keep the cannula patient, and the first 1mL of blood from each sampling will be discarded. Place the collection tube in an ice bath or crushed ice. Ice blocks are acceptable, but icy water must surround the samples
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.				Day 15	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.					
Cycle 9	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 8	Interval: Once	Occurrences: --	Comments:	Document KPS and physical examination
		  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
		  	ONC PROVIDER COMMUNICATION 13	Interval: Once	Occurrences: --	Comments:	Confirm PFTs ordered (D1 of cycles 7, 9, 11, 13). After C13, check every 12 weeks.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	LIPID PANEL	Interval: Once	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: Once	Occurrences: --	Comments:	For women of child-bearing potential; must be done within 72 hours of C1D1
		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --		  	ONC NURSING COMMUNICATION 6	Interval: Once	Occurrences: --	Comments:	Collect research labs based on draw order
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.				Day 15	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.					
Cycle 10	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 8	Interval: Once	Occurrences: --	Comments:	Document KPS and physical examination
		  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10 (; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	LIPID PANEL	Interval: Once	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: Once	Occurrences: --	Comments:	For women of child-bearing potential; must be done within 72 hours of C1D1
		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --		  	ONC NURSING COMMUNICATION 6	Interval: Once	Occurrences: --	Comments:	Collect research labs based on draw order
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.				Day 15	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.					
Cycle 11	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 8	Interval: Once	Occurrences: --	Comments:	Document KPS and physical examination
		  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
		  	ONC PROVIDER COMMUNICATION 13	Interval: Once	Occurrences: --	Comments:	Confirm PFTs ordered (D1 of cycles 7, 9, 11, 13). After C13, check every 12 weeks.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	LIPID PANEL	Interval: Once	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: Once	Occurrences: --	Comments:	For women of child-bearing potential; must be done within 72 hours of C1D1
		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --		  	ONC NURSING COMMUNICATION 6	Interval: Once	Occurrences: --	Comments:	Collect research labs based on draw order
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.				Day 15	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.					
Cycle 12	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 8	Interval: Once	Occurrences: --	Comments:	Document KPS and physical examination
		  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
		  	ONC PROVIDER COMMUNICATION 14	Interval: Once	Occurrences: --	Comments:	Provider communication: Order DEXA to be done yearly (based on date of baseline scan)
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	LIPID PANEL	Interval: Once	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: Once	Occurrences: --	Comments:	For women of child-bearing potential; must be done within 72 hours of C1D1
		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --		  	ONC NURSING COMMUNICATION 6	Interval: Once	Occurrences: --	Comments:	Collect research labs based on draw order
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	Bone Turnover Makers (BAP and CTX): Blood; serum.
			Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	PK/ADA Sampling (PRE-INFUSION): Blood; plasma. 
Collect PRE-infusion, fill tube completely and GENTLY mix (without shaking to avoid hemolysis) by slowly inverting the collection tube 6-8 times. If an indwelling catheter is used, saline must be used to keep the cannula patient, and the first 1mL of blood from each sampling will be discarded. Place the collection tube in an ice bath or crushed ice. Ice blocks are acceptable, but icy water must surround the samples
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.				Day 15	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.					
Cycle 13	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 8	Interval: Once	Occurrences: --	Comments:	Document KPS and physical examination
		  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
		  	ONC PROVIDER COMMUNICATION 13	Interval: Once	Occurrences: --	Comments:	Confirm PFTs ordered (D1 of cycles 7, 9, 11, 13). After C13, check every 12 weeks.
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	LIPID PANEL	Interval: Once	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: Once	Occurrences: --	Comments:	For women of child-bearing potential; must be done within 72 hours of C1D1
		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --		  	ONC NURSING COMMUNICATION 6	Interval: Once	Occurrences: --	Comments:	Collect research labs based on draw order
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.				Day 15	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.					
Cycles 14,15	Repeat 2 times	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 8	Interval: Once	Occurrences: --	Comments:	Document KPS and physical examination
		  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10 (; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	LIPID PANEL	Interval: Once	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: Once	Occurrences: --	Comments:	For women of child-bearing potential; must be done within 72 hours of C1D1
		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --		  	ONC NURSING COMMUNICATION 6	Interval: Once	Occurrences: --	Comments:	Collect research labs based on draw order
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.				Day 15	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.					
Cycle 16	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 8	Interval: Once	Occurrences: --	Comments:	Document KPS and physical examination
		  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10 (; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	LIPID PANEL	Interval: Once	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: Once	Occurrences: --	Comments:	For women of child-bearing potential; must be done within 72 hours of C1D1
		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --		  	ONC NURSING COMMUNICATION 6	Interval: Once	Occurrences: --	Comments:	Collect research labs based on draw order
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	PK/ADA Sampling (PRE-INFUSION): Blood; plasma. 
Collect PRE-infusion, fill tube completely and GENTLY mix (without shaking to avoid hemolysis) by slowly inverting the collection tube 6-8 times. If an indwelling catheter is used, saline must be used to keep the cannula patient, and the first 1mL of blood from each sampling will be discarded. Place the collection tube in an ice bath or crushed ice. Ice blocks are acceptable, but icy water must surround the samples
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.				Day 15	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.					
Cycles 17 to 19	Repeat 3 times	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 8	Interval: Once	Occurrences: --	Comments:	Document KPS and physical examination
		  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10 (; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	LIPID PANEL	Interval: Once	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: Once	Occurrences: --	Comments:	For women of child-bearing potential; must be done within 72 hours of C1D1
		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --		  	ONC NURSING COMMUNICATION 6	Interval: Once	Occurrences: --	Comments:	Collect research labs based on draw order
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.				Day 15	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.					
