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CSC GU Sipuleucel-T VER 12-1-16 (HL 5133)

CSC GU Sipuleucel-T VER 12-1-16 (HL 5133) - Clinical Hub, UW Health Clinical Tool Search, UW Health Clinical Tool Search, Beacon Protocols, GU


CSC GU SIPULEUCEL-T VER: 12-1-16 (HL 5133) – Properties
Pre-Cycle – 6/8/2017 through 6/14/2017 (7 days), Planned
Day 1, Pre-Cycle – Planned for 6/8/2017
Treatment Plan Information
Treatment Plan Summary
DISEASE: Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant (hormone refractory) Prostate Cancer; THERAPY:
sipuleucel-T IV Day 4 (48 to 72 hours post leukapheresis at the Red Cross); CYCLE LENGTH: 14 days; COURSE: 3 cycles.
Consent
Verify Consent
Verify informed consent has been obtained.
Pre-Labs
CBC WITH DIFFERENTIAL
Expected-S Approximate, Expires-S+365, Routine
Take Home Medications
acetaMINOPHEN (TYLENOL) 325 MG tab
Take 2 tabs by mouth every 4 hours as needed (body aches and/ or joint pain. No more than 4 grams in 24 hours)., 650 mg, Disp-
100 tab, R-0, EVERY 4 HOURS PRN starting S, No Print
Cycle 1 – 6/15/2017 through 6/28/2017 (14 days), Planned
DAY 4 (WEEK 1), Cycle 1 – Planned for 6/15/2017
Treatment Plan Information
Reference Information (1)
METASTATIC CASTRATE RESISTANT PROSTATE CANCER: Kantoff P, et al. N Engl J Med 2010; 363:411-22.
Treatment Plan Summary
DISEASE: Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant (hormone refractory) Prostate Cancer; THERAPY:
sipuleucel-T IV Day 4 (48 to 72 hours post leukapheresis at the Red Cross); CYCLE LENGTH: 14 days; COURSE: 3 cycles.
Consent
Verify Consent
Verify informed consent has been obtained.
IV Access
Insert and Maintain Peripheral IV
CONTINUOUS Starting when released Until Specified
Peripheral IV Size: RN Discretion
Additional PIV may be inserted as needed for repeat blood sampling or IV medication administration.
Treatment Conditions
Verify Labs
Verify pretreatment labs have been obtained within the past 4 weeks: CBC with DIFF, PSA (Total, Diagnostic), Alkaline
Phosphatase, LDH, Creatinine and AST.
Treatment Parameters
Hold treatment and notify authorizing prescriber for Hematocrit less than 30% or Platelets less than 100K/uL.
Nursing Procedure, Assessment and Monitoring
Hypersensitivity Monitoring (1)
Acute infusion reactions to sipuleucel-T can occur during and up to 1 day post infusion. For all infusions, patient should be treated in
a location to optimize emergency care. In the event of an acute infusion reaction, decrease the infusion rate and/or stop the infusion
depending on the severity of the reaction. Page MD if rigors do not resolve. Observe patients for a minimum of 30 minutes following
each infusion to monitor for acute infusion reactions. Page ordering physician for any problems, questions or concerns during
administration or monitoring.
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Zztestonc,Jeff J [2507481]
6/15/2017 8:02:41 AM Page 1 of 7
Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised:
 
