Carmustine wafer, polifeprosan 20 (Gliadel wafer)

General information

Class/mechanism: Biodegradable copolymer matrix (polifeprosan 20) embedded with carmustine, a nitrosourea which alkylates DNA and RNA and inhibits several key enzymatic processes by carbamoylation of amino acids in proteins. Each Gliadel wafer is 1.45 cm in diameter and 1 mm thick and contains 192.3 mg copolymer and 7.7 mg carmustine. Exposure to the surgical resection cavity results in hydrolyzation of anhydride bonds of the copolymer, which releases carmustine.
Route: implanted wafer
Extravasation: n/a

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias or the prescribing information.

Diseases for which it is used

• Glioblastoma
• High-grade glioma

Patient drug information

• Carmustine wafer, polifeprosan 20 (Gliadel) package insert
• Carmustine wafer, polifeprosan 20 (Gliadel) patient drug information (Chemocare)
• Carmustine wafer, polifeprosan 20 (Gliadel) patient drug information (UpToDate)

History of changes in FDA indication

• 1996-09-23: Initial FDA approval
• 2003-02-25 (oldest label available at Drugs @ FDA): indicated for newly diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation
• 2003-02-25 (oldest label available at Drugs @ FDA): indicated for recurrent glioblastoma multiforme patients as an adjunct to surgery

History of changes in EMA indication

• 1996-09-23: EURD

History of changes in PMDA indication

• 2012-09-28: Initial approval for the treatment of malignant glioma.

Also known as

• Code names: NPC-08, NSC-409962, WR-139021
• Generic name: polifeprosan 20 with carmustine implant
• Brand names: Biodel, Gliadel wafer