Protocol Index	

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IP/OP RSH PRO00038180 EFSTATHIOU JANX007 STEP DOSE SCHEDULE B	

Types:      Research Oncology Treatment
Synonyms:  JANX007, PROSTATE, PRO00038180

Screening (Day –28 to Day –1)	Repeat 1 time	Cycle length: 28 days	Day -28	Perform every 1 day x1		Treatment Conditions - Research
  	TREATMENT CONDITIONS 37	Interval: --	Occurrences: --	Comments:	After consenting, subjects must meet the following parameters:
·        Histologically or cytologically confirmed adenocarcinoma of the prostate
·        Serum testosterone <50ng/d: achieved by orchiectomy or ongoing luteinizing hormone-releasing hormone within 28 days prior to the start of study drug
·        PSA progression: PSA level >=1ng/ml that has increased on at least 2 successive occasions at least 1 week apart
·        ANC>=1500/mm³or >=1.5X10/L
·        HGB >=9d/dL
·        PLT >=75,000/mm³
·        GFR >=45mL/min
·        Total serum bilirubin <=1.5XULN
·        AST and ALT <=2.5XULN
·        Serum albumin >=30ng/mL
·        Resting O2 >=92% ORA
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Physical examination
to be performed by Principal Investigator or Sub-Investigator
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	ECOG Performance status
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	12 lead EKG
			Cardiology
  	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --			Labs
  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	HEMATOLOGY & CHEMISTRY  MUST BE OBTAINED WITHIN 14 DAYS PRIOR TO CYCLE 1 DAY 1
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	FERRITIN LEVEL	Interval: --	Occurrences: --		  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --		  	TESTOSTERONE, TOTAL AND FREE, IMMUNOASSAY AND CALCULATION (FOR ADULT MALES)	Interval: --	Occurrences: --		  	URINALYSIS SCREEN AND MICROSCOPY, WITH REFLEX TO CULTURE	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --		  	HEPATITIS C VIRUS (HCV) ANTIBODY WITH REFLEX TO PCR	Interval: --	Occurrences: --		  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --		  	D-DIMER	Interval: --	Occurrences: --		  	EPSTEIN-BARR VIRUS (EBV), QUANTITATIVE PCR	Interval: --	Occurrences: --		  	CYTOMEGALOVIRUS BY PCR	Interval: --	Occurrences: --		  	TESTOSTERONE, TOTAL, IMMUNOASSAY (FOR ADULT MALES)	Interval: --	Occurrences: --			Nursing Orders
  	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	FOR NEUROLOGICAL DEFICITS ONLY
		  	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	FOR NEUROLOGICAL DEFICITS ONLY
			Imaging
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	PSMA-PET and Optional FDG-PET
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Tumor Assessment
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	COVID-19 Optional Vaccination 
Subjects are encouraged to get the COVID-19 vaccination/booster >2 weeks prior to JANX007 treatment initiation. Vaccination efficacy on-study is unknown; however, COVID-19 vaccination would be allowed on study, after clearance of the first cycle, and with a 2-week dose hold.
					
IP Cycle 1	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Physical examination
		  	VITAL SIGNS - T/P/R/BP	Interval: As needed	Occurrences: --	Comments:	1. Pre-infusion vitals should be collected up to 30 minutes prior to infusion without pre-hydration requirements.
2. Pre-infusion vitals should be obtained prior to starting pre-hydration and after completion of hydration and prior to infusion.
3. Vital signs to be collected every 30 minutes (+/-10 minute window) during the infusion and all other timepoints. 
4. Take Vital Signs at End of Infusion (+10 min window)
5. Take Vital Signs 2-hr post end of infusion (+/- 20 min window)
6. Take Vital Signs 6-hr post end of infusion (+/- 1 hr window)
		  	ONC NURSING COMMUNICATION 10	Interval: Until discontinued	Occurrences: --	Comments:	ECOG Performance status
			Nursing Orders
  	ECG 12-LEAD	Interval: Once	Occurrences: --	Comments:	Pre-Infusion ECG 12 Lead Order