06/2017CCKM@uwhealth.org

Vital Signs
ONCE Starting when released
Obtain blood pressure, heart rate, respiratory rate and temperature at the start of the infusion, at the end of the
infusion, and at the end of the 30 minute monitoring period.
Patient Instructions(1)
Remind patient to call the Cancer Clinic at 265-1700 to report fever over 101 degrees F, redness at the cell collection or infusion
sites, back pain, joint ache, and headache not relieved with acetaminophen (Tylenol).
Nursing Communication
SEE COMMENTS Starting when released Until Specified
For vascular access: a large-bore IV line suitable for blood transfusions should be used: 18 to 20 gauge is recommended, 22 gauge
is acceptable.
Flush Venous Access Device per Guidelines
Order details
sodium chloride flush 0.9% 10 mL injection
Flush, PRN Starting when released Until Discontinued, flush/line care
Flush per VAD guidelines.
heparin lock flush 10 UNIT/ML injection 1-150 units
1-150 units, Flush, PRN Starting when released Until Discontinued, flush/line care
Flush per VAD guidelines.
heparin 100 UNIT/ML lock flush injection 500 units
500 units, Flush, PRN Starting when released Until Discontinued, flush/line care
Implanted port use ONLY to be used when de-accessing port. Flush per VAD guidelines.
Hydration
sodium chloride 0.9 % infusion
at 20 mL/hr, Intravenous, ONCE, 1 dose Starting when released
To establish line and for flushing.
Pre-Medications
acetaMINOPHEN (TYLENOL) tab 650 mg
650 mg, Oral, ONCE, 1 dose Starting when released
Give 30 minutes prior to start of infusion.
diphenhydramine (BENADRYL) cap 50 mg
50 mg, Oral, ONCE, 1 dose Starting when released
Give 30 minutes prior to start of infusion.
Emergency Medications
Note to All Staff (1)
Steroids (dexamethasone, hydrocortisone, etc.) are NOT allowed in the treatment of infusion related reactions.
ranitidine (ZANTAC) injection 50 mg
50 mg, Intravenous, PRN, 1 dose Starting when released, infusion reaction, Administer over 5 Minutes
infusion reaction (give first)
diphenhydramine (BENADRYL) injection 25 mg
25 mg, Intravenous, PRN, 1 dose Starting when released, infusion reaction, Administer over 1 Minutes
diphenhydramine (BENADRYL) injection 50 mg
50 mg, Intravenous, PRN, 1 dose Starting when released, infusion reaction, Administer over 1 Minutes
albuterol 2.5 mg/3 mL neb soln
2.5 mg, Nebulization, PRN, 1 dose Starting when released, infusion reaction
Treatment Medications
NOTE:
ONCE, 1 dose Starting when released
Sipuleucel-T in 250 mL LR IV over 60 to 90 min. Hypersensitivity Risk. See Emergency Medications. Acute infusion reactions to
sipuleucel-T can occur during and up to 1 day post infusion. For all infusions, patient should be treated in a location to optimize
emergency care. In the event of an acute infusion reaction, decrease the infusion rate and/or stop the infusion depending on the
severity of the reaction. Page MD if rigors do not resolve. Observe patients for a minimum of 30 minutes following each infusion to
monitor for acute infusion reactions. Page ordering physician for any problems, questions or concerns during administration or
monitoring. The Cell Product Disposition form must be received and marked "Approved" before the infusion begins. Immediately
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Zztestonc,Jeff J [2507481]
6/15/2017 8:02:41 AM Page 2 of 7
Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised:
 
