Provenge contains a protein that stimulates the body's immune system to help it respond against certain cancer cells.

Provenge is an immunotherapy medicine 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 success.

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. Sipuleucel-T is mixed with certain immune cells drawn from your own blood, and this mixture is injected into your body.

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 this 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 taking this medicine

To make sure Provenge is safe for you, tell your doctor if you have ever had:

• heart problems;

• a stroke; or

• breathing problems.

Provenge is given after a procedure called leukapheresis (LOO-kuh-fuh-REE-sis).

During leukapheresis, some of your blood is collected through a small tube (catheter) placed into a vein. The catheter is connected to a machine that separates your white blood cells from other parts of the blood.

The collected blood cells are then mixed with Provenge and injected back into your body about 3 days after leukapheresis.

When injected into your body, these treated blood cells help strengthen your immune system to target and attack certain prostate cancer cells.

A healthcare provider will give you this infusion, which takes about 60 minutes to complete. You will be watched closely for at least 30 minutes to make sure you do not have an infusion reaction.

You may be given other medications to help prevent serious side effects or an allergic reaction. Keep using these medicines for as long as your doctor has prescribed.

This treatment is usually given 3 times about 2 weeks apart.

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.

Usual Adult Dose for Prostate Cancer:

3 complete doses given at approximately 2-week intervals; infuse drug intravenously over 60 minutes.

Comments:
-Peripheral blood mononuclear cells from patients are obtained via the leukapheresis procedure, which should be performed approximately 3 days prior to each infusion.
-Patients should be pre-medicated orally with acetaminophen and an antihistamine (such as diphenhydramine) approximately 30 minutes prior to administration to minimize potential acute infusion reactions.
-The patient should be observed for acute infusion reactions for at least 30 minutes following each infusion.
-The maximum dosing interval has not been established.
-This drug is intended solely for autologous use.
-This drug is for IV use only; a cell filter should not be used.

Use: Treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

To make sure Provenge is safe for you, tell your doctor if you have ever had:

• heart problems;

• a stroke; or

• breathing problems.

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

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

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

Get emergency medical help if you have signs of an allergic reaction to Provenge: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection or within the first 24 hours afterward. Tell your caregiver if you feel tired, dizzy, nauseated, light-headed, feverish, chilled, or have fast heartbeats, trouble breathing, a severe headache, or pounding in your neck or ears.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• racing or irregular heartbeats;

• signs of infection - fever, pain or redness where a needle was placed for blood cell collection or infusion;

• signs of a stroke - sudden numbness or weakness (especially on one side of the body), vision problems, slurred speech;

• signs of a blood clot deep in the body - pain, swelling, warmth, or discoloration in an arm or leg; or

• signs of a blood clot in the lung - chest pain that gets worse with deep breathing, shortness of breath.

Common Provenge side effects may include:

• fever, chills, tiredness;

• back pain;

• nausea;

• headache; or

• joint pain.

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.

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. Other drugs may interact with sipuleucel-T, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.