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Recent News and Articles on the Keywords: cancer + fda + prostate Related to the article below (Last Update: 8/7/2008)
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FDA Approves Advanced Prostate Cancer Drug
The US Food and Drug Administration has approved a new drug to treat men with advanced prostate cancer who cannot be treated with other therapies. Abarelix (marketed as Plenaxis by Praecis Pharmaceuticals) will be available only through certain physicians, because of the risk of serious side effects.
The drug is a hormone therapy intended for men whose cancer is causing problems like urinary difficulties, bone pain, or pressure on the spinal cord. The patients must also be unable to take other hormone therapies, and unable or unwilling to have surgical castration (removal of the testicles).
About 5% to 10% of men with prostate cancer have the type of advanced disease that would make them eligible for treatment with abarelix.
The drug can cause serious -- and even life-threatening -- allergic reactions in some patients, including low blood pressure and fainting, swelling of the face, throat or tongue, and breathing difficulties. For this reason, only doctors who are participating in the manufacturer's risk management program will be able to prescribe and administer the drug.
Abarelix is given as an injection into the buttocks every two weeks for the first month, then every four weeks after that. Men who receive the drug must remain in the doctor's office for at least 30 minutes after the shot, to be sure no allergic reaction occurs.
Other possible side effects include hot flashes, problems sleeping, pain, breast enlargement or breast pain, and constipation. The drug can also cause changes in the liver, so liver function must be monitored regularly.
Abarelix is a new type of drug known as a luteinizing hormone-releasing hormone (LHRH) antagonist. It works by lowering levels of testosterone, a male hormone that can cause prostate cancer to grow. Men who take the drug need to have their testosterone levels checked every two months or so, to be sure the medication is still working.