Cancer Treatment Results  Survival Rates Cancer Treatments / Therapy Results
Cancer
 
Drug Details

Click here to go back to your search results.

Brand Name: Gliadel Wafer Trade Name: carmustine with Polifeprosan 20 Implant
FDA Approved For: GLIADEL® Wafer is indicated in newly-diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation. GLIADEL®Wafer is indicated in recurrent glioblastoma multiforme patients as an adjunct to surgery. Pediatric Use: The safety and effectiveness of GLIADEL®Wafer in pediatric patients have not been established.
Carcinogen: No carcinogenicity, mutagenicity or impairment of fertility
studies have been conducted with GLIADEL® Wafer. Carcinogenicity, mutagenicity and impairment of fertility studies
have been conducted with carmustine, the active component of GLIADEL®Wafer. Carmustine was given three times a
week for six months, followed by 12 months observation, to Swiss mice at i.p. doses of 2.5 and 5.0 mg/kg (about 1/5 and
1/3 the recommended human dose (eight wafers of 7.7 mg carmustine/wafer) on a mg/m2 basis) and to SD rats at i.p.
dose of 1.5 mg/kg (about 1/4 the recommended human dose on a mg/m2 basis). There were increases in tumor incidence
in all treated animals, predominantly subcutaneous and lung neoplasms.
Mutagen: Carmustine was mutagenic in
vitro (Ames assay, human lymphoblast HGPRT assay) and clastogenic both in vitro (V79 hamster cell micronucleus
assay) and in vivo (SCE assay in rodent brain tumors, mouse bone marrow micronucleus assay). Impairment of Fertility:
Carmustine caused testicular degeneration at i.p. doses of 8 mg/kg/week for eight weeks (about 1.3 times the recommended
human dose on a mg/m2 basis) in male rats.
Manufacturer and/or Distributor: Guilford Pharmaceuticals Inc.    

Adverse Reactions:
For a complete list of adverse reactions please click on the link "More Information" for this drug.


E-mail to a Friend More Information

 

Disclaimer:This site provides excerpts from the product label or professional information brochures for some drugs or information provided by the World Health Organization’s International Agency for Research on Cancer. The full information from these sources is not provided by CancerMonthly. To view the full label or professional information brochure please contact the FDA. A link to the product label or professional information brochure is provided for your convenience, but CancerMonthly is not responsible for the availability of such external sites or resources. In addition, CancerMonthly does not provide medical or any other health care advice, diagnosis or treatment. The site and its services, including the information above, are for informational purposes only and are not a substitute for professional medical advice, examination, diagnosis or treatment. Always seek the advice of your physician or other qualified health professional before starting any new treatment or making any changes to existing treatment. Do not delay seeking and do not disregard medical advice based on information on this site. Cancer Monthly is solely to be used as an informational resource and should never be used to replace contact with your licensed healthcare provider.