Medication Guide App

Sipuleucel-t

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

Sipuleucel-t is used for:

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

Sipuleucel-t 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 sipuleucel-t if:

  • you are allergic to any ingredient in sipuleucel-t

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

Slideshow: Flashback: FDA Drug Approvals 2013

Before using sipuleucel-t:

Some medical conditions may interact with sipuleucel-t. 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 a history of heart or lung problems, or a stroke

Some MEDICINES MAY INTERACT with sipuleucel-t. 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 sipuleucel-t's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if sipuleucel-t 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 sipuleucel-t:

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

  • An extra patient leaflet is available with sipuleucel-t. Talk to your pharmacist if you have questions about this information.
  • Sipuleucel-t is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using sipuleucel-t at home, a health care provider will teach you how to use it. Be sure you understand how to use sipuleucel-t. Follow the procedures you are taught when you use a dose. 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 sipuleucel-t. 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 sipuleucel-t.
  • Sipuleucel-t should be slightly cloudy and a cream-to-pink color. Gently mix sipuleucel-t before using. Do not use sipuleucel-t if it contains particles or clumps after mixing, it is discolored, or if the container leaks or is cracked or damaged.
  • If you miss a dose of sipuleucel-t, contact your doctor right away.

Ask your health care provider any questions you may have about how to use sipuleucel-t.

Important safety information:

  • Sipuleucel-t may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use sipuleucel-t with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Sipuleucel-t 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 sipuleucel-t. These cells will be combined with a protein to make them ready for your infusion. Each time you receive sipuleucel-t, 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.
  • Sipuleucel-t 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 sipuleucel-t. Tell your doctor if you are taking any of these medicines. Discuss any questions or concerns with your doctor.
  • PREGNANCY and BREAST-FEEDING: It is not known if sipuleucel-t can cause harm to the fetus. It is not known if it is found in breast milk. Sipuleucel-t is not approved for use in women.

Possible side effects of sipuleucel-t:

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; fatigue; headache; joint aches; mild pain, fever, or chills; nausea; weakness.

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); burning, numbness, or tingling; chest pain; confusion; fatigue; fast or irregular heartbeat; fever, chills, or sore throat; muscle spasms or aches; one-sided weakness; redness or pain at the injection site; severe joint aches; severe muscle pain, weakness, or cramping; severe or persistent dizziness, headache, or nausea; shortness of breath; slurred speech; tremors; unusual tiredness or weakness; vision problems; vomiting.

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 sipuleucel-t:

Sipuleucel-t is usually handled and stored by a health care provider. If you are using sipuleucel-t at home, store sipuleucel-t as directed by your pharmacist or health care provider. Do not use sipuleucel-t if it is past its expiration date. Keep sipuleucel-t out of the reach of children and away from pets.

General information:

  • If you have any questions about sipuleucel-t, please talk with your doctor, pharmacist, or other health care provider.
  • Sipuleucel-t 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 sipuleucel-t 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 sipuleucel-t. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to sipuleucel-t. 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 sipuleucel-t.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

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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