IV Administration:

• Each infusion must be preceded by a leukaphresis procedure approximately 3 days prior. If patient is unable to receive an infusion, patient will need to undergo an additional leukaphresis procedure.
• Medication is not routinely tested for transmissible infectious diseases. Employ universal precautions in handling leukapheresis material or sipuleucel.
• Premedicate patient with acetaminophen and an antihistamine (diphenhydramine) 30 min prior to administration to minimize acute infusion reactions.
• Upon receipt of sipuleucel from manufacturer, open outer cardboard shipping box to verify product and patient-specific labels. Do not remove insulated container from shipping box or open lid of insulated container until patient is ready for infusion. Do not infuse until confirmation of product release has been received from manufacturer.
• Infusion must begin prior to expiration date and time. Do not infuse expired sipuleucel. Once infusion bag is removed from insulated container, infuse within 3 hr; do not return to shipping container.
• Intermittent Infusion: Once patient is prepared for infusion and Cell Product Disposition Form has been received, remove infusion bag from insulated container, and inspect bag for leakage. Contents will be slightly cloudy, with cream-to-pink color. Gently mix and re-suspend contents of bag, inspecting for clumps and clots. Small clumps should disperse with gentle manual mixing; do not administer if bag leaks or if clumps remain.
• Sipuleucel is solely for autologous use. Match patient's identity with the patient identifiers on the Cell Product Disposition Form and infusion bag.
• Rate: Infuse the entire volume of the bag over 60 min. Do not use a cell filter.