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IP/OP RESEARCH PRO00038368 KYV101-006 TREATMENT SHROFF	

Types:      Research Oncology Treatment
Synonyms:  

Cycle 1	Repeat 1 time	Cycle length: 736 days	Day -5	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Criteria prior to LD
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Physical Exams to be performed on days -5 to -3.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed on days -5 to -3. On day -5, weight patient prior to 1st dose.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed on days -5 to -3.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	To be performed on days -5 to -3. On day -5, perform prior to 1st dose.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Continuous Collections of AEs
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Hydration
  	sodium chloride 0.9 % infusion	Dose: 150 mL/hr	Route: intravenous	once over 6 Hours for 1 dose	Start: S			Instructions:	On days -5.
Start 1 hour prior to chemotherapy. 			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	On days -5. 
Administer 30 to 60 minutes before infusion.		  	fosaprepitant (EMEND) IVPB 150 mg	Dose: 150 mg	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	On days -5. 
Administer 30 to 60 minutes before infusion.		  	LORAZepam (ATIVAN) tablet 0.5 mg	Dose: 0.5 mg	Route: oral	once for 1 dose			Offset: 30 Minutes	Instructions:	On days -5. 
Administer 30 to 60 minutes before infusion.			Chemotherapy
  	INV-cycloPHOSphamide (KYV101-006/Pro00038368/Shroff) 300 mg/m2, INV-mesna (KYV101-006/Pro00038368/Shroff) 300 mg/m2 in dextrose 5% 250 mL chemo IVPB	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Instructions:	On days -5 	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-CYCLOPHOSPHAMIDE 1 GRAM IV POWDER FOR SOLN (KYV101-006/PRO00038368/SHROFF)	Medications	300 mg/m2	Yes	Yes	INV-MESNA 100 MG/ML INTRAVENOUS SOLN (KYV101-006/PRO00038368/SHROFF)	Medications	300 mg/m2	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes			  	INV-fludarabine (KYV101-006/Pro00038368/Shroff) 30 mg/m2 in sodium chloride 0.9% 100 mL chemo IVPB	Dose: 30 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 2.5 Hours	Instructions:	On days -5 	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-FLUDARABINE 50 MG/2 ML INTRAVENOUS SOLN (KYV101-006/PRO00038368/SHROFF)	Medications	30 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day -4	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Criteria prior to LD
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Physical Exams to be performed on days -5 to -3.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed on days -5 to -3. On day -5, weight patient prior to 1st dose.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed on days -5 to -3.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	To be performed on days -5 to -3. On day -5, perform prior to 1st dose.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Continuous Collections of AEs
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Hydration
  	sodium chloride 0.9 % infusion	Dose: 150 mL/hr	Route: intravenous	once over 6 Hours for 1 dose	Start: S			Instructions:	On days -4.
Start 1 hour prior to chemotherapy. 			Pre-Medications
  	LORAZepam (ATIVAN) tablet 0.5 mg	Dose: 0.5 mg	Route: oral	once for 1 dose			Offset: 30 Minutes	Instructions:	On days -4. 
Administer 30 to 60 minutes before infusion.			Chemotherapy
  	INV-cycloPHOSphamide (KYV101-006/Pro00038368/Shroff) 300 mg/m2, INV-mesna (KYV101-006/Pro00038368/Shroff) 300 mg/m2 in dextrose 5% 250 mL chemo IVPB	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Instructions:	On days -4. 	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-CYCLOPHOSPHAMIDE 1 GRAM IV POWDER FOR SOLN (KYV101-006/PRO00038368/SHROFF)	Medications	300 mg/m2	Yes	Yes	INV-MESNA 100 MG/ML INTRAVENOUS SOLN (KYV101-006/PRO00038368/SHROFF)	Medications	300 mg/m2	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes			  	INV-fludarabine (KYV101-006/Pro00038368/Shroff) 30 mg/m2 in sodium chloride 0.9% 100 mL chemo IVPB	Dose: 30 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 2.5 Hours	Instructions:	On days -4. 	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-FLUDARABINE 50 MG/2 ML INTRAVENOUS SOLN (KYV101-006/PRO00038368/SHROFF)	Medications	30 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day -3	Perform every 1 day x1			Research tolerance: -0/+0 days	Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Criteria prior to LD
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Physical Exams to be performed on days -5 to -3.
		  	MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed on days -5 to -3. On day -5, weight patient prior to 1st dose.
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed on days -5 to -3.
		  	PULSE OXIMETRY	Interval: --	Occurrences: --	Comments:	To be performed on days -5 to -3. On day -5, perform prior to 1st dose.
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Continuous Collections of AEs
			Line Care
  	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Hydration
  	sodium chloride 0.9 % infusion	Dose: 150 mL/hr	Route: intravenous	once over 6 Hours for 1 dose	Start: S			Instructions:	On days -3.
Start 1 hour prior to chemotherapy. 			Pre-Medications
  	palonosetron (ALOXI) injection 0.25 mg	Dose: 0.25 mg	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	On days -3.