Clinical Indications: Rate/Rhythm
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: Until discontinued	Occurrences: --	Comments:	Research coordinators will draw research labs independently. Inpatient nurses please draw pre-infusion labs.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --	Comments:	Pre-Infusion/Pre-hydration
		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --	Comments:	Pre-Infusion/Pre-hydration
		  	FERRITIN LEVEL	Interval: Once	Occurrences: --	Comments:	Pre-Infusion/Pre-hydration
		  	AMYLASE LEVEL	Interval: Once	Occurrences: --	Comments:	Pre-Infusion/Pre-hydration
		  	LIPASE LEVEL	Interval: Once	Occurrences: --	Comments:	Pre-Infusion/Pre-hydration
		  	TRYPTASE	Interval: Once	Occurrences: --	Comments:	Pre-Infusion/Pre-hydration
		  	LACTIC ACID LEVEL	Interval: Once	Occurrences: --	Comments:	Pre-Infusion/Pre-hydration
		  	C-REACTIVE PROTEIN	Interval: Once	Occurrences: --	Comments:	Pre-Infusion/Pre-hydration
		  	LDH	Interval: Once	Occurrences: --	Comments:	Pre-Infusion/Pre-hydration
		  	URIC ACID LEVEL	Interval: Once	Occurrences: --	Comments:	Pre-Infusion/Pre-hydration
		  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --	Comments:	Pre-Infusion/Pre-hydration
		  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --	Comments:	Pre-Infusion/Pre-hydration
		  	D-DIMER	Interval: Once	Occurrences: --	Comments:	Pre-Infusion/Pre-hydration
		  	BILIRUBIN DIRECT	Interval: Once	Occurrences: --	Comments:	Pre-Infusion/Pre-hydration
		  	PROSTATE SPECIFIC ANTIGEN	Interval: Once	Occurrences: --	Comments:	Pre-Infusion/Pre-hydration
		  	URINALYSIS SCREEN AND MICROSCOPY, WITH REFLEX TO CULTURE	Interval: Once	Occurrences: --	Comments:	Pre-Infusion/Pre-hydration
			Labs
  	COVID-19 QUALITATIVE RT-PCR	Interval: Once	Occurrences: --	Comments:	NOTE: SARS-CoV2 negative up to 3 days prior to first infusion. Both antigen and PCR test are acceptable per institutional practice.
		  	ANTI-SARS-COV-2 TOTAL	Interval: Once	Occurrences: --	Comments:	NOTE: SARS-CoV2 negative up to 3 days prior to first infusion. Both antigen and PCR test are acceptable per institutional practice.
			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	AE/SAE Assessment
		  	ONC NURSING COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Concomitant Medications
			Nursing Orders
  	INSERT PERIPHERAL IV	Interval: Once	Occurrences: --	Comments:	Insert Peripheral IV x 2.

Research patient requires 1 peripheral IV on each arm, one for drug and one for blood draw. Ultra-sound guided for insertion assistance may be used.
			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.			Chemotherapy
  	INV-JANX007 in 0.9% NaCl Infusion (PSMA-007-001/Pro00038180/Efstathiou)	Dose: --	Route: intravenous	once for 1 dose	Start: S			Instructions:	Prepared bag or syringe contains JANX007 in NS. Administer IV through peripheral line via 0.2 micron inline filter. Infuse over 2 hours (+/- 15 min) for Cycle 1, then subsequent doses may be reduced by up to 30 minutes to minimum infusion time of 30 minutes. Prepared bag or syringe is stable 4 hours at room temp. 
For syringe, DO NOT FLUSH.
Caution: New Drug - Limited by federal (USA) Law to investigational use.  HAZARDOUS - handle with care.			Nursing Orders
  	ECG 12-LEAD	Interval: Once	Occurrences: --	Comments:	Post-Infusion ECG 12 Lead Order

