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Provenge

Generic Name: sipuleucel-t (SI-pu-LOO-sel-TEE)
Brand Name: Provenge

Provenge is used for:

Treating a certain type of advanced prostate cancer. It may also be used for other conditions as determined by your doctor.

Provenge is an autologous blood cell and immune cell activator combination. It works by targeting certain cancer cells in your prostate and increasing the immune response directed at them, which stops the growth and reproduction of the prostate cancer.

Do NOT use Provenge if:

  • you are allergic to any ingredient in Provenge

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Provenge:

Some medical conditions may interact with Provenge. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have heart or lung problems
  • if you have a history of blood clots or stroke

Some MEDICINES MAY INTERACT with Provenge. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Chemotherapy medicines (eg, cisplatin) or immunosuppressive agents (eg, prednisone) because they may decrease Provenge's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Provenge may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Provenge:

Use Provenge as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Provenge. Talk to your pharmacist if you have questions about this information.
  • Provenge is given as an injection at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions.
  • Your doctor may prescribe other medicines, including acetaminophen and an antihistamine (eg, diphenhydramine) for you to take before you use Provenge. This will help to decrease the risk of infusion-related side effects. Be sure to take these medicines exactly as prescribed by your doctor. If you miss a dose of these medicines or you do not take them exactly as prescribed, tell your doctor or nurse before your treatment with Provenge.
  • If you miss a dose of Provenge, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Provenge.

Important safety information:

  • Provenge is made from your own immune cells. You will be required to undergo a collection procedure (leukapheresis) where immune cells (eg, white blood cells) are removed from your blood about 3 days before each scheduled infusion of Provenge. These cells will be combined with a protein to make them ready for your infusion. Each time you receive Provenge, you will need to undergo this procedure. Your doctor will give you a schedule for your cell collection and infusion appointments. Contact your doctor right away if you miss an appointment.
  • Provenge is meant to help your immune system work better. Medicines that decrease the function of the immune system, including chemotherapy medicines (eg, cisplatin) or immunosuppressive agents (eg, prednisone), may decrease the effects of Provenge. Tell your doctor if you are taking any of these medicines. Discuss any questions or concerns with your doctor.
  • Some patients have had serious side effects during the infusion. These may include chills, dizziness, or fainting, fast heartbeat, fever, nausea, severe headache, shortness of breath, wheezing, tiredness, or vomiting. Tell your doctor if you have any of these effects or any other bad effects during the infusion.
  • Blood clots have happened with Provenge. Tell your doctor if you have ever had a blood clot.
  • PREGNANCY and BREAST-FEEDING: It is not known if Provenge can cause harm to the fetus. It is not known if it is found in breast milk. Provenge is not approved for use in women.

Possible side effects of Provenge:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; constipation, diarrhea; fatigue; joint aches.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine or dark urine; burning, numbness, or tingling; chest pain, or pressure; confusion; coughing up blood; headache; irregular heartbeat; muscle aches, pain, weakness, or cramping; nausea or vomiting; one-sided weakness; redness or pain at the injection site; shortness of breath; slurred speech; swelling, warmth, numbness, change of color, or pain in a leg or arm; symptoms of infection (eg, fever, chills, sore throat, ear or sinus pain, cough, more sputum or change in the color of sputum, painful urination, mouth sores, a wound that will not heal, anal itching or pain); unusual tiredness or weakness; vision problems.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Provenge:

Provenge is handled and stored by a health care provider. You will not store it at home. Keep all medicines out of the reach of children and away from pets.

General information:

  • If you have any questions about Provenge, please talk with your doctor, pharmacist, or other health care provider.
  • Provenge is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Provenge or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Provenge. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Provenge. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Provenge.

Issue Date: June 3, 2015
Database Edition 15.2.1.003
Copyright © 2015 Clinical Drug Information, LLC

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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