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RESEARCH PRO00021342 NIRAVATH DS8201-A-U303	

Types:      Research Oncology Treatment
Synonyms:  METASTATIC, BREAST, HER2 LOW, HER2LOW, 21342, PRO21342

Pre Study Screening	Repeat 1 time	Cycle length: 28 days	-28 to -1 days prior to randomization	Perform every 1 day x1		Pharmacodynamic Assessments
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	Main informed consent
			Labs
  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS C ANTIBODY	Interval: --	Occurrences: --			Provider Communication
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Declaration of Investigator's choice paradigm
			Miscellaneous
  	VISUAL ACUITY SCREENING	Interval: --	Occurrences: --		  	SLIT LAMP PHOTOGRAPHY - OU - BOTH EYES	Interval: --	Occurrences: --		  	FUNDUS PHOTOS - OU - BOTH EYES	Interval: --	Occurrences: --	Comments:	Fundoscopy
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	Or MUGA as appropriate
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	Or Echo 3D with Contrast as appropriate
			Imaging
☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI as appropriate
		☑	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI as appropriate
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate
				-14 to -1 days prior to randomization	Perform every 1 day x1		Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Complete questionnaires (HEOR, EORTC C30 & BR45, and 5L)
			Nursing Orders
  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	History and Physical
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	URINALYSIS SCREEN AND MICROSCOPY, WITH REFLEX TO CULTURE	Interval: --	Occurrences: --		  	TROPONIN	Interval: --	Occurrences: --		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
			Provider Communication
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Physician's selection of Physician's Choice Paradigm (1 of the following drugs) 
o Capecitabine 
o Eribulin 
o Paclitaxel 
o Nab-paclitaxel 
o Gemcitabine
					
Randomization (2:1 randomization to either DS-8201A or Investigator’s choice)	Repeat 1 time	Cycle length: 1 day	Day 1	Perform every 1 day x1		Provider Communication
  	TREATMENT CONDITIONS	Interval: --	Occurrences: --	Comments:	o Absolute neutrophil count (ANC) GREATER than or EQUAL to 1,500/mm3 
o Platelets GREATER than or EQUAL to 100,000/mm3, Hemoglobin GREATER than or EQUAL to 8 g/dL
		  	TREATMENT CONDITIONS 3	Interval: --	Occurrences: --	Comments:	o Serum creatinine LESS than or EQUAL to 1.5 X upper limit of normal (ULN) OR Measured or calculated (CrCl should be calculated per institutional standard) 
o Creatinine clearance (CrCl) (glomerular filtration rate can be used in place of creatinine or CrCl) GREATER than or EQUAL to 60 mL/min for subject with creatinine levels GREATER than  1.5 X institutional ULN 
o Glomerular filtration rate (GFR) GREATER than or EQUAL to  30 mL/min/1.73 m2
		  	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	o Serum total bilirubin LESS than or EQUAL to  1.5 X ULN. Known Gilbert syndrome is allowed if total bilirubin is LESS than or EQUAL to 3 X ULN 
o ALT and AST and ALP LESS than or EQUAL to  2.5 X ULN OR LESS than or EQUAL to  5 X ULN for subjects with liver metastases, Lipase LESS than 2 X ULN 
o International normalized ratio (INR) and partial thromboplastin time (PTT) or activated PTT (aPTT) LESS than or EQUAL to 1.5 X ULN unless subject is receiving anticoagulant therapy
		  	TREATMENT CONDITIONS 11	Interval: --	Occurrences: --	Comments:	Serum Pregnancy test must be negative prior to study drug administration
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Take-Home Medications Prior to Treatment
☐	capecitabine (XELODA) 500 mg chemo tablet	Dose: --	Route: oral	2 times daily	Dispense: --	Refills: 0	Start: S				☐	ondansetron (ZOFRAN) 8 MG tablet	Dose: 8 mg	Route: oral	PRN	Dispense: --	Refills: 0	Start: S				☐	loperamide (IMODIUM) 2 mg capsule	Dose: 2 mg	Route: oral	PRN	Dispense: --	Refills: 0	Start: S							
Cycle 1	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Line Flush
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201a Study Drug.		☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with DS8201a Study Drug.			Nursing Orders
☑	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for DS8201a Study Drug		☐	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.  Do NOT administer with DS8201a Study Drug.			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Perform all labs and procedures prior to study med administration unless stated otherwise
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Pre-Medications
◉	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S					Pre-Medications
☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow IV push 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) 50 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 50 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S	End: S 11:45 AM		Instructions:	Administer 30 minutes prior to chemotherapy.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DIPHENHYDRAMINE 50 MG/ML INJECTION SOLUTION	Medications	50 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.			Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Prohibited Medication and Treatments:
o Other anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid, or anticancer hormonal treatment; 
o Other investigational therapeutic agents; 
o Radiotherapy (except for palliative radiation to known metastatic sites as long as it does not affect assessment of response or interrupt treatment for more than the maximum time specified in dose modification section); 
o Radiotherapy to the thorax; 
o Concomitant use of chronic systemic (IV or oral) corticosteroids or other immunosuppressive medications except for managing AEs (inhaled steroids or intraarticular steroid injections are permitted in this study); 
o Subjects with bronchopulmonary disorders who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
			Chemotherapy
◯	INV-DS8201a (DS8201a-U303 study/Niravath/Pro00021342) in dextrose 5% 250 mL IVPB	Dose: --	Route: intravenous	once over 90 Minutes for 1 dose			Offset: 30 Minutes	Instructions:	Infuse via inline filter tubing (use of PAClitaxel tubing is optional). Infuse first dose over 90 minutes. Subsequent doses infused over 30 minutes if no infusion reaction with previous dose. Post infusion, flush line with D5W volume equal to tubing volume. DO NOT use NS. Protect from light.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DS8201A 100 MG SOLUTION FOR INJECTION  (DS8201A-U303 STUDY/NIRAVATH/PRO00021342)	Medications	 	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Nursing Orders
☐	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Verify that the patient has taken oral Xeloda
			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o ALT/AST GREATER than 2.5 times upper normal limit.
			Chemotherapy
☐	INV-Eribulin intravenous push (DS8201a-U303 study/Niravath/pro00021342) injection	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Prepared on/at: _____ expires on/at:____ (4 hours room temperature). Administer as slow inravenous push over 2 to 5 minutes.			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	ondansetron (ZOFRAN) 8 mg, dexamethasone (DECADRON) 20 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 8 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	8 mg	Main Ingredient	Yes	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	20 mg	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	INV-PACLItaxel (DS8201a-U303 study/Niravath/Pro00021342) in sodium chloride (NON-PVC) 0.9 % 500 mL chemo IVPB	Dose: --	Route: intravenous	once over 3 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Prepared on/at:_______ expires on/at:______ (24 hours at room temp). Infuse via 0.22 micro in-line filter over 30 minutes.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PACLITAXEL 6 MG/ML CONCENTRATE,INTRAVENOUS (DS8201A-U303 STUDY/NIRAVATH/PRO00021342)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % IV SOLP (EXCEL;NON-PVC)	QS Base	500 mL	Yes	Yes				Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	NAB-PACLItaxel (ABRAXANE) chemo infusion	Dose: --	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	gemcitabine (GEMZAR) in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	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.
		  	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					Nursing Orders
☑	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
		☑	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
			Labs
☑	TROPONIN	Interval: --	Occurrences: --	Comments:	To be done at 2-3 hours post EOI; may need to repeat in intervals as listed in the protocol if indication of myocardial infarction
			Nursing Orders
☑	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o To be done at end of infusion ONLY if troponin levels indicate myocardial infarction 
o Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Imaging
☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI as appropriate. To be done EVERY 6 weeks during study.
