Glossary

Apheresis: Withdrawal of blood from a person's body, removal of one or more components (such as plasma, platelets, or white blood cells), and transfusion of the remaining blood back into the person

Asymptomatic: Having no symptoms. For men being considered for treatment with PROVENGE, this means having no prostate cancer-related pain and not needing narcotics to lessen cancer-related pain

Autologous: Comes from you. PROVENGE is an autologous treatment because it is made from cells that come from your body

Blood center: A facility at which cell collection procedures take place

Castrate resistant (hormone refractory) cancer: Cancer that does not respond to hormone treatment or gets worse while being treated with hormone therapy

Cell Collection: Withdrawal of a small portion of certain types of blood cells from the body

Cellular: Made of cells. PROVENGE is a cellular treatment because it is made of the man’s own cells

Chemotherapy: Treatment that uses chemicals to treat diseases, such as cancer

Fatigue: A feeling of weariness and tiredness

Hormone therapy: Treatment that decreases the level of hormones in the body

Immunotherapy: Treatment that helps the immune system (the body’s natural defense) fight disease

Infusion: The act of putting fluid (usually medication) into a vein

Leukapheresis: A specific type of apheresis, in which white blood cells are removed from the withdrawn blood sample and after which the remaining blood is infused back into the person

Metastatic: Spread from the original location to other parts of the body; in prostate cancer, cancer that has spread from the prostate to places such as the bones

Minimally symptomatic: Having minor symptoms. For men being considered for treatment with PROVENGE, this means having relatively little prostate cancer-related pain and not needing narcotics to treat cancer related pain

Narcotics: Substances that relieve pain

Nausea: Feeling sick to the stomach, often associated with the urge to vomit

Prostate-specific antigen (PSA): A protein made by the prostate gland and by prostate cancer. A test for PSA is often used to screen for prostate cancer and to monitor some treatments for the disease

Sterility: Being free from living germs and other microscopic organisms

T cells: A type of immune cell that helps the immune system fight disease, such as viral infections and cancer

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INDICATION

PROVENGE® (sipuleucel-T) is a prescription medicine that is used to treat certain patients with advanced prostate cancer. PROVENGE is made from your own immune cells.

IMPORTANT SAFETY INFORMATION

  • Before getting PROVENGE, tell your doctor about all your medical problems, including problems with your heart or lungs, or if you have had a stroke
  • Tell your doctor about all the medicines you take, including prescription and nonprescription drugs, vitamins, and dietary supplements
  • PROVENGE is made from your own immune cells, collected approximately 3 days before each scheduled infusion of PROVENGE. The collection is called “leukapheresis” (pronounced loo-kuh-fuh-REE-sis). You will get PROVENGE in 3 intravenous infusions (put into your veins), about 2 weeks apart. Each infusion takes about 60 minutes. You will then be monitored for at least 30 minutes. Your doctor will give you a schedule for your cell collection and infusion appointments. It is very important that you arrive on time for your appointments
  • The most common side effects of PROVENGE include chills, fatigue, fever, back pain, nausea, joint ache, and headache. These are not all the possible side effects of PROVENGE treatment
  • PROVENGE infusion can cause serious reactions. Tell your doctor right away if you:
    • Have breathing problems, chest pains, racing heart or irregular heartbeats, high or low blood pressure, dizziness, fainting, nausea, or vomiting after getting PROVENGE. Any of these may be signs of heart or lung problems
    • Develop numbness or weakness on one side of the body, decreased vision in one eye, or difficulty speaking. Any of these may be signs of a stroke
    • Develop symptoms of thrombosis which may include: pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain that worsens on deep breathing
    • Get a fever over 100°F, or redness or pain at the infusion or collections sites. Any of these may be signs of infection
  • Tell your doctor about any side effect that concerns you or does not go away. For more information, talk with your doctor

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Click here for full Prescribing Information.