Provenge

Generic name: sipuleucel-T

What is Provenge used for?

Provenge is used to treat prostate cancer.

Provenge may be given to you for other reasons. Talk to your doctor.

Description

PROVENGE (sipuleucel-T) is an autologous cellular immunotherapy available as a suspension for intravenous infusion. PROVENGE consists of autologous peripheral blood mononuclear cells, including antigen presenting cells (APCs), that have been activated during a defined culture period with a recombinant human protein, PAP-GM-CSF, consisting of prostatic acid phosphatase (PAP), an antigen expressed in prostate cancer tissue, linked to granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune cell activator. Each dose of PROVENGE contains a minimum of 50 million autologous CD54 + cells activated with PAP-GM-CSF, suspended in 250 mL of Lactated Ringer’s Injection, USP.

The active components of PROVENGE are autologous APCs and PAP-GM-CSF. During culture, the recombinant antigen can bind to and be processed by APCs into smaller protein fragments. The recombinant antigen is designed to target APCs, and may help direct the immune response to PAP. Minimal residual levels of the intact PAP-GM-CSF are detectable in the final PROVENGE product.

The patient’s peripheral blood mononuclear cells are obtained via a standard leukapheresis procedure approximately 3 days prior to the infusion date. Due to the autologous nature of PROVENGE, it is important that the patient and physician adhere to the personalized leukapheresis and infusion schedules.

The cellular composition of PROVENGE is dependent on the composition of cells obtained from the patient’s leukapheresis. In addition to APCs, the final product contains T cells, B cells, natural killer (NK) cells, and other cells. The number of cells present and the cellular composition of each PROVENGE dose will vary.

The potency of PROVENGE is in part determined by measuring the increased expression of the CD54 molecule, also known as ICAM-1, on the surface of APCs after culture with PAP-GM-CSF. CD54 is a cell surface molecule that plays a role in the immunologic interactions between APCs and T cells, and is considered a marker of immune cell activation.

In-process and final sterility tests are initiated prior to shipping, but the final results are not available for up to 7 days. PROVENGE is released for shipping based on acceptable results from 2-day incubation of the in-process sterility test.

Before taking Provenge, tell your doctor:

  • If you are allergic to Provenge; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If you are a woman. This medicine is not approved for use in women. If you are a woman using Provenge, talk with your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Provenge with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Provenge?

  • Tell all of your health care providers that you take Provenge. This includes your doctors, nurses, pharmacists, and dentists.
  • Some people have had side effects during or within 1 day after the infusion. Tell your doctor if you have any bad effects during or after the infusion.
  • Blood clots have happened with Provenge. Tell your doctor if you have ever had a blood clot. Talk with your doctor.

How is Provenge best taken?

Use Provenge as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as an infusion into a vein over a period of time.
  • Other drugs may be given before Provenge to help avoid side effects.
  • You will need to have a cell collection called leukapheresis about 3 days before you get Provenge.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

What are the side effects of Provenge that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
  • A burning, numbness, or tingling feeling that is not normal.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Shortness of breath.
  • Dizziness or passing out.
  • Chest pain or pressure or a fast heartbeat.
  • A heartbeat that does not feel normal.
  • Feeling very tired or weak.
  • Upset stomach or throwing up.
  • Headache.
  • Muscle pain.
  • Flu-like signs.
  • Swelling in the arms or legs.
  • Pain where the shot was given.
  • Redness or swelling where the shot is given.
  • Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.

What are some other side effects of Provenge?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Feeling tired or weak.
  • Back pain.
  • Constipation.
  • Diarrhea.
  • Joint pain.
  • Flushing.
  • Muscle spasm.
  • Not hungry.
  • Bone pain.
  • Signs of a common cold.
  • Not able to sleep.
  • Neck pain.
  • Weight loss.
  • Sweating a lot.
  • Shakiness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Provenge?

  • If you need to store Provenge at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

  • NDC 30237-8900-5
  • sipuleucel-T
  • PROVENGE ®
  • RX ONLY FOR AUTOLOGOUS USE ONLY
  • No U.S. standard of potency
  • CONTENTS: A minimum of 50 million autologous CD54 + cells activated with PAP-GM-CSF and suspended in Lactated Ringer’s Injection, USP.
  • Manufactured by:
  • Dendreon Pharmaceuticals LLC Seal Beach, CA 90740
  • Phone: 877-256-4545
  • U.S. Lic. # 1749
  • No preservatives. Gently mix and re-suspend the contents of the bag. 000074.01
  • One autologous dose for infusion. See package insert for full prescribing information and instructions for administration.
provenge
SRC: NLM .

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