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.
uses
What is Provenge (Sipuleucel-T) used for?
- Prostate Cancer
warnings
What is the most important information I should know about Provenge (Sipuleucel-T)?
Tell your doctor if you have ever had:
- heart problems;
- a stroke; or
- breathing problems.
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Side Effects
What are the side effects of Provenge (Sipuleucel-T)?
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.
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 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.
Interactions
What drugs and food should I avoid while taking Provenge (Sipuleucel-T)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Dosage Guidelines & Tips
How to take Provenge (Sipuleucel-T)?
Use Provenge (Sipuleucel-T) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
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.
Call your doctor for instructions if you miss any appointment in your cell collection or sipuleucel-T infusion schedule.
Overdose Signs
What happens if I overdose on Provenge (Sipuleucel-T)?
Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
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