06/2017CCKM@uwhealth.org

prior to infusion, 2 RNs confirm that the patient's identity matches the patient identifiers on the Cell Product Disposition Form and on
the sipuleucel-T infusion bag, and document this on the Product Verification Form-Sipuleucel-T. Do not use a cell filter during the
infusion. Inspect the bag for signs of leakage and gently mix and re-suspend the contents of the bag, inspecting for clumps and
clots. Do not administer if the bag leaks or if clumps remain in the bag. Do not initiate infusion of expired sipuleucel-T. If infusion is
slowed or stopped, it should not be resumed if the sipuleucel-T bag will be held at room temperature for more than 3 hours.
Follow-Up
DAY 8 FOLLOW-UP
Mid Cycle (Week 2). RETURN TO CLINIC for appointment with provider; LABS: CBC with DIFF and Creatinine.
DAY 15 FOLLOW-UP
Verify that cell collection has occured at the Red Cross.
DAY 18 FOLLOW-UP
Cycle 2 (Week 3) Day 4. LABS: CBC with DIFF and Creatinine. INFUSION CENTER APPOINTMENT: sipuleucel-T for 180 minutes.
DAY 8 LAB ONLY DAY (WEEK 2), Cycle 1 – Planned for 6/22/2017
Treatment Plan Information
Treatment Plan Summary
DISEASE: Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant (hormone refractory) Prostate Cancer; THERAPY:
sipuleucel-T IV Day 4 (48 to 72 hours post leukapheresis at the Red Cross); CYCLE LENGTH: 14 days; COURSE: 3 cycles.
Pre-Labs
CBC WITH DIFFERENTIAL
Expected-S+4 Approximate, Expires-S+365, Routine
CREATININE
Expected-S+4 Approximate, Expires-S+365, Routine
Follow-Up
VERIFY APPOINTMENTS
Verify next day appointment(s) have been scheduled. See follow-up section on Day 4.
Cycle 2 – 6/29/2017 through 7/12/2017 (14 days), Planned
DAY 4 (WEEK 3), Cycle 2 – Planned for 6/29/2017
Treatment Plan Information
Treatment Plan Summary
DISEASE: Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant (hormone refractory) Prostate Cancer; THERAPY:
sipuleucel-T IV Day 4 (48 to 72 hours post leukapheresis at the Red Cross); CYCLE LENGTH: 14 days; COURSE: 3 cycles.
Consent
Verify Consent
Verify informed consent has been obtained.
IV Access
Insert and Maintain Peripheral IV
CONTINUOUS Starting when released Until Specified
Peripheral IV Size: RN Discretion
Additional PIV may be inserted as needed for repeat blood sampling or IV medication administration.
Pre-Labs
CBC WITH DIFFERENTIAL
Expected-S+14 Approximate, Expires-S+365, Routine
CREATININE
Expected-S+14 Approximate, Expires-S+365, Routine
Treatment Conditions
Verify Labs
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Zztestonc,Jeff J [2507481]
6/15/2017 8:02:41 AM Page 3 of 7
Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised:
 
06/2017CCKM@uwhealth.org

Verify pretreatment labs have been obtained: CBC with DIFF and Creatinine.
Treatment Parameters
Hold treatment and notify authorizing prescriber for Hematocrit less than 30% or Platelets less than 100K/uL.
Nursing Procedure, Assessment and Monitoring
Hypersensitivity Monitoring (1)
Acute infusion reactions to sipuleucel-T can occur during and up to 1 day post infusion. For all infusions, patient should be treated in
a location to optimize emergency care. In the event of an acute infusion reaction, decrease the infusion rate and/or stop the infusion
depending on the severity of the reaction. Page MD if rigors do not resolve. Observe patients for a minimum of 30 minutes following
each infusion to monitor for acute infusion reactions. Page ordering physician for any problems, questions or concerns during
administration or monitoring.
Vital Signs
ONCE Starting when released
Obtain blood pressure, heart rate, respiratory rate and temperature at the start of the infusion, at the end of the infusion, and at the
end of the 30 minute monitoring period.
Patient Instructions(1)
Remind patient to call the Cancer Clinic at 265-1700 to report fever over 101 degrees F, redness at the cell collection or infusion
sites, back pain, joint ache, and headache not relieved with acetaminophen (Tylenol).
Nursing Communication
SEE COMMENTS Starting when released Until Specified
For vascular access: a large-bore IV line suitable for blood transfusions should be used: 18 to 20 gauge is recommended, 22 gauge
is acceptable.
Flush Venous Access Device per Guidelines
Order details
sodium chloride flush 0.9% 10 mL injection
Flush, PRN Starting when released Until Discontinued, flush/line care
Flush per VAD guidelines.
heparin lock flush 10 UNIT/ML injection 1-150 units
1-150 units, Flush, PRN Starting when released Until Discontinued, flush/line care
Flush per VAD guidelines.
heparin 100 UNIT/ML lock flush injection 500 units
500 units, Flush, PRN Starting when released Until Discontinued, flush/line care
Implanted port use ONLY to be used when de-accessing port. Flush per VAD guidelines.
Hydration
sodium chloride 0.9 % infusion
at 20 mL/hr, Intravenous, ONCE, 1 dose Starting when released
To establish line and for flushing.
Pre-Medications
acetaMINOPHEN (TYLENOL) tab 650 mg
650 mg, Oral, ONCE, 1 dose Starting when released
Give 30 minutes prior to start of infusion.
diphenhydramine (BENADRYL) cap 50 mg
50 mg, Oral, ONCE, 1 dose Starting when released
Give 30 minutes prior to start of infusion.
Emergency Medications
Note to All Staff (1)
Steroids (dexamethasone, hydrocortisone, etc.) are NOT allowed in the treatment of infusion related reactions.
ranitidine (ZANTAC) injection 50 mg
50 mg, Intravenous, PRN, 1 dose Starting when released, infusion reaction, Administer over 5 Minutes
infusion reaction (give first)
diphenhydramine (BENADRYL) injection 25 mg
25 mg, Intravenous, PRN, 1 dose Starting when released, infusion reaction, Administer over 1 Minutes
diphenhydramine (BENADRYL) injection 50 mg
50 mg, Intravenous, PRN, 1 dose Starting when released, infusion reaction, Administer over 1 Minutes
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Zztestonc,Jeff J [2507481]
6/15/2017 8:02:41 AM Page 4 of 7
Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised:
 
