PROVENGE® (sipuleucel-T) is the first autologous cellular immunotherapy AUTOLOGOUS CELLULAR IMMUNOTHERAPYPROVENGE is classified by the FDA as an autologous cellular immunotherapy. It is designed to be an autologous cellular immunotherapy. Closeto receive FDA approval for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer. PROVENGE is designed to take the body’s own immune cells and reprogram them to attack advanced prostate cancer.

Important Safety Information

PROVENGE full Prescribing Information

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PROVENGE® (sipuleucel-T) is a prescription medicine that is used to treat certain patients with advanced prostate cancer. PROVENGE is made from your own immune cells.



  • Before getting PROVENGE, tell your doctor about all your medical problems, including problems with your heart or lungs, or if you have had a stroke

  • Tell your doctor about all the medicines you take, including prescription and nonprescription drugs, vitamins, and dietary supplements

  • PROVENGE is made from your own immune cells, collected approximately 3 days before each scheduled infusion of PROVENGE. The collection is called “leukapheresis” (pronounced loo-kuh-fuh-REE-sis). You will get PROVENGE in 3 intravenous infusions (put into your veins), about 2 weeks apart. Each infusion takes about 60 minutes. You will then be monitored for at least 30 minutes. Your doctor will give you a schedule for your cell collection and infusion appointments. It is very important that you arrive on time for your appointments

  • 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 infusion can cause serious reactions. Tell your doctor right away if you:

    • Have breathing problems, chest pains, racing heart or irregular heartbeats, high or low blood pressure, dizziness, fainting, nausea, or vomiting after getting PROVENGE. Any of these may be signs of heart or lung problems
    • Develop numbness or weakness on one side of the body, decreased vision in one eye, or difficulty speaking. Any of these may be signs of a stroke
    • 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, unexplained shortness of breath, chest pain that worsens on deep breathing
    • Get a fever over 100°F, or redness or pain at the infusion or collections sites. Any of these may be signs of infection

  • Tell your doctor about any side effect that concerns you or does not go away. For more information, talk with your doctor

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.

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