Administer 30 to 60 minutes before infusion.		  	LORAZepam (ATIVAN) tablet 0.5 mg	Dose: 0.5 mg	Route: oral	once for 1 dose			Offset: 30 Minutes	Instructions:	On days -3. 
Administer 30 to 60 minutes before infusion.			Chemotherapy
  	INV-cycloPHOSphamide (KYV101-006/Pro00038368/Shroff) 300 mg/m2, INV-mesna (KYV101-006/Pro00038368/Shroff) 300 mg/m2 in dextrose 5% 250 mL chemo IVPB	Dose: --	Route: intravenous	once over 2 Hours for 1 dose			Offset: 30 Minutes	Instructions:	On days -3. 	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-CYCLOPHOSPHAMIDE 1 GRAM IV POWDER FOR SOLN (KYV101-006/PRO00038368/SHROFF)	Medications	300 mg/m2	Yes	Yes	INV-MESNA 100 MG/ML INTRAVENOUS SOLN (KYV101-006/PRO00038368/SHROFF)	Medications	300 mg/m2	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes			  	INV-fludarabine (KYV101-006/Pro00038368/Shroff) 30 mg/m2 in sodium chloride 0.9% 100 mL chemo IVPB	Dose: 30 mg/m2	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 2.5 Hours	Instructions:	On days -3. 	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-FLUDARABINE 50 MG/2 ML INTRAVENOUS SOLN (KYV101-006/PRO00038368/SHROFF)	Medications	30 mg/m2	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	100 mL	Yes	Yes				Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: --	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: --	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once PRN	Start: S				  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN					  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S					Discharge Nursing Orders
☑	sodium chloride 0.9 % flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine (PF) injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.			Discharge Nursing Orders
  	alteplase (CATHFLO) for NON Quinton and NON Hemodialysis Catheters 2 mg	Dose: 2 mg	Route: intra-catheter	once PRN	Start: S			Instructions:	HOLD and notify provider if Platelets LESS than 50.  Instill dose into occluded catheter. Do not force solution into
catheter. After a 30-minute dwell time, assess catheter function by attempting
to aspirate blood. If catheter is functional, aspirate 4 to 5 mL of blood in
patients greater than or equal to 10 kg to remove Cathflo Activase and
residual clots. Gently irrigate the catheter with NS. If catheter remains
nonfunctional, let Cathflo Activase dwell for another 90 minutes (total dwell
time: 120 minutes) and reassess function. If catheter function is not restored,
a second dose may be instilled				Day 0	Perform every 1 day x1			Research tolerance: -0/+0 days	Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: Once	Occurrences: --	Comments:	For potential safety risks with KYV-101 and mitigation strategies, transfusions will be given for Hgb <7 g/dL and for platelets <10 per microliter. Please order blood as appropriate.
		  	ONC PROVIDER COMMUNICATION 3	Interval: Once	Occurrences: --	Comments:	Dependent on EA/SAE/ICANS, please order either Methylprednisolone 1 mg/kg IV x2 Daily or equivalent dexamethasone, or Methylprednisolone 1,000 mg IV per day for 3 days per investigator discretion.
		  	ONC PROVIDER COMMUNICATION 4	Interval: Once	Occurrences: --	Comments:	For CRS Management, refer to Table 3. Recommendations for the Management of Cytokine Release Syndrome for details. 
o Administer tocilizumabb 8 mg/kg IV over 1 hour (not to exceed 800 mg). Please order as needed. 
o Repeat tocilizumab every 8 hours as needed if not responsive to IV fluids or increasing supplemental oxygen. 
o Limit to a maximum of 3 doses in a 24-hour period; maximum total of 4 doses.
			Nursing Orders
  	ONC NURSING COMMUNICATION 25	Interval: Once	Occurrences: --	Comments:	Criteria prior to KYV-101 infusion
		  	ONC NURSING COMMUNICATION 8	Interval: Once	Occurrences: --	Comments:	Physical Exams
		  	MEASURE WEIGHT	Interval: Once	Occurrences: --		  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --		  	PULSE OXIMETRY	Interval: Once	Occurrences: --		  	ECG 12-LEAD	Interval: Once	Occurrences: --		  	ONC NURSING COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	Continuous Collections of Aes
		  	ONC NURSING COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	ICE test: If subject is arousable and able to perform Mental Status assessment, the following domains should be tested: orientation, naming, following commands, writing, and attention (ICE-Tool).
