PROVENGE

PROVENGE® (sipuleucel-T) Is FDA Approved

PROVENGE is the first and only FDA approved immunotherapy IMMUNOTHERAPYTreatment that helps the immune system (the body’s natural defense) fight disease.Close for advanced prostate cancer.

PROVENGE is the only personalized treatment that is clinically proven to help extend life in certain men with advanced prostate cancer.

PROVENGE is an immunotherapy IMMUNOTHERAPYTreatment that helps the immune system (the body’s natural defense) fight disease.Closethat takes the patient’s own immune cells and reprograms them to attack his advanced prostate cancer. This process delivers a treatment designed just for each patient.

PROVENGE has proven results as an advanced prostate cancer immunotherapy
In the clinical trial, which was known as IMPACT, that supported FDA approval, more men treated with PROVENGE lived longer than men not treated with PROVENGE.

  • Median survival was 4.1 months longer for men who received PROVENGE (25.8 months) than for men who did not (21.7 months)*
    • PROVENGE reduced the risk of death by 22.5% for patients in the PROVENGE group*
  • More men in the PROVENGE group (nearly 38% more) were alive 3 years after the start of the study than men not treated with PROVENGE*
  • 1.5% of men discontinued treatment with PROVENGE due to side effects

*Individual results may vary.

How It Works

PROVENGE is an immunotherapy IMMUNOTHERAPYTreatment that helps the immune system (the body’s natural defense) fight disease. Close that is designed to reprogram the body’s immune cells to attack advanced prostate cancer cells. By jumpstarting immune cells already in the body, PROVENGE therapy helps take the fight against advanced prostate cancer into the patient’s own hands.

It is important to note that in the PROVENGE clinical trial, the main goal was not to lower PSA levels—it was to extend life. So even if PSA levels do not go down, PROVENGE may help certain men live longer.

PROVENGE Financial Coverage

75% of patients receiving PROVENGE are expected to have minimal to no out-of-pocket costs and PROVENGE is covered by Medicare as well as most other commercial plans.

There are many types of insurance, so be sure to speak with your doctor’s office. You can also get more information about your coverage, as well as whether you are eligible for additional financial support during treatment with PROVENGE, by calling 1-877-336-3736.

Our commitment to patients with limited financial resources

Dendreon wants to make sure help is available for patients who need financial assistance. Patient assistance programs include:

  • PROvide—A patient assistance program for patients with commercial insurance. PROvide supports eligible patients by covering any combination of cost—co-pays, co-insurance, or deductible costs—to a maximum of $6,000 over the 3 PROVENGE treatments*
  • Co-pay Assistance for Patients With Medicare—Help with co-pays, co-insurance, and deductible costs for eligible patients
  • Support for Patients Without Coverage for PROVENGE—Eligible patients may be able to get PROVENGE free of cost through the PROVENGE Uninsured Patient Program*
  • Travel Cost Assistance—Help with treatment-related travel costs for eligible patients

For more information, please call 1-877-336-3736.

*PROvide, the commercial copay card program, and the Uninsured Patient Program eligibility criteria can be changed or program can be discontinued at any time at the sole discretion of Dendreon, the maker of PROVENGE.

Co-pay and travel assistance foundations provide assistance regardless of the choice of medicine, and decisions are based on financial need and according to criteria established by individual foundations. Dendreon can assist patients by referring them to these independent organizations. Dendreon cannot guarantee that patients will be eligible for or receive assistance after referral. Dendreon does not have controlling or managerial influence on these independent organizations.

To learn more about PROVENGE, visit www.PROVENGE.com.

Indication

PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

Important Safety Information

Before getting PROVENGE, tell your doctor if you:

  • Have heart problems
  • Have lung problems
  • Have a history of stroke
  • Take any other medicines including prescription and nonprescription drugs, vitamins, and dietary supplements.

What are the possible side effects of PROVENGE?
PROVENGE infusion can cause serious reactions.

Tell your doctor right away if you:

  • Have breathing problems, chest pains, racing heart or irregular heartbeats, high or low blood pressure, dizziness, fainting, nausea, or vomiting after getting PROVENGE. Any of these may be signs of heart or lung problems.
  • Develop numbness or weakness on one side of the body, decreased vision in one eye or difficulty speaking. Any of these may be signs of a stroke.
  • Develop symptoms of thrombosis which may include pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath or chest pain that worsens on deep breathing.
  • Get a fever over 100˚F, or redness or pain at the infusion or collection sites. Any of these may be signs of infection.

The most common side effects of PROVENGE include chills, fatigue, fever, back pain, nausea, joint ache, and headache.

These are not all the possible side effects of PROVENGE treatment. For more information, talk with your doctor.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For more information on PROVENGE, please see the Full Prescribing Information or call 1-877-336-3736.

INDICATION

PROVENGE® (sipuleucel-T) is a prescription medicine that is used to treat certain patients with advanced prostate cancer. PROVENGE is made from your own immune cells.


IMPORTANT SAFETY INFORMATION

 

  • Before getting PROVENGE, tell your doctor about all your medical problems, including problems with your heart or lungs, or if you have had a stroke

  • Tell your doctor about all the medicines you take, including prescription and nonprescription drugs, vitamins, and dietary supplements

  • PROVENGE is made from your own immune cells, collected approximately 3 days before each scheduled infusion of PROVENGE. The collection is called “leukapheresis” (pronounced loo-kuh-fuh-REE-sis). You will get PROVENGE in 3 intravenous infusions (put into your veins), about 2 weeks apart. Each infusion takes about 60 minutes. You will then be monitored for at least 30 minutes. Your doctor will give you a schedule for your cell collection and infusion appointments. It is very important that you arrive on time for your appointments

  • The most common side effects of PROVENGE include chills, fatigue, fever, back pain, nausea, joint ache, and headache. These are not all the possible side effects of PROVENGE treatment

  • PROVENGE infusion can cause serious reactions. Tell your doctor right away if you:

    • Have breathing problems, chest pains, racing heart or irregular heartbeats, high or low blood pressure, dizziness, fainting, nausea, or vomiting after getting PROVENGE. Any of these may be signs of heart or lung problems
    • Develop numbness or weakness on one side of the body, decreased vision in one eye, or difficulty speaking. Any of these may be signs of a stroke
    • Develop symptoms of thrombosis which may include: pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain that worsens on deep breathing
    • Get a fever over 100°F, or redness or pain at the infusion or collections sites. Any of these may be signs of infection

  • Tell your doctor about any side effect that concerns you or does not go away. For more information, talk with your doctor

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.


Click here for full Prescribing Information.