Clinical Indications: Rate/Rhythm
			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					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 2	Perform every 1 day x1		Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --		  	URIC ACID LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	FERRITIN LEVEL	Interval: Once	Occurrences: --		  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --		  	LACTIC ACID LEVEL	Interval: Once	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: Once	Occurrences: --		  	D-DIMER	Interval: Once	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: Once	Occurrences: --		  	PROSTATE SPECIFIC ANTIGEN	Interval: Once	Occurrences: --		  	URINALYSIS SCREEN AND MICROSCOPY, WITH REFLEX TO CULTURE	Interval: Once	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	AE/SAE Assessment
		  	ONC NURSING COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Concomitant Medications
				Day 3	Perform every 1 day x1		Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: Once	Occurrences: --		  	FERRITIN LEVEL	Interval: Once	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --		  	URIC ACID LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	D-DIMER	Interval: Once	Occurrences: --		  	TOTAL BILIRUBIN	Interval: Once	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	AE/SAE Assessment
		  	ONC NURSING COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Concomitant Medications
				Day 4	Perform every 1 day x1		Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --	Comments:	Pre-Infusion/Pre-hydration
		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --	Comments:	Pre-Infusion/Pre-hydration
		  	LDH	Interval: Once	Occurrences: --	Comments:	Pre-Infusion/Pre-hydration
		  	URIC ACID LEVEL	Interval: Once	Occurrences: --	Comments:	Pre-Infusion/Pre-hydration
		  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --	Comments:	Pre-Infusion/Pre-hydration
		  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --	Comments:	Pre-Infusion/Pre-hydration
		  	BILIRUBIN DIRECT	Interval: Once	Occurrences: --	Comments:	Pre-Infusion/Pre-hydration
			Labs
  	URINALYSIS SCREEN AND MICROSCOPY, WITH REFLEX TO CULTURE	Interval: Once	Occurrences: --				Day 5	Perform every 1 day x1		Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --			Labs
  	URINALYSIS SCREEN AND MICROSCOPY, WITH REFLEX TO CULTURE	Interval: Once	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	AE/SAE Assessment
		  	ONC NURSING COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Concomitant Medications
				Day 8	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Physical examination
		  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --	Comments:	1. Pre-infusion vitals should be collected up to 30 minutes prior to infusion without pre-hydration requirements
2. Pre-infusion vitals should be obtained prior to starting pre-hydration and after completion of hydration and prior to infusion
3. Vital signs to be collected every 30 minutes (+/-10 minute window) during the infusion and all other timepoints. 
4. Take Vital Signs at End of Infusion (+10 min window)
5. Take Vital Signs 2-hr post end of infusion (+/- 20 min window)
6. Take Vital Signs 6-hr post end of infusion (+/- 1 hr window)
			Nursing Orders
  	ECG 12-LEAD	Interval: Once	Occurrences: --	Comments:	Pre-Infusion ECG 12 Lead Order

Clinical Indications: Rate/Rhythm
			Nursing Orders
  	ONC NURSING COMMUNICATION 30	Interval: Until discontinued	Occurrences: --	Comments:	Research coordinators will draw research labs independently. Inpatient nurses please draw pre-infusion labs.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: Once	Occurrences: --		  	FERRITIN LEVEL	Interval: Once	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --		  	URIC ACID LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	D-DIMER	Interval: Once	Occurrences: --		  	TOTAL BILIRUBIN	Interval: Once	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: Once	Occurrences: --			Labs
  	URINALYSIS SCREEN AND MICROSCOPY, WITH REFLEX TO CULTURE	Interval: Once	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	AE/SAE Assessment
		  	ONC NURSING COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Concomitant Medications
			Nursing Orders
  	INSERT PERIPHERAL IV	Interval: Once	Occurrences: --	Comments:	Insert Peripheral IV x 2.

Research patient requires 1 peripheral IV on each arm, one for drug and one for blood draw. Ultra-sound guided for insertion assistance may be used.
			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.			Chemotherapy
  	INV-JANX007 in 0.9% NaCl Infusion (PSMA-007-001/Pro00038180/Efstathiou)	Dose: --	Route: intravenous	once for 1 dose	Start: S			Instructions:	Prepared bag or syringe contains JANX007 in NS. Administer IV through peripheral line via 0.2 micron inline filter. Infuse over 2 hours (+/- 15 min) for Cycle 1, then subsequent doses may be reduced by up to 30 minutes to minimum infusion time of 30 minutes. Prepared bag or syringe is stable 4 hours at room temp. 
For syringe, DO NOT FLUSH.
Caution: New Drug - Limited by federal (USA) Law to investigational use.  HAZARDOUS - handle with care.			Nursing Orders
  	ECG 12-LEAD	Interval: Once	Occurrences: --	Comments:	Post-Infusion ECG 12 Lead Order