06/2017CCKM@uwhealth.org

albuterol 2.5 mg/3 mL neb soln
2.5 mg, Nebulization, PRN, 1 dose Starting when released, infusion reaction
Treatment Medications
NOTE:
ONCE, 1 dose Starting when released
Sipuleucel-T in 250 mL LR IV over 60 to 90 min. Hypersensitivity Risk. See Emergency Medications. Acute infusion reactions to
sipuleucel-T can occur during and up to 1 day post infusion. For all infusions, patient should be treated in a location to optimize
emergency care. In the event of an acute infusion reaction, decrease the infusion rate and/or stop the infusion depending on the
severity of the reaction. Page MD if rigors do not resolve. Observe patients for a minimum of 30 minutes following each infusion to
monitor for acute infusion reactions. Page ordering physician for any problems, questions or concerns during administration or
monitoring. The Cell Product Disposition form must be received and marked "Approved" before the infusion begins. Immediately
prior to infusion, 2 RNs confirm that the patient's identity matches the patient identifiers on the Cell Product Disposition Form and on
the sipuleucel-T infusion bag, and document this on the Product Verification Form-Sipuleucel-T. Do not use a cell filter during the
infusion. Inspect the bag for signs of leakage and gently mix and re-suspend the contents of the bag, inspecting for clumps and
clots. Do not administer if the bag leaks or if clumps remain in the bag. Do not initiate infusion of expired sipuleucel-T. If infusion is
slowed or stopped, it should not be resumed if the sipuleucel-T bag will be held at room temperature for more than 3 hours.
Follow-Up
DAY 22 FOLLOW-UP
Mid Cycle (Week 4). RETURN TO CLINIC for appointment with provider; LABS: CBC with DIFF, PSA, Alkaline Phosphatase, LDH,
Creatinine and AST.
DAY 29 FOLLOW-UP
Verify that cell collection has occured at the Red Cross.
DAY 32 FOLLOW-UP
Cycle 3 (Week 5) Day 4. LABS: CBC with DIFF, PSA, Alkaline Phosphatase, LDH, Creatinine and AST; INFUSION CENTER
APPOINTMENT: sipuleucel-T for 180 minutes.
DAY 22 LAB ONLY DAY (WEEK 4), Cycle 2 – Planned for 7/2/2017
Treatment Plan Information
Treatment Plan Summary
DISEASE: Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant (hormone refractory) Prostate Cancer; THERAPY:
sipuleucel-T IV Day 4 (48 to 72 hours post leukapheresis at the Red Cross); CYCLE LENGTH: 14 days; COURSE: 3 cycles.
Pre-Labs
CBC WITH DIFFERENTIAL
Expected-S+4 Approximate, Expires-S+365, Routine
PSA TOTAL, DIAGNOSTIC
Expected-S+4 Approximate, Expires-S+365, Routine
ALKALINE PHOSPHATASE
Expected-S+4 Approximate, Expires-S+365, Routine
LD, TOTAL
Expected-S+4 Approximate, Expires-S+365, Routine
CREATININE
Expected-S+4 Approximate, Expires-S+365, Routine
AST/SGOT
Expected-S+4 Approximate, Expires-S+365, Routine
Follow-Up
VERIFY APPOINTMENTS
Verify next day appointment(s) have been scheduled. See follow-up section on Day 4.
Cycle 3 – 7/13/2017 through 7/26/2017 (14 days), Planned
DAY 4 (WEEK 5), Cycle 3 – Planned for 7/13/2017
Treatment Plan Information
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Zztestonc,Jeff J [2507481]
6/15/2017 8:02:41 AM Page 5 of 7
Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised:
 