		☐	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or MRI as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated)
o To be done EVERY 6 weeks during study
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or CT as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated) 
o To be done EVERY 6 weeks during study
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201a Study Drug.		☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.				Day 8	Perform every 1 day x1		Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --				Day 15	Perform every 1 day x1		Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --					
Cycle 2	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Line Flush
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201a Study Drug.		☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with DS8201a Study Drug.			Nursing Orders
☑	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for DS8201a Study Drug		☐	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.  Do NOT administer with DS8201a Study Drug.			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Perform all labs and procedures prior to study med administration unless stated otherwise
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Pre-Medications
◉	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S					Pre-Medications
☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow IV push 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) 50 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 50 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S	End: S 11:45 AM		Instructions:	Administer 30 minutes prior to chemotherapy.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DIPHENHYDRAMINE 50 MG/ML INJECTION SOLUTION	Medications	50 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.			Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Prohibited Medication and Treatments:
o Other anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid, or anticancer hormonal treatment; 
o Other investigational therapeutic agents; 
o Radiotherapy (except for palliative radiation to known metastatic sites as long as it does not affect assessment of response or interrupt treatment for more than the maximum time specified in dose modification section); 
o Radiotherapy to the thorax; 
o Concomitant use of chronic systemic (IV or oral) corticosteroids or other immunosuppressive medications except for managing AEs (inhaled steroids or intraarticular steroid injections are permitted in this study); 
o Subjects with bronchopulmonary disorders who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
			Chemotherapy
◯	INV-DS8201a (DS8201a-U303 study/Niravath/Pro00021342) in dextrose 5% 250 mL IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Infuse via inline filter tubing (use of PAClitaxel tubing is optional). Infuse first dose over 90 minutes. Subsequent doses infused over 30 minutes if no infusion reaction with previous dose. Post infusion, flush line with D5W volume equal to tubing volume. DO NOT use NS. Protect from light.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DS8201A 100 MG SOLUTION FOR INJECTION  (DS8201A-U303 STUDY/NIRAVATH/PRO00021342)	Medications	 	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Nursing Orders
☐	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Verify that the patient has taken oral Xeloda
			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o ALT/AST GREATER than 2.5 times upper normal limit.
			Chemotherapy
☐	INV-Eribulin intravenous push (DS8201a-U303 study/Niravath/pro00021342) injection	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Prepared on/at: _____ expires on/at:____ (4 hours room temperature). Administer as slow inravenous push over 2 to 5 minutes.			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	ondansetron (ZOFRAN) 8 mg, dexamethasone (DECADRON) 20 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 8 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	8 mg	Main Ingredient	Yes	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	20 mg	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	INV-PACLItaxel (DS8201a-U303 study/Niravath/Pro00021342) in sodium chloride (NON-PVC) 0.9 % 500 mL chemo IVPB	Dose: --	Route: intravenous	once over 3 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Prepared on/at:_______ expires on/at:______ (24 hours at room temp). Infuse via 0.22 micro in-line filter over 30 minutes.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PACLITAXEL 6 MG/ML CONCENTRATE,INTRAVENOUS (DS8201A-U303 STUDY/NIRAVATH/PRO00021342)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % IV SOLP (EXCEL;NON-PVC)	QS Base	500 mL	Yes	Yes				Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	NAB-PACLItaxel (ABRAXANE) chemo infusion	Dose: --	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	gemcitabine (GEMZAR) in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	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.
		  	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					Nursing Orders
☑	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
		☑	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
			Labs
☑	TROPONIN	Interval: --	Occurrences: --	Comments:	To be done at 2-3 hours post EOI; may need to repeat in intervals as listed in the protocol if indication of myocardial infarction
			Nursing Orders
☑	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o To be done at end of infusion ONLY if troponin levels indicate myocardial infarction 
o Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201a Study Drug.		☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 3	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Line Flush
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201a Study Drug.		☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with DS8201a Study Drug.			Nursing Orders
☑	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for DS8201a Study Drug		☐	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.  Do NOT administer with DS8201a Study Drug.			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Perform all labs and procedures prior to study med administration unless stated otherwise
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Complete questionnaires (HEOR, EORTC C30 & BR45, and 5L)
			Pre-Medications
◉	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S					Pre-Medications
☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow IV push 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) 50 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 50 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S	End: S 11:45 AM		Instructions:	Administer 30 minutes prior to chemotherapy.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DIPHENHYDRAMINE 50 MG/ML INJECTION SOLUTION	Medications	50 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.			Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Prohibited Medication and Treatments:
o Other anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid, or anticancer hormonal treatment; 
o Other investigational therapeutic agents; 
o Radiotherapy (except for palliative radiation to known metastatic sites as long as it does not affect assessment of response or interrupt treatment for more than the maximum time specified in dose modification section); 
o Radiotherapy to the thorax; 
o Concomitant use of chronic systemic (IV or oral) corticosteroids or other immunosuppressive medications except for managing AEs (inhaled steroids or intraarticular steroid injections are permitted in this study); 
o Subjects with bronchopulmonary disorders who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
			Chemotherapy
◯	INV-DS8201a (DS8201a-U303 study/Niravath/Pro00021342) in dextrose 5% 250 mL IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Infuse via inline filter tubing (use of PAClitaxel tubing is optional). Infuse first dose over 90 minutes. Subsequent doses infused over 30 minutes if no infusion reaction with previous dose. Post infusion, flush line with D5W volume equal to tubing volume. DO NOT use NS. Protect from light.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DS8201A 100 MG SOLUTION FOR INJECTION  (DS8201A-U303 STUDY/NIRAVATH/PRO00021342)	Medications	 	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Nursing Orders
☐	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Verify that the patient has taken oral Xeloda
			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o ALT/AST GREATER than 2.5 times upper normal limit.
			Chemotherapy
☐	INV-Eribulin intravenous push (DS8201a-U303 study/Niravath/pro00021342) injection	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Prepared on/at: _____ expires on/at:____ (4 hours room temperature). Administer as slow inravenous push over 2 to 5 minutes.			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	ondansetron (ZOFRAN) 8 mg, dexamethasone (DECADRON) 20 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 8 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	8 mg	Main Ingredient	Yes	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	20 mg	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	INV-PACLItaxel (DS8201a-U303 study/Niravath/Pro00021342) in sodium chloride (NON-PVC) 0.9 % 500 mL chemo IVPB	Dose: --	Route: intravenous	once over 3 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Prepared on/at:_______ expires on/at:______ (24 hours at room temp). Infuse via 0.22 micro in-line filter over 30 minutes.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PACLITAXEL 6 MG/ML CONCENTRATE,INTRAVENOUS (DS8201A-U303 STUDY/NIRAVATH/PRO00021342)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % IV SOLP (EXCEL;NON-PVC)	QS Base	500 mL	Yes	Yes				Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	NAB-PACLItaxel (ABRAXANE) chemo infusion	Dose: --	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	gemcitabine (GEMZAR) in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	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.
		  	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					Nursing Orders
☑	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
		☑	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
			Labs
☑	TROPONIN	Interval: --	Occurrences: --	Comments:	To be done at 2-3 hours post EOI; may need to repeat in intervals as listed in the protocol if indication of myocardial infarction
			Nursing Orders
☑	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o To be done at end of infusion ONLY if troponin levels indicate myocardial infarction 
o Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Imaging
☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI as appropriate. To be done EVERY 6 weeks during study.
