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PROVENGE Treatment Process

Each dose of PROVENGE is personalized by taking your own blood cells and reprogramming them to jumpstart your immune system. This section also talks about the importance of PSA levels and the role they play in the PROVENGE treatment process. Here’s a step-by-step overview of the process:


Step 1: Cell collection

To make each dose, blood will be drawn from your body and passed through a machine that collects a small portion of your immune cells, along with some platelets and a small number of red blood cells. The machine returns the rest of the cells and blood to your body.

 

Step 2: PROVENGE treatment

Your immune cells are then sent to an FDA-approved manufacturing facility to be made into a dose of PROVENGE specifically for you.

  • Each dose of PROVENGE is given about 3 days after your cell collection procedure, and your appointment will take about 2 hours
  • The PROVENGE infusion procedure will take place at a different location than your cell collection procedure, usually your physician’s office

PROVENGE Treatment Cycle for Advanced Prostate Cancer

After 6 appointments, your treatment with PROVENGE is complete.

As this sample schedule shows, your time commitment for PROVENGE is 6 appointments over about a month. After these appointments, no future treatments with PROVENGE are necessary.

Example Commitment Calendar of PROVENGE Treatment Schedule


The importance of keeping scheduled appointments

It’s important to keep all of your scheduled treatment appointments and arrive prepared. Your dose of PROVENGE is custom made for you and has a short shelf life. If you miss an infusion appointment, your personal dose of PROVENGE will expire and can no longer be used. As a result, you’d have to repeat the cell collection procedure so a new custom dose of PROVENGE could be manufactured.

We encourage you to use the calendar inside your Patient Comfort Kit to set reminders for yourself. You can also ask family members or friends to mark your procedure dates on their calendars too, to help ensure that you do not miss any appointments.


Important information about PROVENGE and PSA levels

The prostate-specific antigen (PSA) test is often used to monitor progression of prostate cancer and how effectively your treatment is controlling the disease. However in the PROVENGE clinical trial, the main goal was not to lower PSA levels—it was to extend life. So even if your PSA levels do not go down, PROVENGE may help you live longer.

Changes in PSA levels may not be indicative of how well your PROVENGE treatment is working. Be sure to talk to your doctor if you have any questions or concerns about your PSA levels.

Preparing for Treatment

Financial Support May Be Available

More than 90% of Medicare fee-for-service (FFS) patients receiving PROVENGE are expected to have minimal to no out-of-pocket costs.
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Find a PROVENGE Treatment Center

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.