"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"...
(carmustine for injection)
BiCNU (carmustine for injection) should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents.
Bone marrow suppression, notably thrombocytopenia and leukopenia, which may contribute to bleeding and overwhelming infections in an already compromised patient, is the most common and severe of the toxic effects of BiCNU (see WARNINGS and ADVERSE REACTIONS).
Since the major toxicity is delayed bone marrow suppression, blood counts should be monitored weekly for at least 6 weeks after a dose (see ADVERSE REACTIONS). At the recommended dosage, courses of BiCNU (carmustine) should not be given more frequently than every 6 weeks.
The bone marrow toxicity of BiCNU (carmustine) is cumulative and therefore dosage adjustment must be considered on the basis of nadir blood counts from prior dose (see "Dosage Adjustment Table" under DOSAGE AND ADMINISTRATION).
Pulmonary toxicity from BiCNU (carmustine) appears to be dose related. Patients receiving greater than 1400 mg/m2 cumulative dose are at significantly higher risk than those receiving less.
BiCNU® (carmustine for injection) is one of the nitrosoureas used in the treatment of certain neoplastic diseases. It is 1,3-bis (2-chloroethyl)-1-nitrosourea. It is sterile lyophilized pale yellow flakes or congealed mass with a molecular weight of 214.06. It is highly soluble in alcohol and lipids, and poorly soluble in water. BiCNU (carmustine) is administered by intravenous infusion after reconstitution as recommended.
The structural formula is:
BiCNU (carmustine) is available in 100 mg single dose vials of lyophilized material. Sterile diluent for constitution of BiCNU (carmustine) is co-packaged with the active drug product for use in constitution of the lyophile. The diluent is supplied in an ampule containing 3 mL of Dehydrated Alcohol Injection, USP.
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 carmustine (BiCNU)?
Before using carmustine, 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, especially of: blood/bone marrow disorders, liver disease, lung disease, kidney disease, recent/current infection.
Before having surgery, tell your doctor or dentist that you are using this medication.
Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.
Wash your hands well to...
Last reviewed on RxList: 5/5/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional BiCNU Information
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