		☐	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or MRI as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated)
o To be done EVERY 6 weeks during study
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or CT as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated) 
o To be done EVERY 6 weeks during study
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201a Study Drug.		☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 4	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Line Flush
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201a Study Drug.		☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with DS8201a Study Drug.			Nursing Orders
☑	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for DS8201a Study Drug		☐	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.  Do NOT administer with DS8201a Study Drug.			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Perform all labs and procedures prior to study med administration unless stated otherwise
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	Or MUGA as appropriate
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	Or Echo as appropriate
			Pre-Medications
◉	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S					Pre-Medications
☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow IV push 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) 50 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 50 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S	End: S 11:45 AM		Instructions:	Administer 30 minutes prior to chemotherapy.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DIPHENHYDRAMINE 50 MG/ML INJECTION SOLUTION	Medications	50 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.			Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Prohibited Medication and Treatments:
o Other anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid, or anticancer hormonal treatment; 
o Other investigational therapeutic agents; 
o Radiotherapy (except for palliative radiation to known metastatic sites as long as it does not affect assessment of response or interrupt treatment for more than the maximum time specified in dose modification section); 
o Radiotherapy to the thorax; 
o Concomitant use of chronic systemic (IV or oral) corticosteroids or other immunosuppressive medications except for managing AEs (inhaled steroids or intraarticular steroid injections are permitted in this study); 
o Subjects with bronchopulmonary disorders who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
			Chemotherapy
◯	INV-DS8201a (DS8201a-U303 study/Niravath/Pro00021342) in dextrose 5% 250 mL IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Infuse via inline filter tubing (use of PAClitaxel tubing is optional). Infuse first dose over 90 minutes. Subsequent doses infused over 30 minutes if no infusion reaction with previous dose. Post infusion, flush line with D5W volume equal to tubing volume. DO NOT use NS. Protect from light.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DS8201A 100 MG SOLUTION FOR INJECTION  (DS8201A-U303 STUDY/NIRAVATH/PRO00021342)	Medications	 	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Nursing Orders
☐	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Verify that the patient has taken oral Xeloda
			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o ALT/AST GREATER than 2.5 times upper normal limit.
			Chemotherapy
☐	INV-Eribulin intravenous push (DS8201a-U303 study/Niravath/pro00021342) injection	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Prepared on/at: _____ expires on/at:____ (4 hours room temperature). Administer as slow inravenous push over 2 to 5 minutes.			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	ondansetron (ZOFRAN) 8 mg, dexamethasone (DECADRON) 20 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 8 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	8 mg	Main Ingredient	Yes	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	20 mg	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	INV-PACLItaxel (DS8201a-U303 study/Niravath/Pro00021342) in sodium chloride (NON-PVC) 0.9 % 500 mL chemo IVPB	Dose: --	Route: intravenous	once over 3 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Prepared on/at:_______ expires on/at:______ (24 hours at room temp). Infuse via 0.22 micro in-line filter over 30 minutes.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PACLITAXEL 6 MG/ML CONCENTRATE,INTRAVENOUS (DS8201A-U303 STUDY/NIRAVATH/PRO00021342)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % IV SOLP (EXCEL;NON-PVC)	QS Base	500 mL	Yes	Yes				Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	NAB-PACLItaxel (ABRAXANE) chemo infusion	Dose: --	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	gemcitabine (GEMZAR) in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	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.
		  	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					Nursing Orders
☑	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
		☑	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
			Labs
☑	TROPONIN	Interval: --	Occurrences: --	Comments:	To be done at 2-3 hours post EOI; may need to repeat in intervals as listed in the protocol if indication of myocardial infarction
			Nursing Orders
☑	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o To be done at end of infusion ONLY if troponin levels indicate myocardial infarction 
o Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201a Study Drug.		☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 5	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Line Flush
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201a Study Drug.		☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with DS8201a Study Drug.			Nursing Orders
☑	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for DS8201a Study Drug		☐	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.  Do NOT administer with DS8201a Study Drug.			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Perform all labs and procedures prior to study med administration unless stated otherwise
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Complete questionnaires (HEOR, EORTC C30 & BR45, and 5L)
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	Or MUGA as appropriate
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	Or Echo as appropriate
			Pre-Medications
◉	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S					Pre-Medications
☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow IV push 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) 50 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 50 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S	End: S 11:45 AM		Instructions:	Administer 30 minutes prior to chemotherapy.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DIPHENHYDRAMINE 50 MG/ML INJECTION SOLUTION	Medications	50 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.			Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Prohibited Medication and Treatments:
o Other anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid, or anticancer hormonal treatment; 
o Other investigational therapeutic agents; 
o Radiotherapy (except for palliative radiation to known metastatic sites as long as it does not affect assessment of response or interrupt treatment for more than the maximum time specified in dose modification section); 
o Radiotherapy to the thorax; 
o Concomitant use of chronic systemic (IV or oral) corticosteroids or other immunosuppressive medications except for managing AEs (inhaled steroids or intraarticular steroid injections are permitted in this study); 
o Subjects with bronchopulmonary disorders who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
			Chemotherapy
◯	INV-DS8201a (DS8201a-U303 study/Niravath/Pro00021342) in dextrose 5% 250 mL IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Infuse via inline filter tubing (use of PAClitaxel tubing is optional). Infuse first dose over 90 minutes. Subsequent doses infused over 30 minutes if no infusion reaction with previous dose. Post infusion, flush line with D5W volume equal to tubing volume. DO NOT use NS. Protect from light.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DS8201A 100 MG SOLUTION FOR INJECTION  (DS8201A-U303 STUDY/NIRAVATH/PRO00021342)	Medications	 	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Nursing Orders
☐	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Verify that the patient has taken oral Xeloda
			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o ALT/AST GREATER than 2.5 times upper normal limit.
			Chemotherapy
☐	INV-Eribulin intravenous push (DS8201a-U303 study/Niravath/pro00021342) injection	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Prepared on/at: _____ expires on/at:____ (4 hours room temperature). Administer as slow inravenous push over 2 to 5 minutes.			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	ondansetron (ZOFRAN) 8 mg, dexamethasone (DECADRON) 20 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 8 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	8 mg	Main Ingredient	Yes	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	20 mg	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	INV-PACLItaxel (DS8201a-U303 study/Niravath/Pro00021342) in sodium chloride (NON-PVC) 0.9 % 500 mL chemo IVPB	Dose: --	Route: intravenous	once over 3 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Prepared on/at:_______ expires on/at:______ (24 hours at room temp). Infuse via 0.22 micro in-line filter over 30 minutes.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PACLITAXEL 6 MG/ML CONCENTRATE,INTRAVENOUS (DS8201A-U303 STUDY/NIRAVATH/PRO00021342)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % IV SOLP (EXCEL;NON-PVC)	QS Base	500 mL	Yes	Yes				Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	NAB-PACLItaxel (ABRAXANE) chemo infusion	Dose: --	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	gemcitabine (GEMZAR) in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	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.
		  	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					Nursing Orders
☑	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
		☑	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
			Labs
☑	TROPONIN	Interval: --	Occurrences: --	Comments:	To be done at 2-3 hours post EOI; may need to repeat in intervals as listed in the protocol if indication of myocardial infarction
			Nursing Orders
☑	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o To be done at end of infusion ONLY if troponin levels indicate myocardial infarction 
o Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Imaging
☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI as appropriate. To be done EVERY 6 weeks during study.
		☐	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or MRI as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated)
o To be done EVERY 6 weeks during study
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or CT as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated) 
o To be done EVERY 6 weeks during study
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201a Study Drug.		☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 6	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Line Flush
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201a Study Drug.		☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with DS8201a Study Drug.			Nursing Orders
☑	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for DS8201a Study Drug		☐	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.  Do NOT administer with DS8201a Study Drug.			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Perform all labs and procedures prior to study med administration unless stated otherwise
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Pre-Medications
◉	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S					Pre-Medications
☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow IV push 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) 50 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 50 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S	End: S 11:45 AM		Instructions:	Administer 30 minutes prior to chemotherapy.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DIPHENHYDRAMINE 50 MG/ML INJECTION SOLUTION	Medications	50 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.			Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Prohibited Medication and Treatments:
o Other anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid, or anticancer hormonal treatment; 
o Other investigational therapeutic agents; 
o Radiotherapy (except for palliative radiation to known metastatic sites as long as it does not affect assessment of response or interrupt treatment for more than the maximum time specified in dose modification section); 
o Radiotherapy to the thorax; 
o Concomitant use of chronic systemic (IV or oral) corticosteroids or other immunosuppressive medications except for managing AEs (inhaled steroids or intraarticular steroid injections are permitted in this study); 
o Subjects with bronchopulmonary disorders who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
			Chemotherapy
◯	INV-DS8201a (DS8201a-U303 study/Niravath/Pro00021342) in dextrose 5% 250 mL IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Infuse via inline filter tubing (use of PAClitaxel tubing is optional). Infuse first dose over 90 minutes. Subsequent doses infused over 30 minutes if no infusion reaction with previous dose. Post infusion, flush line with D5W volume equal to tubing volume. DO NOT use NS. Protect from light.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DS8201A 100 MG SOLUTION FOR INJECTION  (DS8201A-U303 STUDY/NIRAVATH/PRO00021342)	Medications	 	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Nursing Orders
☐	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Verify that the patient has taken oral Xeloda
			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o ALT/AST GREATER than 2.5 times upper normal limit.