Clinical Indications: Rate/Rhythm
			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					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 9	Perform every 1 day x1		Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	FERRITIN LEVEL	Interval: Once	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: Once	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: Once	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --		  	URIC ACID LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	D-DIMER	Interval: Once	Occurrences: --		  	TOTAL BILIRUBIN	Interval: Once	Occurrences: --			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: Once	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	AE/SAE Assessment
		  	ONC NURSING COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Concomitant Medications
				Day 10	Perform every 1 day x1		Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	1. Pre-infusion vitals should be collected up to 30 minutes prior to infusion without pre-hydration requirements
2. Pre-infusion vitals should be obtained prior to starting pre-hydration and after completion of hydration and prior to infusion
3. Vital signs to be collected every 30 minutes (+/-10 minute window) during the infusion and all other timepoints. 
4. Take Vital Signs at End of Infusion (+10 min window)
5. Take Vital Signs 2-hr post end of infusion (+/- 20 min window)
6. Take Vital Signs 6-hr post end of infusion (+/- 1 hr window)
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --		  	URIC ACID LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	D-DIMER	Interval: Once	Occurrences: --		  	TOTAL BILIRUBIN	Interval: Once	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	AE/SAE Assessment
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Concomitant medications
				Day 12	Perform every 1 day x1		Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --		  	URIC ACID LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	TOTAL BILIRUBIN	Interval: Once	Occurrences: --			Labs
  	URINALYSIS SCREEN AND MICROSCOPY, WITH REFLEX TO CULTURE	Interval: Once	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	AE/SAE Assessment
		  	ONC NURSING COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Concomitant Medications
				Day 15	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: Until discontinued	Occurrences: --	Comments:	Physical examination
		  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --	Comments:	1. Pre-infusion vitals should be collected up to 30 minutes prior to infusion without pre-hydration requirements
2. Pre-infusion vitals should be obtained prior to starting pre-hydration and after completion of hydration and prior to infusion
3. Vital signs to be collected every 30 minutes (+/-10 minute window) during the infusion and all other timepoints. 
4. Take Vital Signs at End of Infusion (+10 min window)
5. Take Vital Signs 2-hr post end of infusion (+/- 20 min window)
6. Take Vital Signs 6-hr post end of infusion (+/- 1 hr window)
7. Take Vital Signs 10-hr post end of infusion (+/- 2 hr window)
			Nursing Orders
  	ECG 12-LEAD	Interval: Once	Occurrences: --	Comments:	Pre-Infusion ECG 12 Lead Order

Clinical Indications: Rate/Rhythm
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --	Comments:	Pre-Infusion/Pre-hydration
		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --	Comments:	Pre-Infusion/Pre-hydration
		  	C-REACTIVE PROTEIN	Interval: Once	Occurrences: --	Comments:	Pre-Infusion/Pre-hydration
		  	FERRITIN LEVEL	Interval: Once	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: Once	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --		  	URIC ACID LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	D-DIMER	Interval: Once	Occurrences: --		  	TOTAL BILIRUBIN	Interval: Once	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --			Labs
  	LACTIC ACID LEVEL	Interval: Once	Occurrences: --			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: Once	Occurrences: --			Labs
  	URINALYSIS SCREEN AND MICROSCOPY, WITH REFLEX TO CULTURE	Interval: Once	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	AE/SAE Assessment
		  	ONC NURSING COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Concomitant Medications
			Nursing Orders
  	INSERT PERIPHERAL IV	Interval: Once	Occurrences: --	Comments:	Insert Peripheral IV x 2.

Research patient requires 1 peripheral IV on each arm, one for drug and one for blood draw. Ultra-sound guided for insertion assistance may be used.
			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.			Chemotherapy
  	INV-JANX007 in 0.9% NaCl Infusion (PSMA-007-001/Pro00038180/Efstathiou)	Dose: --	Route: intravenous	once for 1 dose	Start: S			Instructions:	Prepared bag or syringe contains JANX007 in NS. Administer IV through peripheral line via 0.2 micron inline filter. Infuse over 2 hours (+/- 15 min) for Cycle 1, then subsequent doses may be reduced by up to 30 minutes to minimum infusion time of 30 minutes. Prepared bag or syringe is stable 4 hours at room temp. 
For syringe, DO NOT FLUSH.
Caution: New Drug - Limited by federal (USA) Law to investigational use.  HAZARDOUS - handle with care.			Nursing Orders
  	ECG 12-LEAD	Interval: Once	Occurrences: --	Comments:	Post-Infusion ECG 12 Lead Order