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	GGT	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	URIC ACID LEVEL	Interval: Once	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --		  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: Once	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: Once	Occurrences: --		  	FERRITIN LEVEL	Interval: Once	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --	Comments:	As clinically indicated only
		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: Once	Occurrences: --	Comments:	As clinically indicated only
		  	FIBRINOGEN	Interval: Once	Occurrences: --	Comments:	As clinically indicated only
		  	D-DIMER	Interval: Once	Occurrences: --	Comments:	As clinically indicated only
		  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: Once	Occurrences: --		  	IMMUNOGLOBULIN G	Interval: Once	Occurrences: --		  	IMMUNOGLOBULIN A	Interval: Once	Occurrences: --		  	IMMUNOGLOBULIN M	Interval: Once	Occurrences: --			Medications
  	fluconazole (DIFLUCAN) tablet 400 mg	Dose: 400 mg	Route: oral	daily	Start: S				  	acyclovir (ZOVIRAX) tablet 400 mg	Dose: 400 mg	Route: oral	2 times daily	Start: S				  	sulfamethoxazole-trimethoprim (BACTRIM SS) 400-80 mg per tablet 1 tablet	Dose: 1 tablet	Route: oral	daily	Start: S					Line Care
  	sodium chloride 0.9 % infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open.			Pre-Medications
  	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before KYV-101		  	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose	Start: S			Instructions:	Administer 30 minutes before KYV-101			Medications
  	dexAMETHasone (DECADRON) IV 10 mg	Dose: 10 mg	Route: intravenous	every 24 hours for 3 doses	Start: S			Instructions:	To be given on day 0, 1, and 2.			CAR-T Infusion
  	INV-KYV-101 CAR-T cell infusion (KYV-101-006/Pro00038368/Shroff) 1 Bag	Dose: 1 Bag	Route: intravenous	once over 20 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	IV bag contains between 10mL and 70mL with 1 x 10^8 CAR-T cells.  Infuse via gravity feed with no filter. Flush the line with NS by adding 30mL of NS to the bag. 
Caution: New Drug-Limited by Federal (USA) Law to Investigational use.			Hematology & Oncology Hypersensitivity Reaction Standing Order
  	ONC NURSING COMMUNICATION 82	Interval: Until discontinued	Occurrences: --	Comments:	Grade 1 - MILD Symptoms (cutaneous and subcutaneous symptoms only - itching, flushing, periorbital edema, rash, or runny nose)
1. Stop the infusion.
2. Place the patient on continuous monitoring.
3. Obtain vital signs.
4. Administer Normal Saline at 50 mL per hour using a new bag and new intravenous tubing.
5. If greater than or equal to 30 minutes since the last dose of Diphenhydramine, administer Diphenhydramine 25 mg intravenous once.
6. If less than 30 minutes since the last dose of Diphenhydramine, administer Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
7. Notify the treating physician.
8. If no improvement after 15 minutes, advance level of care to Grade 2 (Moderate) or Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 83	Interval: Until discontinued	Occurrences: --	Comments:	Grade 2 - MODERATE Symptoms (cardiovascular, respiratory, or gastrointestinal symptoms - shortness of breath, wheezing, nausea, vomiting, dizziness, diaphoresis, throat or chest tightness, abdominal or back pain)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
6. Administer Normal Saline at 150 mL per hour using a new bag and new intravenous tubing.
7. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous), Cetirizine 10 mg orally and Famotidine 20 mg intravenous once.
8. If no improvement after 15 minutes, advance level of care to Grade 3 (Severe).
9. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	ONC NURSING COMMUNICATION 4	Interval: Until discontinued	Occurrences: --	Comments:	Grade 3 – SEVERE Symptoms (hypoxia, hypotension, or neurologic compromise – cyanosis or O2 saturation less than 92%, hypotension with systolic blood pressure less than 90 mmHg, confusion, collapse, loss of consciousness, or incontinence)
1. Stop the infusion.
2. Notify the CERT team and treating physician immediately.
3. Place the patient on continuous monitoring.
4. Obtain vital signs.
5. If heart rate is less than 50 or greater than 120, or blood pressure is less than 90/50 mmHg, place patient in reclined or flattened position.
6. Administer Oxygen at 2 L per minute via nasal cannula. Titrate to maintain O2 saturation of greater than or equal to 92%.
7. Administer Normal Saline at 1000 mL intravenous bolus using a new bag and new intravenous tubing.
8. Administer Hydrocortisone 100 mg intravenous (if patient has allergy to Hydrocortisone, please administer Dexamethasone 4 mg intravenous) and Famotidine 20 mg intravenous once.
9. Administer Epinephrine (1:1000) 0.3 mg subcutaneous.
10. Assess vital signs every 15 minutes until resolution of symptoms or otherwise ordered by covering physician.
		  	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	PRN	Start: S				  	cetirizine (ZyrTEC) tablet 10 mg	Dose: 10 mg	Route: oral	once PRN	Start: S				  	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	PRN	Start: S				  	hydrocortisone sodium succinate (Solu-CORTEF) injection 100 mg	Dose: 100 mg	Route: intravenous	PRN					  	dexAMETHasone (DECADRON) IV 4 mg	Dose: 4 mg	Route: intravenous	PRN	Start: S				  	epINEPHrine (ADRENALIN) 1 mg/1 mL injection 0.3 mg	Dose: 0.3 mg	Route: subcutaneous	PRN	Start: S