			Chemotherapy
☐	INV-Eribulin intravenous push (DS8201a-U303 study/Niravath/pro00021342) injection	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Prepared on/at: _____ expires on/at:____ (4 hours room temperature). Administer as slow inravenous push over 2 to 5 minutes.			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	ondansetron (ZOFRAN) 8 mg, dexamethasone (DECADRON) 20 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 8 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	8 mg	Main Ingredient	Yes	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	20 mg	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	INV-PACLItaxel (DS8201a-U303 study/Niravath/Pro00021342) in sodium chloride (NON-PVC) 0.9 % 500 mL chemo IVPB	Dose: --	Route: intravenous	once over 3 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Prepared on/at:_______ expires on/at:______ (24 hours at room temp). Infuse via 0.22 micro in-line filter over 30 minutes.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PACLITAXEL 6 MG/ML CONCENTRATE,INTRAVENOUS (DS8201A-U303 STUDY/NIRAVATH/PRO00021342)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % IV SOLP (EXCEL;NON-PVC)	QS Base	500 mL	Yes	Yes				Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	NAB-PACLItaxel (ABRAXANE) chemo infusion	Dose: --	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	gemcitabine (GEMZAR) in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	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.
		  	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					Nursing Orders
☑	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
		☑	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
			Labs
☑	TROPONIN	Interval: --	Occurrences: --	Comments:	To be done at 2-3 hours post EOI; may need to repeat in intervals as listed in the protocol if indication of myocardial infarction
			Nursing Orders
☑	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o To be done at end of infusion ONLY if troponin levels indicate myocardial infarction 
o Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201a Study Drug.		☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 7	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Line Flush
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201a Study Drug.		☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with DS8201a Study Drug.			Nursing Orders
☑	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for DS8201a Study Drug		☐	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.  Do NOT administer with DS8201a Study Drug.			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Perform all labs and procedures prior to study med administration unless stated otherwise
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Complete questionnaires (HEOR, EORTC C30 & BR45, and 5L)
			Pre-Medications
◉	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S					Pre-Medications
☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow IV push 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) 50 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 50 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S	End: S 11:45 AM		Instructions:	Administer 30 minutes prior to chemotherapy.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DIPHENHYDRAMINE 50 MG/ML INJECTION SOLUTION	Medications	50 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.			Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Prohibited Medication and Treatments:
o Other anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid, or anticancer hormonal treatment; 
o Other investigational therapeutic agents; 
o Radiotherapy (except for palliative radiation to known metastatic sites as long as it does not affect assessment of response or interrupt treatment for more than the maximum time specified in dose modification section); 
o Radiotherapy to the thorax; 
o Concomitant use of chronic systemic (IV or oral) corticosteroids or other immunosuppressive medications except for managing AEs (inhaled steroids or intraarticular steroid injections are permitted in this study); 
o Subjects with bronchopulmonary disorders who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
			Chemotherapy
◯	INV-DS8201a (DS8201a-U303 study/Niravath/Pro00021342) in dextrose 5% 250 mL IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Infuse via inline filter tubing (use of PAClitaxel tubing is optional). Infuse first dose over 90 minutes. Subsequent doses infused over 30 minutes if no infusion reaction with previous dose. Post infusion, flush line with D5W volume equal to tubing volume. DO NOT use NS. Protect from light.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DS8201A 100 MG SOLUTION FOR INJECTION  (DS8201A-U303 STUDY/NIRAVATH/PRO00021342)	Medications	 	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Nursing Orders
☐	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Verify that the patient has taken oral Xeloda
			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o ALT/AST GREATER than 2.5 times upper normal limit.
			Chemotherapy
☐	INV-Eribulin intravenous push (DS8201a-U303 study/Niravath/pro00021342) injection	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Prepared on/at: _____ expires on/at:____ (4 hours room temperature). Administer as slow inravenous push over 2 to 5 minutes.			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	ondansetron (ZOFRAN) 8 mg, dexamethasone (DECADRON) 20 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 8 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	8 mg	Main Ingredient	Yes	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	20 mg	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	INV-PACLItaxel (DS8201a-U303 study/Niravath/Pro00021342) in sodium chloride (NON-PVC) 0.9 % 500 mL chemo IVPB	Dose: --	Route: intravenous	once over 3 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Prepared on/at:_______ expires on/at:______ (24 hours at room temp). Infuse via 0.22 micro in-line filter over 30 minutes.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PACLITAXEL 6 MG/ML CONCENTRATE,INTRAVENOUS (DS8201A-U303 STUDY/NIRAVATH/PRO00021342)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % IV SOLP (EXCEL;NON-PVC)	QS Base	500 mL	Yes	Yes				Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	NAB-PACLItaxel (ABRAXANE) chemo infusion	Dose: --	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	gemcitabine (GEMZAR) in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	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.
		  	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					Nursing Orders
☑	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
		☑	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
			Labs
☑	TROPONIN	Interval: --	Occurrences: --	Comments:	To be done at 2-3 hours post EOI; may need to repeat in intervals as listed in the protocol if indication of myocardial infarction
			Nursing Orders
☑	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o To be done at end of infusion ONLY if troponin levels indicate myocardial infarction 
o Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Imaging
☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI as appropriate. To be done EVERY 6 weeks during study.
		☐	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or MRI as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated)
o To be done EVERY 6 weeks during study
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or CT as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated) 
o To be done EVERY 6 weeks during study
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201a Study Drug.		☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 8	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Line Flush
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201a Study Drug.		☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with DS8201a Study Drug.			Nursing Orders
☑	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for DS8201a Study Drug		☐	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.  Do NOT administer with DS8201a Study Drug.			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Perform all labs and procedures prior to study med administration unless stated otherwise
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Pre-Medications
◉	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S					Pre-Medications
☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow IV push 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) 50 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 50 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S	End: S 11:45 AM		Instructions:	Administer 30 minutes prior to chemotherapy.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DIPHENHYDRAMINE 50 MG/ML INJECTION SOLUTION	Medications	50 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.			Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Prohibited Medication and Treatments:
o Other anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid, or anticancer hormonal treatment; 
o Other investigational therapeutic agents; 
o Radiotherapy (except for palliative radiation to known metastatic sites as long as it does not affect assessment of response or interrupt treatment for more than the maximum time specified in dose modification section); 
o Radiotherapy to the thorax; 
o Concomitant use of chronic systemic (IV or oral) corticosteroids or other immunosuppressive medications except for managing AEs (inhaled steroids or intraarticular steroid injections are permitted in this study); 
o Subjects with bronchopulmonary disorders who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
			Chemotherapy
◯	INV-DS8201a (DS8201a-U303 study/Niravath/Pro00021342) in dextrose 5% 250 mL IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Infuse via inline filter tubing (use of PAClitaxel tubing is optional). Infuse first dose over 90 minutes. Subsequent doses infused over 30 minutes if no infusion reaction with previous dose. Post infusion, flush line with D5W volume equal to tubing volume. DO NOT use NS. Protect from light.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DS8201A 100 MG SOLUTION FOR INJECTION  (DS8201A-U303 STUDY/NIRAVATH/PRO00021342)	Medications	 	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Nursing Orders
☐	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Verify that the patient has taken oral Xeloda
			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o ALT/AST GREATER than 2.5 times upper normal limit.