06/2017CCKM@uwhealth.org

Treatment Plan Summary
DISEASE: Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant (hormone refractory) Prostate
Cancer; THERAPY: sipuleucel-T IV Day 4 (48 to 72 hours post leukapheresis at the Red Cross); CYCLE LENGTH:
14 days; COURSE: 3 cycles.
Consent
Verify Consent
Verify informed consent has been obtained.
IV Access
Insert and Maintain Peripheral IV
CONTINUOUS Starting when released Until Specified
Peripheral IV Size: RN Discretion
Additional PIV may be inserted as needed for repeat blood sampling or IV medication administration.
Pre-Labs
CBC WITH DIFFERENTIAL
Expected-S+14 Approximate, Expires-S+365, Routine
PSA TOTAL, DIAGNOSTIC
Expected-S+14 Approximate, Expires-S+365, Routine
ALKALINE PHOSPHATASE
Expected-S+14 Approximate, Expires-S+365, Routine
LD, TOTAL
Expected-S+14 Approximate, Expires-S+365, Routine
CREATININE
Expected-S+14 Approximate, Expires-S+365, Routine
AST/SGOT
Expected-S+14 Approximate, Expires-S+365, Routine
Treatment Conditions
Verify Labs
Verify pretreatment labs have been obtained: CBC with DIFF, PSA (Total, Diagnostic), Alkaline Phosphatase, LDH, Creatinine and
AST.
Treatment Parameters
Hold treatment and notify authorizing prescriber for Hematocrit less than 30% or Platelets less than 100K/uL.
Nursing Procedure, Assessment and Monitoring
Hypersensitivity Monitoring (1)
Acute infusion reactions to sipuleucel-T can occur during and up to 1 day post infusion. For all infusions, patient should be treated in
a location to optimize emergency care. In the event of an acute infusion reaction, decrease the infusion rate and/or stop the infusion
depending on the severity of the reaction. Page MD if rigors do not resolve. Observe patients for a minimum of 30 minutes following
each infusion to monitor for acute infusion reactions. Page ordering physician for any problems, questions or concerns during
administration or monitoring.
Vital Signs
ONCE Starting when released
Obtain blood pressure, heart rate, respiratory rate and temperature at the start of the infusion, at the end of the infusion, and at the
end of the 30 minute monitoring period.
Patient Instructions(1)
Remind patient to call the Cancer Clinic at 265-1700 to report fever over 101 degrees F, redness at the cell collection or infusion
sites, back pain, joint ache, and headache not relieved with acetaminophen (Tylenol).
Nursing Communication
SEE COMMENTS Starting when released Until Specified
For vascular access: a large-bore IV line suitable for blood transfusions should be used: 18 to 20 gauge is recommended, 22 gauge
is acceptable.
Flush Venous Access Device per Guidelines
Order details
sodium chloride flush 0.9% 10 mL injection
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Zztestonc,Jeff J [2507481]
6/15/2017 8:02:41 AM Page 6 of 7
Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised:
 