Clinical Indications: Rate/Rhythm
			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					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 16	Perform every 1 day x1		Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	FERRITIN LEVEL	Interval: Once	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: Once	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: Once	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --		  	URIC ACID LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	D-DIMER	Interval: Once	Occurrences: --		  	TOTAL BILIRUBIN	Interval: Once	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --			Labs
  	LACTIC ACID LEVEL	Interval: Once	Occurrences: --			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: Once	Occurrences: --			Labs
  	URINALYSIS SCREEN AND MICROSCOPY, WITH REFLEX TO CULTURE	Interval: Once	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 9	Interval: Once	Occurrences: --	Comments:	AE/SAE Assessment
		  	ONC NURSING COMMUNICATION 10	Interval: Once	Occurrences: --	Comments:	Concomitant Medications
				Day 17	Perform every 1 day x1		Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: Once	Occurrences: --		  	FERRITIN LEVEL	Interval: Once	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --		  	URIC ACID LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	D-DIMER	Interval: Once	Occurrences: --		  	TOTAL BILIRUBIN	Interval: Once	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: Once	Occurrences: --		  	LIPASE LEVEL	Interval: Once	Occurrences: --			Labs
  	LACTIC ACID LEVEL	Interval: Once	Occurrences: --			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: Once	Occurrences: --			Labs
  	URINALYSIS SCREEN AND MICROSCOPY, WITH REFLEX TO CULTURE	Interval: Once	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	AE/SAE Assessment
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Concomitant medications
				Day 18	Perform every 1 day x1		Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: Per unit protocol	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: Once	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: Once	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: Once	Occurrences: --		  	FERRITIN LEVEL	Interval: Once	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: Once	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: Once	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: Once	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: Once	Occurrences: --		  	URIC ACID LEVEL	Interval: Once	Occurrences: --		  	LDH	Interval: Once	Occurrences: --		  	D-DIMER	Interval: Once	Occurrences: --		  	TOTAL BILIRUBIN	Interval: Once	Occurrences: --			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: Once	Occurrences: --			Labs
  	URINALYSIS SCREEN AND MICROSCOPY, WITH REFLEX TO CULTURE	Interval: Once	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	AE/SAE Assessment
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Concomitant medications
					
