Generic name: SIPULEUCEL-T 500000001
Dosage form: injection
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For Autologous Use Only.
For Intravenous Use Only. Do Not Use a Cell Filter.
Do Not Initiate Infusion of Expired Product.
Dose and Schedule
Each dose of PROVENGE contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF [see Description (11)].
The recommended course of therapy for PROVENGE is 3 complete doses, given at approximately 2-week intervals. In controlled clinical trials, the median dosing interval between infusions was 2 weeks (range 1 to 15 weeks); the maximum dosing interval has not been established.
If, for any reason, the patient is unable to receive a scheduled infusion of PROVENGE, the patient will need to undergo an additional leukapheresis procedure if the course of treatment is to be continued. Patients should be advised of this possibility prior to initiating treatment.
To minimize potential acute infusion reactions such as chills and/or fever, it is recommended that patients be premedicated orally with acetaminophen and an antihistamine such as diphenhydramine approximately 30 minutes prior to administration of PROVENGE [see Warnings and Precautions (5.1)].
Handling Precautions for Control of Infectious Disease
PROVENGE is not routinely tested for transmissible infectious diseases. Therefore, patient leukapheresis material and PROVENGE may carry the risk of transmitting infectious diseases to health care professionals handling the product. Employ universal precautions in handling leukapheresis material or PROVENGE. [See How Supplied/Storage and Handling (16).]
The PROVENGE infusion bag must remain within the insulated polyurethane container until the time of administration. Do not remove the insulated polyurethane container from the outer cardboard shipping box. [See How Supplied/Storage and Handling (16).]
Confirm Product Release Before Infusion
Do not infuse PROVENGE until confirmation of product release has been received from Dendreon. Dendreon will send a Cell Product Disposition Form containing the patient identifiers, expiration date and time, and the disposition status (approved for infusion or rejected), to the infusion site. [See How Supplied/Storage and Handling (16).]
Preparation for Infusion
See How Supplied/Storage and Handling (16) for full handling instructions.
Confirm Patient Identity
PROVENGE is intended solely for autologous use. Confirm the proper product has been received according to the label on the outside of the insulated polyurethane container. Prior to PROVENGE infusion, match the patient's identity with the patient identifiers on the Cell Product Disposition Form and the PROVENGE infusion bag.
Inspect the Infusion Bag
Remove the infusion bag from the insulated polyurethane container and inspect the bag for signs of leakage. Do not administer if the bag leaks.
Contents of the bag will be slightly cloudy, with a cream-to-pink color. Gently mix and re-suspend the contents of the bag, inspecting for clumps and clots. Small clumps of cellular material should disperse with gentle manual mixing. Do not administer if the bag leaks during handling or if clumps remain in the bag.
Infusion must begin prior to the expiration date and time indicated on the Cell Product Disposition Form and Product Label. Do not initiate infusion of expired PROVENGE.
Administer PROVENGE via intravenous infusion over a period of approximately 60 minutes. Do not use a cell filter. PROVENGE is supplied in a sealed, patient-specific infusion bag; the entire volume of the bag should be infused.
Observe the patient for at least 30 minutes following each infusion.
Administration Modification for Infusion Reactions
Acute infusion reactions such as chills, fatigue, fever, nausea, and joint ache were frequently observed in studies of PROVENGE. To mitigate such reactions, premedication, consisting of acetaminophen and an antihistamine such as diphenhydramine, was administered in clinical studies prior to infusion.
In the event of an acute infusion reaction, the infusion may be interrupted or slowed, depending on the severity of the reaction. Appropriate medical therapy should be administered as needed. In controlled clinical trials, symptoms of acute infusion reactions were treated with acetaminophen, intravenous H1 and/or H2 blockers, and low dose intravenous meperidine.
If the infusion of PROVENGE must be interrupted, the infusion should not be resumed if the PROVENGE infusion bag will be held at room temperature for more than 3 hours. [See How Supplied/Storage and Handling (16).]