"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
GLIADEL Wafer is an implant for intracranial use, containing carmustine, a nitrosourea alkylating agent, and polifeprosan, a biodegradable copolymer used to control the release of carmustine. It is a sterile, off-white to pale yellow wafer approximately 1.45 cm in diameter and 1 mm thick. Each wafer contains 7.7 mg of carmustine [1, 3-bis (2-chloroethyl)-1-nitrosourea, or BCNU] and 192.3 mg of a biodegradable polyanhydride copolymer. The copolymer, polifeprosan 20, consists of poly [bis (p-carboxyphenoxy)] propane and sebacic acid in a 20:80 molar ratio. Carmustine is homogeneously distributed in the copolymer matrix.
The structural formula for polifeprosan 20 is:
The structural formula for carmustine is:
What are the possible side effects of carmustine (BiCNU, Gliadel)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- new or worsening cough, fever, trouble breathing;
- feeling short of breath on exertion;
- chest discomfort, dry cough or hack;
- feeling weak or tired, loss of appetite, rapid weight loss;
- fever, chills, body aches, flu symptoms, sores in your mouth and throat;
- easy bruising, unusual bleeding (nose,...
What are the precautions when taking polifeprosan 20 with carmustine (Gliadel)?
Before receiving carmustine/polifeprosan 20, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history.
This medication is not recommended for use during pregnancy. Consult your doctor for more details. If you become pregnant or think you may be pregnant, tell your doctor immediately.
It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before...
Last reviewed on RxList: 9/4/2013
This monograph has been modified to include the generic and brand name in many instances.
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