Frequently Asked Questions About Provenge® (Sipuleucel-T)
Class: Biological Therapy
Generic Name: Sipuleucel-T
Trade Name: Provenge®
How is Provenge used? Provenge is used for the treatment of prostate cancer that has few or no symptoms, but has spread to other parts of the body and does not respond to hormone therapy (metastatic, hormone-refractory prostate cancer).
What is the mechanism of action? Provenge mixes your own immune cells with a protein that prompts an immune response against cancer cells.
How is Provenge given (administered)? Provenge is given as an intravenous (IV) infusion. You will receive a total of three infusions about two weeks apart. Approximately three days before each infusion, a sample of your immune cells will be collected through a process known as leukapheresis; the cells are used to produce Provenge.
How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Provenge. Patients may undergo physical examinations, lab tests, or imaging to assess side effects and response to therapy.
What are the most common side effects of treatment with Provenge?
- Back pain
- Joint ache
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
- Pay careful attention to the physician’s instructions, and discuss side effects with your physician.
Are there any special precautions patients should be aware of before starting treatment?
- Patients should inform their physician about all medical conditions, including heart problems, lung problems, and history of stroke.
- Patients should inform their physician of any other medication or supplement they are taking (whether prescription or over-the-counter).
When should patients notify their physician?
Tell your doctor if you experience any side effects that bother you or don’t go away. Watch for signs of serious side effects and report these to your doctor immediately: breathing problems, chest pains, racing heart or irregular heartbeats, dizziness, nausea or vomiting, a fever over 100º F, or redness or pain at the infusion or collection sites.
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.
As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.
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The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.