Drug Information


Gliadel Wafer

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.

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