PROVENGE® (sipuleucel-T) is a prescription medicine used to treat certain men with advanced prostate cancer. PROVENGE is an established cellular immunotherapy and is customized to each individual by using his own immune cells.
IMPORTANT SAFETY INFORMATION
Before receiving PROVENGE®, tell your doctor about any medical conditions, including heart or lung problems, or if you have had a stroke.
Tell your doctor about any medicines you take, including prescription and nonprescription drugs, vitamins, or dietary supplements.
The most common side effects of PROVENGE include chills, fatigue, fever, back pain, nausea, joint ache, and headache. These are not all the possible side effects of PROVENGE treatment.
PROVENGE is made from your own immune cells, which are collected during a process called leukapheresis. The cells are processed, returned, and then infused back into the patient through an IV (intravenous) infusion about 3 days later. This process is completed in 3 cycles, about 2 weeks apart. Each infusion takes approximately 1 hour and requires 30 minutes of post-infusion monitoring.
PROVENGE infusion can cause serious reactions. Tell your doctor right away if you:
- Have signs of a heart attack or lung problems, such as trouble breathing, chest pains, racing or irregular heartbeats, high or low blood pressure, dizziness, fainting, nausea, or vomiting
- Have signs of a stroke, such as numbness or weakness on one side of the body, decreased vision in one eye, or difficulty speaking
- Develop symptoms of thrombosis which may include: pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, shortness of breath, chest pain that worsens or deep breathing
- Have signs of infection such as a fever over 100°F, redness or pain at the infusion or collection sites
Tell your doctor about any side effect(s) that concerns you or does not go away. For more information, talk with your doctor.
To report an adverse event, please email our Pharmacovigilance department at firstname.lastname@example.org, or fax adverse event details to 833-464-0123. Please provide details pertaining to the adverse event and provide contact information so that our Pharmacovigilance team may contact you with any questions.
To report a product complaint, email our Quality department at CQAcomplaints@dendreon.com. Please provide details pertaining to the quality issue and provide contact information so that our Quality team may contact you with any questions.