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Provenge

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Provenge

PATIENT INFORMATION

PROVENGE®
(sipuleucel-T)

This leaflet is designed to help you understand treatment with PROVENGE (pronounced PROH-venj). The more you understand your treatment, the better you will be able to participate in your care. This leaflet does not take the place of talking with your doctor or healthcare professional about your medical condition or your treatment. If you have any questions, speak with your doctor.

What is PROVENGE?

PROVENGE is a prescription medicine that is used to treat certain patients with advanced prostate cancer. PROVENGE is made from your own immune cells.

What should I tell my doctor before getting PROVENGE?

Tell your doctor about all your medical problems, including:

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

How will I get PROVENGE?

Since PROVENGE is made from your own immune cells, your cells will be collected approximately 3 days before each scheduled infusion of PROVENGE. You will need to go to a cell collection center for this collection. The collection is called "leukapheresis" (pronounced loo-kuh-fuh-REE-sis). Your collected cells are sent to a special manufacturing center where they are mixed with a protein to make them ready for your infusion.

You will get PROVENGE in 3 intravenous infusions (put into your veins), about 2 weeks apart. Each infusion takes about 60 minutes. Following each infusion, you will 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. If you miss an appointment and cannot be infused, your PROVENGE dose will not be usable. Your doctor will work with you to schedule a new appointment at the cell collection center. You may also get a new infusion appointment.

What are the possible or reasonably likely side effects of PROVENGE?

The most common side effects of PROVENGE include:

  • chills
  • fatigue
  • fever
  • back pain
  • nausea
  • joint ache
  • headache

PROVENGE infusion can cause serious reactions. Tell your doctor right away if you have breathing problems, chest pains, racing heart or irregular heartbeats, dizziness, nausea, or vomiting after getting PROVENGE because any of these may be signs of heart or lung problems.

Tell your doctor right away if you get a fever over 100°F, or redness or pain at the infusion or collection sites, because any of these may be signs of infection.

Tell your doctor about any side effect that concerns you or does not go away.

These are not all the possible side effects of PROVENGE treatment. For more information, talk with your doctor.

What are the ingredients in PROVENGE?

The active components of PROVENGE are your own immune cells mixed with the other active component, a protein designed to produce an immune response to prostate cancer. The product is suspended in an infusion solution called Lactated Ringer's Injection, USP, an inactive ingredient.

Last reviewed on RxList: 7/18/2011
This monograph has been modified to include the generic and brand name in many instances.

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


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