Adult Dosing
Asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer
- 1 dose [250 mL] IV infusion over 60 minutes q2 wks x3 doses
Notes:- Indicated for autologous use only
- For IV administration only; do not use a cell filter
- Prior to infusion, ensure that the patient’s identity matches with the patient identifiers on the cell product disposition form and the infusion bag
- Each dose of sipuleucel-T requires a standard leukapheresis 3 days prior to infusion. If the patient is unable to receive a scheduled infusion, the patient should undergo an additional leukapheresis if the course of treatment is to be continued
- Premedicate patients orally with acetaminophen and antihistamine approximately 30 min prior to administration
- Monitor patients closely for 30 minutes following administration for infusion reactions
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Sipuleucel-T is indicated for autologous use only
- Acute infusion reactions such as fever, chills, respiratory events, nausea, vomiting, fatigue, hypertension, and tachycardia have been reported following sipuleucel-T infusion. If an acute infusion reaction occurs, decrease the rate of infusion or discontinue therapy and initiate appropriate medical treatment
- HCPs handling sipuleucel-T are at a risk of transmission of infectious diseases, as the product is not routinely tested for transmissible infectious agents. Caution is advised during handling
- Safety and efficacy of sipuleucel-T may be altered with concomitant use of chemotherapy or immunosuppressive agents. Evaluate patients before making any decision to reduce/discontinue immunosuppressive agents prior to sipuleucel-T therapy
- Sipuleucel-T is released for infusion following the microbial and sterility results from several tests. Final sterility test results are not available at the time of infusion; however, in case of positive microbial contamination, the manufacturer will identify the microorganism and notify the results to the treating physician
Cautions: Use cautiously in
- Cardiac diseases
- Pulmonary conditions
Supplemental Patient Information
- Inform patients regarding the need for a central venous catheter, if there is no adequate peripheral venous access to accommodate leukapheresis and sipuleucel-T infusion. Emphasize the importance of catheter care and instruct patients to report their physicians if they experience any fever, swelling or redness around the catheter site
- Advise patients to promptly report any symptoms suggestive of a cardiac arrhythmia
Pregnancy Category: Not Applicable
Breastfeeding: Not Applicable
