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Questions and Answers
about Plenaxis (abarelix for injectable suspension)
- What is Plenaxis and how does it work?
- Is Plenaxis a cure for advanced prostate cancer?
- Why is the FDA restricting the marketing of
Plenaxis?
- How do I know if Plenaxis is effective?
- Who should not be given Plenaxis?
- Is Plenaxis the only treatment for prostate cancer?
- Are there any side effects with taking Plenaxis?
- How will FDA and Praecis ensure the safe use of Plenaxis?
- How will I know if my doctor has signed up to prescribe Plenaxis?
- How can I report a serious side effect with Plenaxis to FDA?
- What if I have other questions about Plenaxis? Where can I go for more information on prostate cancer?
1. What is Plenaxis and how does it work?
Plenaxis is a type of medicine called a gonadotropin-releasing hormone (GnRH) antagonist that treats advanced, symptomatic prostrate cancer in men. Plenaxis works by blocking the body's ability to produce testosterone, the hormone that enables most prostate cancers to grow in men.
Because of risks of serious allergic reactions, Plenaxis is only approved to treat advanced, symptomatic prostate cancer in men who cannot have or refuse other treatments for prostate cancer, such as other hormone treatments or surgery to remove the testicles.
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2. Is Plenaxis a cure for advanced prostate cancer?
Treatment with Plenaxis is not a cure. Plenaxis can relieve symptoms related to prostate cancer near or pressing on the spine, causing problems urinating or blockages of urine from the kidneys or bladder, or very bad bone pain even when taking narcotic pain medicines. However,
Plenaxis sometimes may stop working in some men. And, it has some very serious risks, including serious, and potentially life-threatening, allergic reactions. That is why Plenaxis is only available through a program run by the manufacturer, called the Plenaxis PLUS program (Plenaxis User Safety Program); to make sure it is used safely by doctors with the right skills to administer and monitor the drug.
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3. Why is the FDA restricting the marketing of Plenaxis?
Because Plenaxis can cause serious and life threatening allergic reactions that need emergency medical treatment right away, only doctors enrolled in the Plenaxis PLUS Program should prescribe this medication. The risk management plan is designed to maximize the benefit to risk ratio for the drug by limiting its use to patients with advanced, symptomatic prostate cancer who are not candidates or who have refused other available therapy.
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4. How do I know if Plenaxis is effective?
Since Plenaxis works by reducing testosterone in the blood, checking testosterone levels in the blood will determine if Plenaxis is working. Your doctor should check blood levels of testosterone about every 8 weeks because
Plenaxis may stop working in some patients.
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5. Who should not be given Plenaxis?
Plenaxis is only approved for men with advanced, symptomatic prostate cancer who cannot have other hormone treatment or who refuse surgery to remove their testicles, and who have very bad symptoms, such as blockage of urine output or pain or very bad bone pain even when taking narcotic pain medicines.
Women and children under the age of 18 years should not be given Plenaxis.
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6. Is Plenaxis the only treatment for prostate cancer?
No. When it is still in an early stage, prostate cancer can be treated with surgery or radiation. When it is advanced, patients with prostate cancer are often treated with other hormones or with surgery to remove the testicles.
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7. Are there any side effects with taking Plenaxis?
Plenaxis can cause serious and life threatening allergic reactions soon after getting an injection. Such a reaction requires emergency medical treatment right away. That is why after each Plenaxis injection it is necessary to wait in the doctor's office or health care facility for 30 minutes.
These serious reactions may include:
- low blood pressure and fainting (shock)
- swelling of your face, eyelids, tongue, or throat
- asthma, wheezing, or other breathing problems such as chest tightness or shortness of breath
Other more common side effects of Plenaxis treatment are:
- hot flashes
- breast enlargement or pain
- tiredness
- headache
- testicles get smaller
- pain
- increase in urination
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8. How will FDA and Praecis ensure the safe use of Plenaxis?
The FDA and Praecis Pharmaceuticals, the manufacturer of Plenaxis, have worked together to create a program to ensure the safe use of Plenaxis and to verify that Plenaxis safety information is shared with patients. Some elements of the Plenaxis PLUS program are:
- Physician Attestation of Qualifications and Acceptance of Responsibilities
Plenaxis is only available from doctors who have the qualifications and accept certain responsibilities to prescribe Plenaxis. This signed physician attestation confirms that the doctor is qualified to manage advanced prostate cancer, can treat allergic reactions, and has the medications and equipment to handle allergic reactions.
- The Patient Information leaflet
This is an information sheet that highlights important information about risks and side effects. This will be given by the doctor's office prior to treatment. The information allows patients to take a more active role in their treatment, especially when that drug treatment involves the possibility of serious side effects. It is very important to read and follow these instructions before using Plenaxis. Patients who agree to treatment with Plenaxis will be asked to sign the last page of this leaflet.
- Plenaxis is always given in your doctor's office or a medical facility.
Plenaxis is given as an injection. After each Plenaxis injection, patients must wait in the doctor's office for 30 minutes in case a serious and life-threatening allergic reaction occurs. This way emergency equipment and medications are available if such a reaction occurs. Plenaxis will also be available in certain hospitals which have physicians enrolled in the Plenaxis PLUS Program.
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9. How will I know if my doctor has signed up to prescribe Plenaxis?
You may check to see if your doctor is enrolled in the Plenaxis PLUS Program by contacting Praecis Pharmaceuticals directly at
1-866-753-6294.
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10. How can I report a serious side effect with Plenaxis to FDA?
FDA encourages anyone aware of a serious side effect, including consumers or patients, to make a MedWatch report.
You can report an adverse event in two ways:
- Visit www.fda.gov/medwatch and click on "Submit Report" in the blue sidebar
- Call 1-800-FDA-1088 (1-800-332-1088)
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11. What if I have other questions about Plenaxis? Where can I go for more information on prostate cancer?
If you have further questions regarding the program for the safe use of Plenaxis, please contact the FDA's Center for Drug's Division of Drug Information at: 888.INFO.FDA
(1-888-463-6332), or email us at:
druginfo@fda.hhs.gov.
For more information about prostate cancer, call the National Cancer Institute's Cancer Information Service, at 1-800-4-CANCER
(1-800-422-6237) or visit
www.nci.nih.gov.
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Date created: November 25, 2003 |