Cycle 20	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 8	Interval: Once	Occurrences: --	Comments:	Document KPS and physical examination
		  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10 (; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	LIPID PANEL	Interval: Once	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: Once	Occurrences: --	Comments:	For women of child-bearing potential; must be done within 72 hours of C1D1
		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --		  	ONC NURSING COMMUNICATION 6	Interval: Once	Occurrences: --	Comments:	Collect research labs based on draw order
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	PK/ADA Sampling (PRE-INFUSION): Blood; plasma. 
Collect PRE-infusion, fill tube completely and GENTLY mix (without shaking to avoid hemolysis) by slowly inverting the collection tube 6-8 times. If an indwelling catheter is used, saline must be used to keep the cannula patient, and the first 1mL of blood from each sampling will be discarded. Place the collection tube in an ice bath or crushed ice. Ice blocks are acceptable, but icy water must surround the samples
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.				Day 15	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.					
Cycles 21 to 23	Repeat 3 times	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 8	Interval: Once	Occurrences: --	Comments:	Document KPS and physical examination
		  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10 (; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	LIPID PANEL	Interval: Once	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: Once	Occurrences: --	Comments:	For women of child-bearing potential; must be done within 72 hours of C1D1
		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --		  	ONC NURSING COMMUNICATION 6	Interval: Once	Occurrences: --	Comments:	Collect research labs based on draw order
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.				Day 15	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.					
Cycle 24	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 8	Interval: Once	Occurrences: --	Comments:	Document KPS and physical examination
		  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
		  	ONC PROVIDER COMMUNICATION 14	Interval: Once	Occurrences: --	Comments:	Provider communication: Order DEXA to be done yearly (based on date of baseline scan)
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	LIPID PANEL	Interval: Once	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: Once	Occurrences: --	Comments:	For women of child-bearing potential; must be done within 72 hours of C1D1
		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --		  	ONC NURSING COMMUNICATION 6	Interval: Once	Occurrences: --	Comments:	Collect research labs based on draw order
			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre Infusion Lab
  	RESEARCH STUDY SPECIMEN	Interval: Once	Occurrences: --	Comments:	PK/ADA Sampling (PRE-INFUSION): Blood; plasma. 
Collect PRE-infusion, fill tube completely and GENTLY mix (without shaking to avoid hemolysis) by slowly inverting the collection tube 6-8 times. If an indwelling catheter is used, saline must be used to keep the cannula patient, and the first 1mL of blood from each sampling will be discarded. Place the collection tube in an ice bath or crushed ice. Ice blocks are acceptable, but icy water must surround the samples
			Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.				Day 15	Perform every 1 day x1			Research tolerance: -4/+4 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: Once	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	OK TO USE	Interval: Once	Occurrences: --			Line Care
  	INSERT PERIPHERAL IV OR ACCESS PORTACATH	Interval: Until discontinued	Occurrences: --		  	sodium chloride 0.9% flush 10 mL	Dose: 10 mL	Route: intravenous	PRN for 10 doses	Start: S				  	sodium chloride 0.9% infusion 250 mL	Dose: 250 mL	Route: intravenous	PRN @ 30 mL/hr	Start: S					Pre-Medications
  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30-60 before Axatilimab			Medications
  	INV-Axatilimab/Placebo (INCA34176-357/H-56778/Hill) 0.3 mg/kg in sodium chloride 0.9% 50 mL infusion	Dose: 0.3 mg/kg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Bag may contain axatilimab or placebo. Infuse IV over 30 minutes (allowed infusion time is 25-40 minutes) using a 0.2 micron inline filter. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-AXATILIMAB/PLACEBO 50 MG/ML INTRAVENOUS SOLN (INCA34176-357/H-56778/HILL)	Medications	0.3 mg/kg	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	50 mL	Yes	Yes				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.					
EOT	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1			Research tolerance: -0/+0 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Document KPS and physical examination
		  	ONC PROVIDER COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Document cGVHD scoring (organ and overall severity score of 0 to 10; see Appendix E). Scoring performed on Day 1 will be the baseline for cGVHD response assessment.
		  	ONC PROVIDER COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Document corticosteroid dose (and any changes in dose if occurred between visits)
		  	ONC PROVIDER COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Document any Adverse Events (AEs)  regardless of the assumption of a causal relationship with the study treatment(s). AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis whenever possible rather than by individual underlying signs and symptoms
		  	ONC PROVIDER COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Any new cGVHD therapy should be documented
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	LIPID PANEL	Interval: --	Occurrences: --		  	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For women of child-bearing potential; must be done within 72 hours of C1D1
		  	CYTOMEGALOVIRUS, QUANTITATIVE PCR	Interval: --	Occurrences: --			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	MEASURE WEIGHT	Interval: --	Occurrences: --		  	OK TO USE	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Bone Turnover Makers (BAP and CTX)
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	PK/ADA Sampling: Blood; plasma. 
Fill tube completely and GENTLY mix (without shaking to avoid hemolysis) by slowly inverting the collection tube 6-8 times. If an indwelling catheter is used, saline must be used to keep the cannula patient, and the first 1mL of blood from each sampling will be discarded. Place the collection tube in an ice bath or crushed ice. Ice blocks are acceptable, but icy water must surround the samples
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Serum Biomarkers: Blood; serum.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Whole Blood PBMCs