Sipuleucel-T is an immunotherapy medicine used to treat advanced prostate cancer in men.

Sipuleucel-T is made from a small amount of your own white blood cells, removed from blood that is drawn from your body.

Sipuleucel-T is usually given after surgery or other treatments have failed.

Sipuleucel-T may also be used for purposes not listed in this medication guide.

Before receiving sipuleucel-T tell your doctor about all your medical conditions or allergies, all medicines you use, and if you are pregnant or breastfeeding.

Sipuleucel-T 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 sipuleucel-T 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 sipuleucel-T injection. Follow your doctor's instructions very carefully. The timing of cell collection in relation to sipuleucel-T 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.

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 sipuleucel-T 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: 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.

Sipuleucel-T may cause serious side effects. 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 side effects of sipuleucel-T 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 affect sipuleucel-T, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.