Sipuleucel-T

What is sipuleucel-t used for?

Sipuleucel-T is a prescription medicine that is used to treat prostate cancer.

Sipuleucel-T 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.

 Mechanism of Action

PROVENGE is classified as an autologous cellular immunotherapy. While the precise mechanism of action is unknown, PROVENGE is designed to induce an immune response targeted against PAP, an antigen expressed in most prostate cancers. During ex vivo culture with PAP-GM-CSF, APCs take up and process the recombinant target antigen into small peptides that are then displayed on the APC surface.

Before taking sipuleucel-t, tell your doctor:

• If you are allergic to sipuleucel-T; 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 sipuleucel-T, 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 sipuleucel-T 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 sipuleucel-t?

• Tell all of your health care providers that you take sipuleucel-T. 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 sipuleucel-T. Tell your doctor if you have ever had a blood clot. Talk with your doctor.

How is sipuleucel-t best taken?

Use sipuleucel-T 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 sipuleucel-T to help avoid side effects.
• You will need to have a cell collection called leukapheresis about 3 days before you get sipuleucel-T.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of sipuleucel-t 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 sipuleucel-t?

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 sipuleucel-t?

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

Label

Package Label 2

• sipuleucel-T 250 mL Lot XXXXXX-X
• Store Refrigerated 2-8°C DO NOT FREEZE
• Expiration Date: DD-MMM-YYYY
• Expiration Time: XX:XX Time Zone:
• First Name MI:
• Last Name:
• Date of Birth: DD-MMM-YYYY
• NOT EVALUATED FOR INFECTIOUS SUBSTANCES