OP Cycle 2	Repeat 1 time	Cycle length: 21 days	OP Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MISCELLANEOUS NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	ECOG Performance status
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	1. Pre-infusion vitals should be collected up to 30 minutes prior to infusion without pre-hydration requirements
2. Pre-infusion vitals should be obtained prior to starting pre-hydration and after completion of hydration and prior to infusion
3. Vital signs to be collected every 30 minutes (+/-10 minute window) during the infusion and all other timepoints. 
4. Take Vital Signs at End of Infusion (+10 min window)
5. Take Vital Signs 2-hr post end of infusion (+/- 20 min window)
6. Take Vital Signs 6-hr post end of infusion (+/- 1 hr window)
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	D-DIMER	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	FERRITIN LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --			Labs
  	CYTOMEGALOVIRUS BY PCR	Interval: --	Occurrences: --		  	EPSTEIN-BARR VIRUS (EBV), QUANTITATIVE PCR	Interval: --	Occurrences: --			Labs
  	URINALYSIS SCREEN AND MICROSCOPY, WITH REFLEX TO CULTURE	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	AE/SAE Assessment
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Concomitant medications
			Nursing Orders
  	INSERT PERIPHERAL IV	Interval: --	Occurrences: --	Comments:	Insert Peripheral IV x 2.
Research patient requires 1 peripheral IV on each arm, one for drug and one for blood draw. Ultra-sound guided for insertion assistance may be used.
			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.			Chemotherapy
  	INV-JANX007 in 0.9% NaCl Infusion (PSMA-007-001/Pro00038180/Efstathiou)	Dose: --	Route: intravenous	once for 1 dose	Start: S			Instructions:	Prepared bag or syringe contains JANX007 in NS. Administer IV through peripheral line via 0.2 micron inline filter. Infuse over 2 hours (+/- 15 min) for Cycle 1, then subsequent doses may be reduced by up to 30 minutes to minimum infusion time of 30 minutes. Prepared bag or syringe is stable 4 hours at room temp. 
For syringe, DO NOT FLUSH.
Caution: New Drug - Limited by federal (USA) Law to investigational use.  HAZARDOUS - handle with care.			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.
		  	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
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			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				OP Day 2	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	1. Pre-infusion vitals should be collected up to 30 minutes prior to infusion without pre-hydration requirements
2. Pre-infusion vitals should be obtained prior to starting pre-hydration and after completion of hydration and prior to infusion
3. Vital signs to be collected every 30 minutes (+/-10 minute window) during the infusion and all other timepoints. 
4. Take Vital Signs at End of Infusion (+10 min window)
5. Take Vital Signs 2-hr post end of infusion (+/- 20 min window)
6. Take Vital Signs 6-hr post end of infusion (+/- 1 hr window)
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	D-DIMER	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	FERRITIN LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	LACTIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	URINALYSIS SCREEN AND MICROSCOPY, WITH REFLEX TO CULTURE	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	AE/SAE Assessment
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Concomitant medications
				OP Day 8	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MISCELLANEOUS NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical examination
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	1. Pre-infusion vitals should be collected up to 30 minutes prior to infusion without pre-hydration requirements
2. Pre-infusion vitals should be obtained prior to starting pre-hydration and after completion of hydration and prior to infusion
3. Vital signs to be collected every 30 minutes (+/-10 minute window) during the infusion and all other timepoints. 
4. Take Vital Signs at End of Infusion (+10 min window)
5. Take Vital Signs 2-hr post end of infusion (+/- 20 min window)
6. Take Vital Signs 6-hr post end of infusion (+/- 1 hr window)
			Nursing Orders
  	INSERT PERIPHERAL IV	Interval: --	Occurrences: --	Comments:	Insert Peripheral IV x 2.
Research patient requires 1 peripheral IV on each arm, one for drug and one for blood draw. Ultra-sound guided for insertion assistance may be used.
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	FERRITIN LEVEL	Interval: --	Occurrences: --			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --			Labs
  	URINALYSIS SCREEN AND MICROSCOPY, WITH REFLEX TO CULTURE	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	AE/SAE Assessment
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Concomitant medications
			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.			Chemotherapy
  	INV-JANX007 in 0.9% NaCl Infusion (PSMA-007-001/Pro00038180/Efstathiou)	Dose: --	Route: intravenous	once for 1 dose	Start: S			Instructions:	Prepared bag or syringe contains JANX007 in NS. Administer IV through peripheral line via 0.2 micron inline filter. Infuse over 2 hours (+/- 15 min) for Cycle 1, then subsequent doses may be reduced by up to 30 minutes to minimum infusion time of 30 minutes. Prepared bag or syringe is stable 4 hours at room temp. 
For syringe, DO NOT FLUSH.
Caution: New Drug - Limited by federal (USA) Law to investigational use.  HAZARDOUS - handle with care.			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.
		  	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
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			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				OP Day 9	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	FERRITIN LEVEL	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	AE/SAE Assessment
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Concomitant medications
				OP Day 15	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MISCELLANEOUS NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical examination
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	1. Pre-infusion vitals should be collected up to 30 minutes prior to infusion without pre-hydration requirements
2. Pre-infusion vitals should be obtained prior to starting pre-hydration and after completion of hydration and prior to infusion
3. Vital signs to be collected every 30 minutes (+/-10 minute window) during the infusion and all other timepoints. 
4. Take Vital Signs at End of Infusion (+10 min window)
5. Take Vital Signs 2-hr post end of infusion (+/- 20 min window)
6. Take Vital Signs 6-hr post end of infusion (+/- 1 hr window)
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	D-DIMER	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	FERRITIN LEVEL	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --			Labs
  	LACTIC ACID LEVEL	Interval: --	Occurrences: --			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --			Labs
  	URINALYSIS SCREEN AND MICROSCOPY, WITH REFLEX TO CULTURE	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	AE/SAE Assessment
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Concomitant medications
			Nursing Orders
  	INSERT PERIPHERAL IV	Interval: --	Occurrences: --	Comments:	Insert Peripheral IV x 2.
Research patient requires 1 peripheral IV on each arm, one for drug and one for blood draw. Ultra-sound guided for insertion assistance may be used.
			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.			Chemotherapy
  	INV-JANX007 in 0.9% NaCl Infusion (PSMA-007-001/Pro00038180/Efstathiou)	Dose: --	Route: intravenous	once for 1 dose	Start: S			Instructions:	Prepared bag or syringe contains JANX007 in NS. Administer IV through peripheral line via 0.2 micron inline filter. Infuse over 2 hours (+/- 15 min) for Cycle 1, then subsequent doses may be reduced by up to 30 minutes to minimum infusion time of 30 minutes. Prepared bag or syringe is stable 4 hours at room temp. 
For syringe, DO NOT FLUSH.
Caution: New Drug - Limited by federal (USA) Law to investigational use.  HAZARDOUS - handle with care.			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.
		  	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
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			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				OP Day 16	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	D-DIMER	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	FERRITIN LEVEL	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	AE/SAE Assessment
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Concomitant medications
				OP Day 18	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --			Labs
  	FERRITIN LEVEL	Interval: --	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	AE/SAE Assessment
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Concomitant medications
			Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --					
OP Cycle 3 and beyond	Repeat 1 time	Cycle length: 21 days	OP Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MISCELLANEOUS NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical examination
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Pre-Infusion ECG 12 Lead

