PROVENGE

PROVENGE® (sipuleucel-T) Is FDA Approved

PROVENGE is an autologous cellular immunotherapy AUTOLOGOUS CELLULAR IMMUNOTHERAPYPROVENGE is classified by the FDA as an autologous cellular immunotherapy. It is designed to be an active cellular immunotherapy.Close for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

PROVENGE is made using cells from a patient's own immune system, so it cannot be warehoused like many other drugs and requires specialized manufacturing facilities.

How It Works

PROVENGE (PROH-venj) is designed to stimulate a patient’s immune system to target prostate cancer cells. The process of making PROVENGE involves the exposure of a patient’s immune cells to a protein that functions as a prostate cancer-associated antigen. An antigen is a substance that causes the body to react with an immune response. This process activates the patient’s immune cells against prostate cancer to help the immune system better fight the disease.

Patient Assistance & Reimbursement

Medicare and all major insurance plans have confirmed coverage for the
on-label use of PROVENGE and Dendreon is committed to helping every patient who is eligible for treatment with PROVENGE access it.

Dendreon provides a variety of support services to help facilitate treatment with PROVENGE. These services focus on patient assistance programs, supporting the reimbursement process. Through Dendreon’s Patient Assistance Program a dedicated case manager will:

  • Help with co-pays, co-insurance, and deductible costs by referring patients to independent foundations*
  • Assist uninsured patients and those who are uninsured due to payer claim denials†
  • Support patients with treatment-related travel costs by referring patients to independent foundations*
  • Provide reimbursement support, including help verifying benefits, assist with prior authorizations, and support claims appeals

*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.

†Services vary by office based on application criteria and are subject to change or discontinuation.

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

Indication and Important Safety Information

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

PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.

In controlled clinical trials, serious adverse events reported in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. Severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.

The most common adverse events (incidence ≥15%) reported in the PROVENGE group are chills, fatigue, fever, back pain, nausea, joint ache, and headache.

For more information on PROVENGE, please visit: www.PROVENGE.com.

Please see Full Prescribing Information or call Dendreon ON Call at 1-877-336-3736.