			Chemotherapy
☐	INV-Eribulin intravenous push (DS8201a-U303 study/Niravath/pro00021342) injection	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Prepared on/at: _____ expires on/at:____ (4 hours room temperature). Administer as slow inravenous push over 2 to 5 minutes.			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	ondansetron (ZOFRAN) 8 mg, dexamethasone (DECADRON) 20 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 8 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	8 mg	Main Ingredient	Yes	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	20 mg	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	INV-PACLItaxel (DS8201a-U303 study/Niravath/Pro00021342) in sodium chloride (NON-PVC) 0.9 % 500 mL chemo IVPB	Dose: --	Route: intravenous	once over 3 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Prepared on/at:_______ expires on/at:______ (24 hours at room temp). Infuse via 0.22 micro in-line filter over 30 minutes.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PACLITAXEL 6 MG/ML CONCENTRATE,INTRAVENOUS (DS8201A-U303 STUDY/NIRAVATH/PRO00021342)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % IV SOLP (EXCEL;NON-PVC)	QS Base	500 mL	Yes	Yes				Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	NAB-PACLItaxel (ABRAXANE) chemo infusion	Dose: --	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	gemcitabine (GEMZAR) in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	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.
		  	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					Nursing Orders
☑	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
		☑	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
			Labs
☑	TROPONIN	Interval: --	Occurrences: --	Comments:	To be done at 2-3 hours post EOI; may need to repeat in intervals as listed in the protocol if indication of myocardial infarction
			Nursing Orders
☑	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o To be done at end of infusion ONLY if troponin levels indicate myocardial infarction 
o Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201a Study Drug.		☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 9	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Line Flush
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201a Study Drug.		☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with DS8201a Study Drug.			Nursing Orders
☑	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for DS8201a Study Drug		☐	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.  Do NOT administer with DS8201a Study Drug.			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Perform all labs and procedures prior to study med administration unless stated otherwise
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Complete questionnaires (HEOR, EORTC C30 & BR45, and 5L)
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	Or MUGA as appropriate
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	Or Echo as appropriate
			Pre-Medications
◉	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S					Pre-Medications
☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow IV push 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) 50 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 50 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S	End: S 11:45 AM		Instructions:	Administer 30 minutes prior to chemotherapy.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DIPHENHYDRAMINE 50 MG/ML INJECTION SOLUTION	Medications	50 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.			Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Prohibited Medication and Treatments:
o Other anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid, or anticancer hormonal treatment; 
o Other investigational therapeutic agents; 
o Radiotherapy (except for palliative radiation to known metastatic sites as long as it does not affect assessment of response or interrupt treatment for more than the maximum time specified in dose modification section); 
o Radiotherapy to the thorax; 
o Concomitant use of chronic systemic (IV or oral) corticosteroids or other immunosuppressive medications except for managing AEs (inhaled steroids or intraarticular steroid injections are permitted in this study); 
o Subjects with bronchopulmonary disorders who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
			Chemotherapy
◯	INV-DS8201a (DS8201a-U303 study/Niravath/Pro00021342) in dextrose 5% 250 mL IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Infuse via inline filter tubing (use of PAClitaxel tubing is optional). Infuse first dose over 90 minutes. Subsequent doses infused over 30 minutes if no infusion reaction with previous dose. Post infusion, flush line with D5W volume equal to tubing volume. DO NOT use NS. Protect from light.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DS8201A 100 MG SOLUTION FOR INJECTION  (DS8201A-U303 STUDY/NIRAVATH/PRO00021342)	Medications	 	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Nursing Orders
☐	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Verify that the patient has taken oral Xeloda
			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o ALT/AST GREATER than 2.5 times upper normal limit.
			Chemotherapy
☐	INV-Eribulin intravenous push (DS8201a-U303 study/Niravath/pro00021342) injection	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Prepared on/at: _____ expires on/at:____ (4 hours room temperature). Administer as slow inravenous push over 2 to 5 minutes.			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	ondansetron (ZOFRAN) 8 mg, dexamethasone (DECADRON) 20 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 8 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	8 mg	Main Ingredient	Yes	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	20 mg	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	INV-PACLItaxel (DS8201a-U303 study/Niravath/Pro00021342) in sodium chloride (NON-PVC) 0.9 % 500 mL chemo IVPB	Dose: --	Route: intravenous	once over 3 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Prepared on/at:_______ expires on/at:______ (24 hours at room temp). Infuse via 0.22 micro in-line filter over 30 minutes.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PACLITAXEL 6 MG/ML CONCENTRATE,INTRAVENOUS (DS8201A-U303 STUDY/NIRAVATH/PRO00021342)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % IV SOLP (EXCEL;NON-PVC)	QS Base	500 mL	Yes	Yes				Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	NAB-PACLItaxel (ABRAXANE) chemo infusion	Dose: --	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	gemcitabine (GEMZAR) in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	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.
		  	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					Nursing Orders
☑	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
		☑	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
			Labs
☑	TROPONIN	Interval: --	Occurrences: --	Comments:	To be done at 2-3 hours post EOI; may need to repeat in intervals as listed in the protocol if indication of myocardial infarction
			Nursing Orders
☑	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o To be done at end of infusion ONLY if troponin levels indicate myocardial infarction 
o Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Imaging
☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI as appropriate. To be done EVERY 6 weeks during study.
		☐	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or MRI as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated)
o To be done EVERY 6 weeks during study
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or CT as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated) 
o To be done EVERY 6 weeks during study
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201a Study Drug.		☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 10	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Line Flush
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201a Study Drug.		☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with DS8201a Study Drug.			Nursing Orders
☑	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for DS8201a Study Drug		☐	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.  Do NOT administer with DS8201a Study Drug.			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Perform all labs and procedures prior to study med administration unless stated otherwise
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Pre-Medications
◉	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S					Pre-Medications
☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow IV push 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) 50 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 50 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S	End: S 11:45 AM		Instructions:	Administer 30 minutes prior to chemotherapy.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DIPHENHYDRAMINE 50 MG/ML INJECTION SOLUTION	Medications	50 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.			Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Prohibited Medication and Treatments:
o Other anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid, or anticancer hormonal treatment; 
o Other investigational therapeutic agents; 
o Radiotherapy (except for palliative radiation to known metastatic sites as long as it does not affect assessment of response or interrupt treatment for more than the maximum time specified in dose modification section); 
o Radiotherapy to the thorax; 
o Concomitant use of chronic systemic (IV or oral) corticosteroids or other immunosuppressive medications except for managing AEs (inhaled steroids or intraarticular steroid injections are permitted in this study); 
o Subjects with bronchopulmonary disorders who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
			Chemotherapy
◯	INV-DS8201a (DS8201a-U303 study/Niravath/Pro00021342) in dextrose 5% 250 mL IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Infuse via inline filter tubing (use of PAClitaxel tubing is optional). Infuse first dose over 90 minutes. Subsequent doses infused over 30 minutes if no infusion reaction with previous dose. Post infusion, flush line with D5W volume equal to tubing volume. DO NOT use NS. Protect from light.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DS8201A 100 MG SOLUTION FOR INJECTION  (DS8201A-U303 STUDY/NIRAVATH/PRO00021342)	Medications	 	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Nursing Orders
☐	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Verify that the patient has taken oral Xeloda
			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o ALT/AST GREATER than 2.5 times upper normal limit.
			Chemotherapy
☐	INV-Eribulin intravenous push (DS8201a-U303 study/Niravath/pro00021342) injection	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Prepared on/at: _____ expires on/at:____ (4 hours room temperature). Administer as slow inravenous push over 2 to 5 minutes.			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	ondansetron (ZOFRAN) 8 mg, dexamethasone (DECADRON) 20 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 8 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	8 mg	Main Ingredient	Yes	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	20 mg	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	INV-PACLItaxel (DS8201a-U303 study/Niravath/Pro00021342) in sodium chloride (NON-PVC) 0.9 % 500 mL chemo IVPB	Dose: --	Route: intravenous	once over 3 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Prepared on/at:_______ expires on/at:______ (24 hours at room temp). Infuse via 0.22 micro in-line filter over 30 minutes.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PACLITAXEL 6 MG/ML CONCENTRATE,INTRAVENOUS (DS8201A-U303 STUDY/NIRAVATH/PRO00021342)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % IV SOLP (EXCEL;NON-PVC)	QS Base	500 mL	Yes	Yes				Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	NAB-PACLItaxel (ABRAXANE) chemo infusion	Dose: --	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	gemcitabine (GEMZAR) in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	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.
