Provenge

Mechanism of Action

Autologous cellular immunotherapy; induces immune response targeted against PAP, an antigen expressed in most prostate cancers

Since this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.
 

Sipuleucel-T contains a protein that stimulates the body's immune system to help it respond against certain cancer cells.

Sipuleucel-T is used to treat advanced prostate cancer in men.

Sipuleucel-T is mixed with certain immune cells drawn from your own blood, and the mixture is later injected into your body. This type of treatment is called autologous (ah-TAL-oh-gus) immunotherapy.

Sipuleucel-T is usually given after surgery or other medications have been tried without successful treatment.

Sipuleucel-T may also be used for other purposes not listed in this medication guide.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Tell your doctor if you use any drugs that weaken your immune system, such as:

• other cancer medicines;

• steroids (prednisone and others); or

• medicines to prevent rejection of a transplanted organ.

This list is not complete and other drugs may interact with sipuleucel-T. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• 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.

This information should not be used to decide whether or not to take Provenge or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 Provenge. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Each Provenge infusion comprises the maximum number of cells that can be manufactured from a single leukapheresis procedure. The number of cells in Provenge does not exceed the number of cells collected from the leukapheresis. There are no known instances of overdosage from either a single infusion or a full course of therapy with Provenge.

Before you are treated with Provenge, tell your doctor about all of your medical conditions.

If you have any of these conditions, you may need a Provenge dose adjustment or special tests:

• heart disease;

• asthma, chronic obstructive pulmonary disease (COPD), or other breathing problems; or

• if you have ever had a stroke.

Approximately 3 days before you receive Provenge, your immune cells will be collected with a procedure called leukapheresis.

During the leukapheresis procedure, your immune cells will be collected through a small tube (catheter) placed into a vein in each of your arms. If the veins in your arms cannot be used, the catheter will be placed into a vein in your neck or upper chest.

The cell-collection catheter is connected to a machine that draws out your blood and separates your immune cells from other parts of the blood.

The cell collection process can take up to 4 hours to complete.

The collected immune cells are then mixed with Provenge, which contains a special protein that helps activate your body's immune cells. When injected back into your, these activated immune cells may be able to "recognize" and attack certain prostate cancer cells.

Your prepared Provenge solution will be injected into a vein through an IV. You will receive this injection in a clinic or hospital setting approximately 3 days after your cell collection procedure. Provenge must be given slowly, and the IV infusion can take about 60 minutes to complete.

Your doctor will determine your schedule for cell collection and Provenge injection. Follow your doctor's instructions very carefully. The timing of cell collection in relation to Provenge infusion is extremely important. If you miss an infusion appointment your prepared infusion cannot be used in the future.

Provenge is usually given in 3 doses spaced 2 weeks apart. Follow your doctor's instructions.

You will be given oral medications before your IV infusion to help prevent certain side effects.

Call your doctor for instructions if you miss any appointment in your cell collection or Provenge infusion schedule.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Tell your doctor if you use any drugs that weaken your immune system, such as:

• other cancer medicines;

• steroids (prednisone and others); or

• medicines to prevent rejection of a transplanted organ.

This list is not complete and other drugs may interact with Provenge. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Provenge can interact with other medications, herbs, or vitamins you might be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well. Your healthcare provider will look out for interactions with your current medications. Always be sure to tell your doctor about all medications, herbs, or vitamins you’re taking.

People with a history of heart problems

You’re at higher risk of serious infusion reactions from this drug. Before you start this drug, tell your doctor about your history of heart problems. They may monitor you more closely during treatment.

People with a history of stroke

This drug raises your risk of stroke. Your risk is even higher if you already have risk factors for stroke. Before you start this drug, tell your doctor about your history of stroke or any other risk factors. Your doctor may monitor you more closely during treatment.

People with lung problems

If you have lung problems or a history of lung problems, you’re at increased risk of serious infusion reactions from this drug. Before you start this drug, tell your doctor if you already have lung problems. They may monitor you more closely during treatment.

For children

This medication has not been studied in children. It should not be used in people younger than 18 years of age.

Allergies

This drug can cause a severe allergic reaction or infusion reaction. Symptoms can include:

• fever or chills
• tiredness
• nausea or vomiting
• joint aches

Your doctor will monitor you during the infusion. If you have a reaction, they may slow down or stop the infusion. You may be treated with other medications to treat the reaction.

Taking this drug again if you’ve ever had an allergic reaction to it could be fatal (cause death). Be sure to tell your doctor if you’ve ever had an allergic reaction to this drug.

Your doctor will determine a dosage of Provenge that’s right for you based on your individual needs. Your general health may affect your dosage. Tell your doctor about all health conditions you have before your healthcare provider administers the drug to you.

You’ll be given this drug in three infusions

How long does it take?

Can I drive home after?

Travel

Clinical monitoring

Insurance

Show Sources

• Provenge – sipuleucel-t injection. (2014, October 22). Retrieved from http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8309b497-5d4e-4408-ac0c-2452c11c8a35

Content developed in collaboration with University of Illinois-Chicago, Drug Information Group

Medically reviewed by Creighton University, Center for Drug Information and Evidence-Based Practice on February 12, 2016