Sipuleucel-T

Generic name: Sipuleucel-T
Brand names: Provenge
Dosage form: intravenous suspension (-)
Drug class: Therapeutic vaccines

Usage of 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.

Sipuleucel-T side effects

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.

Before taking Sipuleucel-T

Tell your doctor if you have ever had:

heart problems;

a stroke; or

breathing problems.

Relate drugs

How to use Sipuleucel-T

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.

Warnings

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 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.

Disclaimer

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