Immunotherapy For Advanced Prostate Cancer

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PROVENGE is a personalized immunotherapy that activates the immune system to help fight advanced prostate cancer and has been proven to help certain men with metastatic castration-resistant prostate cancer (mCRPC) live longer.

Learn more about PROVENGE
Learn more about PROVENGE
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What is metastatic castration-resistant prostate cancer?

Metastatic castration-resistant prostate cancer (mCRPC) is a form of advanced prostate cancer. Prostate cancer typically starts in the prostate gland, a small walnut-shaped organ located below the bladder in men. In its early stages, prostate cancer is often localized, meaning it remains confined to the prostate gland. During this phase, treatment options such as surgery, radiation therapy, and hormone therapy (also known as androgen deprivation therapy or ADT) are commonly employed to eliminate or control the cancer cells. ADT works by suppressing the production of testosterone, a hormone that fuels the growth of prostate cancer cells.

When prostate cancer no longer responds to androgen deprivation therapy (also known as ADT or hormone therapy) and spreads to other parts of the body, it is known as mCRPC. This means that the cancer cells have become resistant to the effects of ADT and may spread to other parts of the body. The most common sites of metastasis for prostate cancer include the bones, lymph nodes, liver, and lungs. The development of mCRPC signifies a more aggressive form of prostate cancer that requires specialized treatment approaches.

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PROVENGE is personal

PROVENGE is the first FDA-approved personalized immunotherapy for treatment of advanced prostate cancer. It has been clinically proven to extend life for certain men with mCRPC.

As a personalized immunotherapy, PROVENGE works differently from other cancer treatments, such as chemotherapy or hormone therapy.

PROVENGE is personalized because it’s made from your own immune cells. It empowers your immune system’s ability to recognize and attack your prostate cancer cells, while also creating immune memory to recognize prostate cancer continuously.

Similar to a vaccine, PROVENGE works to train your immune system’s ability to target and attack prostate cancer cells immediately, with effects that last over time.

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PROVENGE Immunotherapy offers many benefits

Proven to extend life: PROVENGE helps certain men with mCRPC live longer.

Well established safety profile: The most common side effects are generally mild to moderate and well tolerated. Some men have experienced serious adverse events while taking PROVENGE.

Short treatment course: Treatment is typically completed in 6 appointments over the course of about a month.

Is PROVENGE right for you?

PROVENGE is personalized immunotherapy used to treat men with prostate cancer who:

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Are castrate resistant

Have disease progression on hormone therapy (ADT) and have testosterone levels that are less than 50 ng/dL

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Have been diagnosed with metastatic disease

Meaning the cancer has spread from the prostate to other areas of the body, such as bones, lymph nodes, or soft tissue

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Are not taking narcotics for pain

PROVENGE is not for men who have severe cancer-related bone pain and are on narcotic treatment

PROVENGE has no contraindications and does not preclude other treatments for prostate cancer.

INDICATION

PROVENGE® (sipuleucel-T) is a prescription medicine used to treat certain men with advanced prostate cancer. PROVENGE is an established cellular immunotherapy and is customized to each individual by using his own immune cells.

IMPORTANT SAFETY INFORMATION

Before receiving PROVENGE®, tell your doctor about any medical conditions, including heart or lung problems, or if you have had a stroke.

Tell your doctor about any medicines you take, including prescription and nonprescription drugs, vitamins, or dietary supplements.

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 is made from your own immune cells, which are collected during a process called leukapheresis. The cells are processed, returned, and then infused back into the patient through an IV (intravenous) infusion about 3 days later. This process is completed in 3 cycles, about 2 weeks apart. Each infusion takes approximately 1 hour and requires 30 minutes of post-infusion monitoring.

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

  • Have signs of a heart attack or lung problems, such as trouble breathing, chest pains, racing or irregular heartbeats, high or low blood pressure, dizziness, fainting, nausea, or vomiting
  • Have signs of a stroke, such as numbness or weakness on one side of the body, decreased vision in one eye, or difficulty speaking
  • 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, shortness of breath, chest pain that worsens or deep breathing
  • Have signs of infection such as a fever over 100°F, redness or pain at the infusion or collection sites

Tell your doctor about any side effect(s) 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.

Full Prescribing Information.

To report an adverse event, please email our Pharmacovigilance department at drugsafety@dendreon.com, or fax adverse event details to 833-464-0123. Please provide details pertaining to the adverse event and provide contact information so that our Pharmacovigilance team may contact you with any questions.

To report a product complaint, email our Quality department at CQAcomplaints@dendreon.com. Please provide details pertaining to the quality issue and provide contact information so that our Quality team may contact you with any questions.

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