sipuleucel-T

What is the most important information I should know about sipuleucel-T?

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.

What is sipuleucel-T?

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.

What should I discuss with my healthcare provider before receiving sipuleucel-T?

Tell your doctor if you have ever had:

• heart problems;
• a stroke; or
• breathing problems.

How is sipuleucel-T given?

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.

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

What happens if I miss a dose?

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 while receiving sipuleucel-T?

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

What are the possible side effects of sipuleucel-T?

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.

• 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 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.

What other drugs will affect sipuleucel-T?

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.

Where can I get more information?

Your doctor or pharmacist can provide more information about sipuleucel-T.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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.

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