Clinical Indications: Rate/Rhythm
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	FERRITIN LEVEL	Interval: --	Occurrences: --			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --			Labs
  	URINALYSIS SCREEN AND MICROSCOPY, WITH REFLEX TO CULTURE	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	AE/SAE Assessment
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Concomitant medications
			Nursing Orders
  	INSERT PERIPHERAL IV	Interval: --	Occurrences: --	Comments:	Insert Peripheral IV x 2.
Research patient requires 1 peripheral IV on each arm, one for drug and one for blood draw. Ultra-sound guided for insertion assistance may be used.
			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.			Chemotherapy
  	INV-JANX007 in 0.9% NaCl Infusion (PSMA-007-001/Pro00038180/Efstathiou)	Dose: --	Route: intravenous	once for 1 dose	Start: S			Instructions:	Prepared bag or syringe contains JANX007 in NS. Administer IV through peripheral line via 0.2 micron inline filter. Infuse over 2 hours (+/- 15 min) for Cycle 1, then subsequent doses may be reduced by up to 30 minutes to minimum infusion time of 30 minutes. Prepared bag or syringe is stable 4 hours at room temp. 
For syringe, DO NOT FLUSH.
Caution: New Drug - Limited by federal (USA) Law to investigational use.  HAZARDOUS - handle with care.			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Post-Infusion ECG 12 Lead

Clinical Indications: Rate/Rhythm
			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.
		  	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
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			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				OP Day 15	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	AE/SAE Assessment
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Concomitant medications
			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.			Chemotherapy
  	INV-JANX007 in 0.9% NaCl Infusion (PSMA-007-001/Pro00038180/Efstathiou)	Dose: --	Route: intravenous	once for 1 dose	Start: S			Instructions:	Prepared bag or syringe contains JANX007 in NS. Administer IV through peripheral line via 0.2 micron inline filter. Infuse over 2 hours (+/- 15 min) for Cycle 1, then subsequent doses may be reduced by up to 30 minutes to minimum infusion time of 30 minutes. Prepared bag or syringe is stable 4 hours at room temp. 
For syringe, DO NOT FLUSH.
Caution: New Drug - Limited by federal (USA) Law to investigational use.  HAZARDOUS - handle with care.			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.
		  	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
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			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					
EOT	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MISCELLANEOUS NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Physical examination
			Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --			Labs
  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	FERRITIN LEVEL	Interval: --	Occurrences: --			Labs
  	PROSTATE SPECIFIC ANTIGEN	Interval: --	Occurrences: --			Labs
  	URINALYSIS SCREEN AND MICROSCOPY, WITH REFLEX TO CULTURE	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	AE/SAE Assessment
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Concomitant medications
			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Tumor Assessment