Provenge

Generic Name: sipuleucel-T (SI pu LOO sel tee)
Brand Names: Provenge

What is Provenge?

Provenge (sipuleucel-T) contains a protein that stimulates the body's immune system to help it respond against certain cancer cells.

Provenge is used to treat advanced prostate cancer in men.

Provenge is mixed with certain immune cells drawn from your own blood, and the mixture is later injected into your body. This type of treatment is called autologous immunotherapy.

Provenge is usually given after surgery or other medications have been tried without successful treatment.

Provenge may also be used for other purposes not listed in this medication guide.

Important information

Before you are treated with Provenge, tell your doctor about all of your medical conditions, especially heart disease, asthma, COPD or other breathing problems, or if you have ever had a stroke.

Provenge is used in a treatment called autologous immunotherapy. Provenge is mixed with certain immune cells drawn from your own blood, and this mixture is injected into your body.

Slideshow: Flashback: FDA Drug Approvals 2013

Your doctor will determine your schedule for cell collection and Provenge injection. Follow your doctor's instructions very carefully. The timing of cell collection in relation to Provenge infusion is extremely important. If you miss an infusion appointment your prepared infusion cannot be used in the future. Some people receiving a Provenge injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, tired, or nauseated, or if you have fever, chills, joint pain, severe headache, blurred vision, buzzing in your ears, anxiety, confusion, vomiting, chest pain, fast or uneven heartbeats, wheezing, chest tightness, or trouble breathing. These side effects may occur during the Provenge injection or within the first 24 hours after your infusion.

Before receiving Provenge

Before you are treated with Provenge, tell your doctor about all of your medical conditions.

If you have any of these conditions, you may need a Provenge dose adjustment or special tests:

  • heart disease;

  • asthma, chronic obstructive pulmonary disease (COPD), or other breathing problems; or

  • if you have ever had a stroke.

How is Provenge given?

Approximately 3 days before you receive Provenge, your immune cells will be collected with a procedure called leukapheresis.

During the leukapheresis procedure, your immune cells will be collected through a small tube (catheter) placed into a vein in each of your arms. If the veins in your arms cannot be used, the catheter will be placed into a vein in your neck or upper chest.

The cell-collection catheter is connected to a machine that draws out your blood and separates your immune cells from other parts of the blood.

The cell collection process can take up to 4 hours to complete.

The collected immune cells are then mixed with Provenge, which contains a special protein that helps activate your body's immune cells. When injected back into your, these activated immune cells may be able to "recognize" and attack certain prostate cancer cells.

Your prepared Provenge solution will be injected into a vein through an IV. You will receive this injection in a clinic or hospital setting approximately 3 days after your cell collection procedure. Provenge must be given slowly, and the IV infusion can take about 60 minutes to complete.

Your doctor will determine your schedule for cell collection and Provenge injection. Follow your doctor's instructions very carefully. The timing of cell collection in relation to Provenge infusion is extremely important. If you miss an infusion appointment your prepared infusion cannot be used in the future.

Provenge is usually given in 3 doses spaced 2 weeks apart. Follow your doctor's instructions.

You will be given oral medications before your IV infusion to help prevent certain side effects.

What happens if I miss a dose?

Call your doctor for instructions if you miss any appointment in your cell collection or Provenge infusion schedule.

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Provenge side effects

Some people receiving a Provenge injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, tired, or nauseated, or if you have fever, chills, joint pain, severe headache, blurred vision, buzzing in your ears, anxiety, confusion, vomiting, chest pain, fast or uneven heartbeats, wheezing, chest tightness, or trouble breathing. These side effects may occur during the Provenge injection or within the first 24 hours after your infusion.

Get emergency medical help if you have any of these signs of an allergic reaction to Provenge: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any other serious side effect, such as:

  • fever;

  • redness, swelling, oozing, or other signs of infection where the IV needle was placed; or

  • signs of infection around the veins your cells were collected from.

Less serious Provenge side effects may include:

  • back pain;

  • mild nausea;

  • headache; or

  • mild body aches.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Provenge?

Tell your doctor if you use any drugs that weaken your immune system, such as:

  • other cancer medicines;

  • steroids (prednisone and others); or

  • medicines to prevent rejection of a transplanted organ.

This list is not complete and other drugs may interact with Provenge. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about Provenge.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 1.01. Revision Date: 07/15/2010 2:06:26 PM.

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