06/2017CCKM@uwhealth.org

Flush, PRN Starting when released Until Discontinued, flush/line care
Flush per VAD guidelines.
heparin lock flush 10 UNIT/ML injection 1-150 units
1-150 units, Flush, PRN Starting when released Until Discontinued, flush/line care
Flush per VAD guidelines.
heparin 100 UNIT/ML lock flush injection 500 units
500 units, Flush, PRN Starting when released Until Discontinued, flush/line care
Implanted port use ONLY to be used when de-accessing port. Flush per VAD guidelines.
Hydration
sodium chloride 0.9 % infusion
at 20 mL/hr, Intravenous, ONCE, 1 dose Starting when released
To establish line and for flushing.
Pre-Medications
acetaMINOPHEN (TYLENOL) tab 650 mg
650 mg, Oral, ONCE, 1 dose Starting when released
Give 30 minutes prior to start of infusion.
diphenhydramine (BENADRYL) cap 50 mg
50 mg, Oral, ONCE, 1 dose Starting when released
Give 30 minutes prior to start of infusion.
Emergency Medications
Note to All Staff (1)
Steroids (dexamethasone, hydrocortisone, etc.) are NOT allowed in the treatment of infusion related reactions.
ranitidine (ZANTAC) injection 50 mg
50 mg, Intravenous, PRN, 1 dose Starting when released, infusion reaction, Administer over 5 Minutes
infusion reaction (give first)
diphenhydramine (BENADRYL) injection 25 mg
25 mg, Intravenous, PRN, 1 dose Starting when released, infusion reaction, Administer over 1 Minutes
diphenhydramine (BENADRYL) injection 50 mg
50 mg, Intravenous, PRN, 1 dose Starting when released, infusion reaction, Administer over 1 Minutes
albuterol 2.5 mg/3 mL neb soln
2.5 mg, Nebulization, PRN, 1 dose Starting when released, infusion reaction
Treatment Medications
NOTE:
ONCE, 1 dose Starting when released
Sipuleucel-T in 250 mL LR IV over 60 to 90 min. Hypersensitivity Risk. See Emergency Medications. Acute infusion reactions to
sipuleucel-T can occur during and up to 1 day post infusion. For all infusions, patient should be treated in a location to optimize
emergency care. In the event of an acute infusion reaction, decrease the infusion rate and/or stop the infusion depending on the
severity of the reaction. Page MD if rigors do not resolve. Observe patients for a minimum of 30 minutes following each infusion to
monitor for acute infusion reactions. Page ordering physician for any problems, questions or concerns during administration or
monitoring. The Cell Product Disposition form must be received and marked "Approved" before the infusion begins. Immediately
prior to infusion, 2 RNs confirm that the patient's identity matches the patient identifiers on the Cell Product Disposition Form and on
the sipuleucel-T infusion bag, and document this on the Product Verification Form-Sipuleucel-T. Do not use a cell filter during the
infusion. Inspect the bag for signs of leakage and gently mix and re-suspend the contents of the bag, inspecting for clumps and
clots. Do not administer if the bag leaks or if clumps remain in the bag. Do not initiate infusion of expired sipuleucel-T. If infusion is
slowed or stopped, it should not be resumed if the sipuleucel-T bag will be held at room temperature for more than 3 hours.
Follow-Up
VERIFY APPOINTMENTS
Verify next day appointment(s) have been scheduled. See follow-up section on Day 4.
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Zztestonc,Jeff J [2507481]
6/15/2017 8:02:41 AM Page 7 of 7
Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised:
 
06/2017CCKM@uwhealth.org