Abarelix

Medical Briefing

Drug sale for some cancer patients OK'd

Compiled by Kawanza L. Griffin of the Journal Sentinel staff.

Monday, December 1, 2003

The Food and Drug Administration has approved the sale of Plenaxis (abarelix) for advanced prostate cancer patients who have no alternative therapy.

Because of the risk of low blood pressure and fainting as part of the allergic reaction to Plenaxis, only 5% to 10% of the patients will be able to take the drug, and those patients who receive the drug are to be monitored for at least 30 minutes after receiving a dose of the drug in their health care provider's office.

Plenaxis is a gonadotropin-releasing hormone antagonist that lowers the male hormone testosterone, a key factor involved in most prostate cancer growth. It is administered as an injection into the muscles of the buttocks every two weeks for the first month of therapy, followed by once every four weeks thereafter.

Because the drug may stop working in certain patients, doctors should perform blood tests about every two months to make sure Plenaxis is continuing to keep the level of testosterone low.

The most common side effects seen in the clinical trial were hot flashes, sleep disturbances, pain, including back pain, breast enlargement or pain, and constipation.

Manufacturer Praecis Pharmaceuticals Inc. will only distribute directly to physicians and hospital pharmacies enrolled in the Praecis' Plenaxis PLUS (Plenaxis User Safety) Program.

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