		  	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					Nursing Orders
☑	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
		☑	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
			Labs
☑	TROPONIN	Interval: --	Occurrences: --	Comments:	To be done at 2-3 hours post EOI; may need to repeat in intervals as listed in the protocol if indication of myocardial infarction
			Nursing Orders
☑	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o To be done at end of infusion ONLY if troponin levels indicate myocardial infarction 
o Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201a Study Drug.		☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 11	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Line Flush
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201a Study Drug.		☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with DS8201a Study Drug.			Nursing Orders
☑	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for DS8201a Study Drug		☐	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.  Do NOT administer with DS8201a Study Drug.			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Perform all labs and procedures prior to study med administration unless stated otherwise
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Complete questionnaires (HEOR, EORTC C30 & BR45, and 5L)
			Pre-Medications
◉	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S					Pre-Medications
☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow IV push 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) 50 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 50 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S	End: S 11:45 AM		Instructions:	Administer 30 minutes prior to chemotherapy.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DIPHENHYDRAMINE 50 MG/ML INJECTION SOLUTION	Medications	50 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.			Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Prohibited Medication and Treatments:
o Other anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid, or anticancer hormonal treatment; 
o Other investigational therapeutic agents; 
o Radiotherapy (except for palliative radiation to known metastatic sites as long as it does not affect assessment of response or interrupt treatment for more than the maximum time specified in dose modification section); 
o Radiotherapy to the thorax; 
o Concomitant use of chronic systemic (IV or oral) corticosteroids or other immunosuppressive medications except for managing AEs (inhaled steroids or intraarticular steroid injections are permitted in this study); 
o Subjects with bronchopulmonary disorders who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
			Chemotherapy
◯	INV-DS8201a (DS8201a-U303 study/Niravath/Pro00021342) in dextrose 5% 250 mL IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Infuse via inline filter tubing (use of PAClitaxel tubing is optional). Infuse first dose over 90 minutes. Subsequent doses infused over 30 minutes if no infusion reaction with previous dose. Post infusion, flush line with D5W volume equal to tubing volume. DO NOT use NS. Protect from light.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DS8201A 100 MG SOLUTION FOR INJECTION  (DS8201A-U303 STUDY/NIRAVATH/PRO00021342)	Medications	 	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Nursing Orders
☐	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Verify that the patient has taken oral Xeloda
			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o ALT/AST GREATER than 2.5 times upper normal limit.
			Chemotherapy
☐	INV-Eribulin intravenous push (DS8201a-U303 study/Niravath/pro00021342) injection	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Prepared on/at: _____ expires on/at:____ (4 hours room temperature). Administer as slow inravenous push over 2 to 5 minutes.			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	ondansetron (ZOFRAN) 8 mg, dexamethasone (DECADRON) 20 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 8 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	8 mg	Main Ingredient	Yes	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	20 mg	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	INV-PACLItaxel (DS8201a-U303 study/Niravath/Pro00021342) in sodium chloride (NON-PVC) 0.9 % 500 mL chemo IVPB	Dose: --	Route: intravenous	once over 3 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Prepared on/at:_______ expires on/at:______ (24 hours at room temp). Infuse via 0.22 micro in-line filter over 30 minutes.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PACLITAXEL 6 MG/ML CONCENTRATE,INTRAVENOUS (DS8201A-U303 STUDY/NIRAVATH/PRO00021342)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % IV SOLP (EXCEL;NON-PVC)	QS Base	500 mL	Yes	Yes				Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	NAB-PACLItaxel (ABRAXANE) chemo infusion	Dose: --	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	gemcitabine (GEMZAR) in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	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.
		  	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					Nursing Orders
☑	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
		☑	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
			Labs
☑	TROPONIN	Interval: --	Occurrences: --	Comments:	To be done at 2-3 hours post EOI; may need to repeat in intervals as listed in the protocol if indication of myocardial infarction
			Nursing Orders
☑	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o To be done at end of infusion ONLY if troponin levels indicate myocardial infarction 
o Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Imaging
☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI as appropriate. To be done EVERY 6 weeks during study.
		☐	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or MRI as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated)
o To be done EVERY 6 weeks during study
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or CT as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated) 
o To be done EVERY 6 weeks during study
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201a Study Drug.		☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 12	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Line Flush
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201a Study Drug.		☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with DS8201a Study Drug.			Nursing Orders
☑	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for DS8201a Study Drug		☐	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.  Do NOT administer with DS8201a Study Drug.			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Perform all labs and procedures prior to study med administration unless stated otherwise
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Pre-Medications
◉	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S					Pre-Medications
☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow IV push 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) 50 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 50 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S	End: S 11:45 AM		Instructions:	Administer 30 minutes prior to chemotherapy.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DIPHENHYDRAMINE 50 MG/ML INJECTION SOLUTION	Medications	50 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.			Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Prohibited Medication and Treatments:
o Other anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid, or anticancer hormonal treatment; 
o Other investigational therapeutic agents; 
o Radiotherapy (except for palliative radiation to known metastatic sites as long as it does not affect assessment of response or interrupt treatment for more than the maximum time specified in dose modification section); 
o Radiotherapy to the thorax; 
o Concomitant use of chronic systemic (IV or oral) corticosteroids or other immunosuppressive medications except for managing AEs (inhaled steroids or intraarticular steroid injections are permitted in this study); 
o Subjects with bronchopulmonary disorders who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
			Chemotherapy
◯	INV-DS8201a (DS8201a-U303 study/Niravath/Pro00021342) in dextrose 5% 250 mL IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Infuse via inline filter tubing (use of PAClitaxel tubing is optional). Infuse first dose over 90 minutes. Subsequent doses infused over 30 minutes if no infusion reaction with previous dose. Post infusion, flush line with D5W volume equal to tubing volume. DO NOT use NS. Protect from light.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DS8201A 100 MG SOLUTION FOR INJECTION  (DS8201A-U303 STUDY/NIRAVATH/PRO00021342)	Medications	 	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Nursing Orders
☐	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Verify that the patient has taken oral Xeloda
			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o ALT/AST GREATER than 2.5 times upper normal limit.
			Chemotherapy
☐	INV-Eribulin intravenous push (DS8201a-U303 study/Niravath/pro00021342) injection	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Prepared on/at: _____ expires on/at:____ (4 hours room temperature). Administer as slow inravenous push over 2 to 5 minutes.			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	ondansetron (ZOFRAN) 8 mg, dexamethasone (DECADRON) 20 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 8 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	8 mg	Main Ingredient	Yes	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	20 mg	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	INV-PACLItaxel (DS8201a-U303 study/Niravath/Pro00021342) in sodium chloride (NON-PVC) 0.9 % 500 mL chemo IVPB	Dose: --	Route: intravenous	once over 3 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Prepared on/at:_______ expires on/at:______ (24 hours at room temp). Infuse via 0.22 micro in-line filter over 30 minutes.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PACLITAXEL 6 MG/ML CONCENTRATE,INTRAVENOUS (DS8201A-U303 STUDY/NIRAVATH/PRO00021342)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % IV SOLP (EXCEL;NON-PVC)	QS Base	500 mL	Yes	Yes				Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	NAB-PACLItaxel (ABRAXANE) chemo infusion	Dose: --	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	gemcitabine (GEMZAR) in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	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.
