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Trade/other name(s): Provenge®

Why would this drug be used?

Sipuleucel-T is used to treat advanced prostate cancer that is no longer responding to hormone therapy.

How does this drug work?

Sipuleucel-T is a type of active cellular immunotherapy. It is also referred to as a cancer vaccine, although unlike most vaccines, it is used to treat, not prevent, cancer. This treatment is thought to work by helping the body's own immune system identify and attack prostate cancer cells.

Before taking this medicine

Tell your doctor…

  • If you are allergic to anything, including medicines, dyes, additives, or foods.
  • If you have any type of heart problems or lung problems. These problems could become worse when getting this treatment.
  • If you have ever had a stroke. This drug may increase your risk of stroke slightly.
  • If you have any other medical conditions such as liver disease, kidney disease, diabetes, arthritis, gout, or infections.
  • If you think you might want to have children in the future. It is not known if this drug affects fertility. Talk with your doctor about the possible risk with this drug.
  • About all prescription or over-the-counter medicines you are taking, including vitamins and herbs. In fact, keeping a written list of each of these medicines (including the doses of each and when you take them) with you in case of emergency may help prevent complications if you get sick.

Interactions with other drugs

Sipuleucel-T works by stimulating the body's immune system. Some medicines can weaken the immune system, which might make sipuleucel-T less effective. These include:

  • Most chemotherapy drugs
  • Oral corticosteroids (such as prednisone, triamcinolone, hydrocortisone, etc.)
  • Drugs given to people who have had organ transplants

Other drugs may also affect the immune system. Be sure your doctor is aware of all medicines and supplements you are taking.

Check with your doctor, nurse, or pharmacist about other medicines, vitamins, herbs, and supplements, and whether alcohol can cause problems with this medicine.

Interactions with foods

No serious interactions with food are known at this time. Check with your doctor, nurse, or pharmacist about whether foods may be a problem.

Tell all the doctors, dentists, nurses, and pharmacists you visit that you are taking this drug.

How is this drug taken or given?

Sipuleucel-T is given as a series of 3 infusions into a vein, with about 2 weeks between each infusion.

A few days before each treatment, some of your immune cells will be removed from your blood with a procedure called leukapheresis. Some people may need minor surgery to put a catheter (a thin, hollow tube) into a large vein beforehand. During leukapheresis, blood is removed from the body through the catheter and goes into a machine, which removes the immune cells. The rest of the blood is then returned to the body. This procedure usually takes a few hours and can have some side effects.

The immune cells are then sent to a lab, where they are exposed to a protein designed to produce an immune response against prostate cancer. The cells are then shipped back to the treatment center.

Each treatment is given a few days after leukapheresis as an infusion into a vein, similar to a blood transfusion, over about an hour. It is very important to keep your appointment for the infusion. If it is not given in time, the product may expire and you will need to get leukapheresis again to make another dose.

You may be given acetaminophen (Tylenol) and an antihistamine such as diphenhydramine (Benadryl) about 30 minutes before each treatment to lower the chances of an infusion reaction (see Precautions below). You will be watched at the treatment center for at least 30 minutes after the infusion to make sure you are not having a reaction to it.


This drug can cause infusion reactions in some people when it is given or within the next couple of days. Mild reactions usually consist of fever, chills, and feeling tired. More serious reactions happen rarely, but can be dangerous. Symptoms can include feeling lightheaded or dizzy, fever or chills, fatigue, nausea, vomiting, headache, shortness of breath, tightness in the throat, rapid heart rate, and muscle aches. Tell your doctor or nurse right away if you notice any of these symptoms during or after being given the drug.

This drug may raise the risk of stroke slightly. Tell your doctor if you have ever had a stroke or had problems with blood vessels in your brain. Tell your doctor or nurse right away if you notice a sudden headache, lightheadedness, vision changes, or trouble speaking or moving.

If you have a catheter put in your vein for leukapheresis, it is very important that you know how to care for it to help prevent infections. Be sure to let your doctor or nurse know right away if you have any signs of infection, such as fever (100.5oF or higher), chills, or swelling or redness around the catheter site.

Possible side effects

If you have any of the following side effects, talk to your doctor or nurse. They can help you understand these side effects and help you deal with them.


  • chills*
  • fatigue*
  • fever*
  • back pain
  • nausea*

Less common

  • headache*
  • vomiting*
  • low red blood cell counts (anemia)
  • feeling dizzy*
  • muscle aches*
  • feeling weak
  • shortness of breath*
  • blood in urine
  • high blood pressure
  • rash
  • sweating
  • numbness or tingling in the hands and feet (during leukapheresis)
  • tingling in the area around the mouth (during leukapheresis)
  • muscle spasms (during leukapheresis)


  • stroke*

*See the "Precautions" section for more detailed information.

Side effects not listed above can also occur in some patients. Tell your doctor or nurse if you develop these or any other problems.

FDA approval

Yes – first approved in 2010.

Disclaimer: This information does not cover all possible uses, actions, precautions, side effects, or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for talking with your doctor, who is familiar with your medical needs.

Last Medical Review: 05/04/2010
Last Revised: 05/04/2010