		  	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					Nursing Orders
☑	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
		☑	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
			Labs
☑	TROPONIN	Interval: --	Occurrences: --	Comments:	To be done at 2-3 hours post EOI; may need to repeat in intervals as listed in the protocol if indication of myocardial infarction
			Nursing Orders
☑	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o To be done at end of infusion ONLY if troponin levels indicate myocardial infarction 
o Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201a Study Drug.		☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 13	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Line Flush
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201a Study Drug.		☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with DS8201a Study Drug.			Nursing Orders
☑	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for DS8201a Study Drug		☐	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.  Do NOT administer with DS8201a Study Drug.			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Perform all labs and procedures prior to study med administration unless stated otherwise
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Complete questionnaires (HEOR, EORTC C30 & BR45, and 5L)
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	Or MUGA as appropriate
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	Or Echo as appropriate
			Pre-Medications
◉	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S					Pre-Medications
☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow IV push 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) 50 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 50 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S	End: S 11:45 AM		Instructions:	Administer 30 minutes prior to chemotherapy.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DIPHENHYDRAMINE 50 MG/ML INJECTION SOLUTION	Medications	50 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.			Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Prohibited Medication and Treatments:
o Other anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid, or anticancer hormonal treatment; 
o Other investigational therapeutic agents; 
o Radiotherapy (except for palliative radiation to known metastatic sites as long as it does not affect assessment of response or interrupt treatment for more than the maximum time specified in dose modification section); 
o Radiotherapy to the thorax; 
o Concomitant use of chronic systemic (IV or oral) corticosteroids or other immunosuppressive medications except for managing AEs (inhaled steroids or intraarticular steroid injections are permitted in this study); 
o Subjects with bronchopulmonary disorders who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
			Chemotherapy
◯	INV-DS8201a (DS8201a-U303 study/Niravath/Pro00021342) in dextrose 5% 250 mL IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Infuse via inline filter tubing (use of PAClitaxel tubing is optional). Infuse first dose over 90 minutes. Subsequent doses infused over 30 minutes if no infusion reaction with previous dose. Post infusion, flush line with D5W volume equal to tubing volume. DO NOT use NS. Protect from light.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DS8201A 100 MG SOLUTION FOR INJECTION  (DS8201A-U303 STUDY/NIRAVATH/PRO00021342)	Medications	 	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Nursing Orders
☐	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Verify that the patient has taken oral Xeloda
			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o ALT/AST GREATER than 2.5 times upper normal limit.
			Chemotherapy
☐	INV-Eribulin intravenous push (DS8201a-U303 study/Niravath/pro00021342) injection	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Prepared on/at: _____ expires on/at:____ (4 hours room temperature). Administer as slow inravenous push over 2 to 5 minutes.			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	ondansetron (ZOFRAN) 8 mg, dexamethasone (DECADRON) 20 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 8 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	8 mg	Main Ingredient	Yes	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	20 mg	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	INV-PACLItaxel (DS8201a-U303 study/Niravath/Pro00021342) in sodium chloride (NON-PVC) 0.9 % 500 mL chemo IVPB	Dose: --	Route: intravenous	once over 3 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Prepared on/at:_______ expires on/at:______ (24 hours at room temp). Infuse via 0.22 micro in-line filter over 30 minutes.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PACLITAXEL 6 MG/ML CONCENTRATE,INTRAVENOUS (DS8201A-U303 STUDY/NIRAVATH/PRO00021342)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % IV SOLP (EXCEL;NON-PVC)	QS Base	500 mL	Yes	Yes				Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	NAB-PACLItaxel (ABRAXANE) chemo infusion	Dose: --	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	gemcitabine (GEMZAR) in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	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.
		  	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					Nursing Orders
☑	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
		☑	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
			Labs
☑	TROPONIN	Interval: --	Occurrences: --	Comments:	To be done at 2-3 hours post EOI; may need to repeat in intervals as listed in the protocol if indication of myocardial infarction
			Nursing Orders
☑	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o To be done at end of infusion ONLY if troponin levels indicate myocardial infarction 
o Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Imaging
☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI as appropriate. To be done EVERY 6 weeks during study.
		☐	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or MRI as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated)
o To be done EVERY 6 weeks during study
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or CT as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated) 
o To be done EVERY 6 weeks during study
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201a Study Drug.		☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine injection 500 Units	Dose: 500 Units	Route: intra-catheter	once PRN	Start: S			Instructions:	Concentration: 100 units/mL. Heparin flush for Implanted Vascular Access Device maintenance.					
Cycle 14	Repeat 1 time	Cycle length: 21 days	Day 1	Perform every 1 day x1		Appointment Requests
  	ONC INFUSION APPOINTMENT REQUEST 8	Interval: --	Occurrences: --			Line Flush
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201a Study Drug.		☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Do NOT administer with DS8201a Study Drug.			Nursing Orders
☑	dextrose 5% infusion 250 mL	Dose: 250 mL	Route: intravenous	once @ 30 mL/hr for 1 dose	Start: S			Instructions:	To keep vein open for DS8201a Study Drug		☐	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.  Do NOT administer with DS8201a Study Drug.			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Perform all labs and procedures prior to study med administration unless stated otherwise
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	If childbearing potential
		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Pre-Medications
◉	ondansetron (ZOFRAN) IV 8 mg	Dose: 8 mg	Route: intravenous	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) tablet 16 mg	Dose: 16 mg	Route: oral	once for 1 dose	Start: S				◯	ondansetron (ZOFRAN) IV 16 mg	Dose: 16 mg	Route: intravenous	once for 1 dose	Start: S					Pre-Medications
☐	diphenhydrAMINE (BENADRYL) injection 25 mg	Dose: 25 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer via slow IV push 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) 50 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 50 mg	Route: intravenous	once over 15 Minutes for 1 dose	Start: S	End: S 11:45 AM		Instructions:	Administer 30 minutes prior to chemotherapy.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	DIPHENHYDRAMINE 50 MG/ML INJECTION SOLUTION	Medications	50 mg	Main Ingredient	No	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	Dose: 25 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	diphenhydrAMINE (BENADRYL) tablet 50 mg	Dose: 50 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) injection 20 mg	Dose: 20 mg	Route: intravenous	once for 1 dose	Start: S			Instructions:	Administer 30 minutes prior to chemotherapy.		☐	famotidine (PEPCID) tablet 20 mg	Dose: 20 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.		☐	acetaminophen (TYLENOL) tablet 650 mg	Dose: 650 mg	Route: oral	once for 1 dose			Offset: 0 Hours	Instructions:	Administer 30 minutes prior to chemotherapy.			Supportive Care
◯	LORAZepam (ATIVAN) injection 1 mg	Dose: 1 mg	Route: intravenous	once PRN	Start: S				◯	LORAZepam (ATIVAN) tablet 1 mg	Dose: 1 mg	Route: oral	once PRN	Start: S					Antiemetics
◯	promethazine (PHENERGAN) injection 12.5 mg	Dose: 12.5 mg	Route: injection	once PRN	Start: S					Nursing Orders
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	Prohibited Medication and Treatments:
o Other anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid, or anticancer hormonal treatment; 
o Other investigational therapeutic agents; 
o Radiotherapy (except for palliative radiation to known metastatic sites as long as it does not affect assessment of response or interrupt treatment for more than the maximum time specified in dose modification section); 
o Radiotherapy to the thorax; 
o Concomitant use of chronic systemic (IV or oral) corticosteroids or other immunosuppressive medications except for managing AEs (inhaled steroids or intraarticular steroid injections are permitted in this study); 
o Subjects with bronchopulmonary disorders who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study
			Chemotherapy
◯	INV-DS8201a (DS8201a-U303 study/Niravath/Pro00021342) in dextrose 5% 250 mL IVPB	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Infuse via inline filter tubing (use of PAClitaxel tubing is optional). Infuse first dose over 90 minutes. Subsequent doses infused over 30 minutes if no infusion reaction with previous dose. Post infusion, flush line with D5W volume equal to tubing volume. DO NOT use NS. Protect from light.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-DS8201A 100 MG SOLUTION FOR INJECTION  (DS8201A-U303 STUDY/NIRAVATH/PRO00021342)	Medications	 	Main Ingredient	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes				Nursing Orders
☐	ONC NURSING COMMUNICATION 22	Interval: --	Occurrences: --	Comments:	Verify that the patient has taken oral Xeloda
			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 10	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if 
o ANC LESS than 1000; 
o Platelets LESS than 100,000; 
o ALT/AST GREATER than 2.5 times upper normal limit.
			Chemotherapy
☐	INV-Eribulin intravenous push (DS8201a-U303 study/Niravath/pro00021342) injection	Dose: --	Route: intravenous	once for 1 dose			Offset: 30 Minutes	Instructions:	Prepared on/at: _____ expires on/at:____ (4 hours room temperature). Administer as slow inravenous push over 2 to 5 minutes.			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	ondansetron (ZOFRAN) 8 mg, dexamethasone (DECADRON) 20 mg in sodium chloride 0.9% 50 mL IVPB	Dose: 8 mg	Route: intravenous	once over 10 Minutes for 1 dose	Start: S			Ingredients:	Name	Type	Dose	Selected	Adds Vol.	ONDANSETRON HCL 2 MG/ML INTRAVENOUS SOLUTION	Medications	8 mg	Main Ingredient	Yes	DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTION SOLUTION	Medications	20 mg	Yes	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	Base	50 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	Base	50 mL	No	Yes			☐	INV-PACLItaxel (DS8201a-U303 study/Niravath/Pro00021342) in sodium chloride (NON-PVC) 0.9 % 500 mL chemo IVPB	Dose: --	Route: intravenous	once over 3 Hours for 1 dose			Offset: 30 Minutes	Instructions:	Prepared on/at:_______ expires on/at:______ (24 hours at room temp). Infuse via 0.22 micro in-line filter over 30 minutes.	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	INV-PACLITAXEL 6 MG/ML CONCENTRATE,INTRAVENOUS (DS8201A-U303 STUDY/NIRAVATH/PRO00021342)	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % IV SOLP (EXCEL;NON-PVC)	QS Base	500 mL	Yes	Yes				Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	NAB-PACLItaxel (ABRAXANE) chemo infusion	Dose: --	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes			Outpatient Electrolyte Replacement Protocol
☐	TREATMENT CONDITIONS 39	Interval: --	Occurrences: --	Comments:	Potassium (Normal range 3.5 to 5.0mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum potassium less than 3.0mEq/L, give 40mEq KCL IV or PO and contact MD/NP
o	Serum potassium 3.0 to 3.2mEq/L, give 40mEq KCL IV or PO
o	Serum potassium 3.3 to 3.4mEq/L, give 20mEq KCL IV or PO
o	Serum potassium 3.5 mEq/L or greater, do not give potassium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
		☐	TREATMENT CONDITIONS 40 	Interval: --	Occurrences: --	Comments:	Magnesium (Normal range 1.6 to 2.6mEq/L)
o	Protocol applies for SCr less than 1.5. Otherwise, contact MD/NP
o	Protocol applies only to same day lab value.  
o	Serum Magnesium less than 1.0mEq/L, give 2 gram magnesium sulfate IV and contact MD/NP
o	Serum Magnesium 1.0 to 1.2mEq/L, give 2 gram magnesium sulfate IV 
o	Serum Magnesium 1.3 to 1.5mEq/L, give 1 gram magnesium sulfate IV
o	Serum Magnesium 1.6 mEq/L or greater, do not give magnesium replacement
o	If patient meets criteria, order SmartSet called "Outpatient Electrolyte Replacement"
o	Sign electrolyte replacement order as Per protocol: cosign required
			Nursing Orders
☐	TREATMENT CONDITIONS 7	Interval: --	Occurrences: --	Comments:	HOLD and notify provider if ANC LESS than 1000; Platelets LESS than 100,000.
			Chemotherapy
☐	gemcitabine (GEMZAR) in sodium chloride 0.9% 250 mL chemo IVPB	Dose: --	Route: intravenous	once over 30 Minutes for 1 dose			Offset: 30 Minutes	Ingredients:	Name	Type	Dose	Selected	Adds Vol.	GEMCITABINE 200 MG/5.26 ML (38 MG/ML) INTRAVENOUS SOLUTION	Medications	 	Main Ingredient	Yes	SODIUM CHLORIDE 0.9 % INTRAVENOUS SOLUTION	QS Base	250 mL	Yes	Yes	DEXTROSE 5 % IN WATER (D5W) INTRAVENOUS SOLUTION	QS Base	 	No	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.
		  	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					Nursing Orders
☑	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
		☑	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --	Comments:	To be performed at end of infusion
			Labs
☑	TROPONIN	Interval: --	Occurrences: --	Comments:	To be done at 2-3 hours post EOI; may need to repeat in intervals as listed in the protocol if indication of myocardial infarction
			Nursing Orders
☑	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	o To be done at end of infusion ONLY if troponin levels indicate myocardial infarction 
o Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Discharge Nursing Orders
  	ONC NURSING COMMUNICATION 76	Interval: --	Occurrences: --	Comments:	Discontinue IV.
			Discharge Nursing Orders
☑	dextrose 5% flush syringe 20 mL	Dose: 20 mL	Route: intravenous	PRN	Start: S			Instructions:	Administer ONLY for DS8201a Study Drug.		☐	sodium chloride 0.9% flush 20 mL	Dose: 20 mL	Route: intravenous	PRN					☑	HEParin, porcine 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.					
30-Days End of Treatment (+/- 7 days or +7 days if study treatment discontinue)	Repeat 1 time	Cycle length: 10 days	Day 1	Perform every 1 day x1		Nursing Orders
  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	TROPONIN	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Triplicate; initiated LESS than or EQUAL to 3 min apart, while in a supine/semi-recumbent position
			Miscellaneous
  	VISUAL ACUITY SCREENING	Interval: --	Occurrences: --		  	SLIT LAMP PHOTOGRAPHY - OU - BOTH EYES	Interval: --	Occurrences: --		  	FUNDUS PHOTOS - OU - BOTH EYES	Interval: --	Occurrences: --	Comments:	Fundoscopy
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Complete questionnaires (HEOR, EORTC C30 & BR45, and 5L)
			Imaging
◉	TRANSTHORACIC ECHOCARDIOGRAM COMPLETE W CONT STRAIN 3D IF NEEDED	Interval: --	Occurrences: --	Comments:	Or MUGA as appropriate
		◯	NM RADIONUCLIDE ANGIOGRAPHY (MUGA) RESTING ONLY	Interval: --	Occurrences: --	Comments:	Or Echo as appropriate
			Imaging
☑	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or MRI as appropriate. To be done EVERY 6 weeks during study.
		☐	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or MRI as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated)
o To be done EVERY 6 weeks during study
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	Or CT as appropriate. To be done EVERY 6 weeks during study.
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	o Or CT as appropriate 
o Only for subjects with baseline stable brain WITH contrastmetastases or clinically indicated) 
o To be done EVERY 6 weeks during study
					
40-Day Follow Up:  (+7 d) 	Repeat 1 time	Cycle length: 7 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	40-day follow up to be scheduled AFTER last study treatment administration or prior to new anticancer treatment. If EOT is GREATER than 40 days after last treatment, then the EOT assessments do not need repeated at this visit.
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	PULSE OXIMETRY	Interval: --	Occurrences: --		  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Physical exam
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	TROPONIN	Interval: --	Occurrences: --		  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Complete questionnaires (HEOR, EORTC C30 & BR45, and 5L)
					
Long Term follow up (+ 7 days from 40-Day visit)	Repeat 1 time	Cycle length: 90 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Long term follow up is to be repeated every 3 months (+/-14 days until death/withdraw consent/study closure/or loss to follow-up). Please schedule patient accordingly.
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Complete Survivor Follow-up Documentation: Record new or current anticancer treatments, outcomes, and survival
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Complete questionnaires (HEOR, EORTC C30 & BR45, and 5L)