Gliadel

Gliadel

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Questions & Answers

Side Effects & Adverse Reactions

Patients undergoing craniotomy for malignant glioma and implantation of GLIADEL® Wafer should be monitored closely for known complications of craniotomy, including seizures, intracranial infections, abnormal wound healing, and brain edema. Cases of intracerebral mass effect unresponsive to corticosteroids have been described in patients treated with GLIADEL® Wafer, including one case leading to brain herniation.

Pregnancy: There are no studies assessing the reproductive toxicity of GLIADEL® Wafer. Carmustine, the active component of GLIADEL® Wafer, can cause fetal harm when administered to a pregnant woman. Carmustine has been shown to be embryotoxic and teratogenic in rats at i.p. doses of 0.5, 1, 2, 4, or 8 mg/kg/day when given on gestation days 6 through 15. Carmustine caused fetal malformations (anophthalmia, micrognathia, omphalocele) at 1.0 mg/kg/day (about 1/6 the recommended human dose (eight wafers of 7.7 mg carmustine/wafer) on a mg/m2 basis). Carmustine was embryotoxic in rabbits at i.v. doses of 4.0 mg/kg/day (about 1.2 times the recommended human dose on a mg/m2 basis). Embryotoxicity was characterized by increased embryo-fetal deaths, reduced numbers of litters, and reduced litter sizes.

There are no studies of GLIADEL® Wafer in pregnant women. If GLIADEL® Wafer is used during pregnancy, or if the patient becomes pregnant after GLIADEL® Wafer implantation, the patient must be warned of the potential hazard to the fetus.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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.

History

There is currently no drug history available for this drug.

Other Information

GLIADEL® Wafer (polifeprosan 20 with carmustine implant) is a sterile, off-white to pale yellow wafer approximately 1.45 cm in diameter and 1 mm thick. Each wafer contains 192.3 mg of a biodegradable polyanhydride copolymer and 7.7 mg of carmustine [1,3-bis (2-chloroethyl)-1-nitrosourea, or BCNU]. Carmustine is a nitrosourea oncolytic agent. The copolymer, polifeprosan 20, consists of poly[bis(p-carboxyphenoxy) propane: sebacic acid] in a 20:80 molar ratio and is used to control the local delivery of carmustine. Carmustine is homogeneously distributed in the copolymer matrix.

The structural formula for polifeprosan 20 is:


gliadel-01

The structural formula for carmustine is:


gliadel-02

Gliadel Manufacturers


  • Eisai Inc.
    Gliadel (Polifeprosan 20 With Carmustine Implant) Wafer [Eisai Inc.]
  • Arbor Pharmaceuticals
    Gliadel (Carmustine) Wafer [Arbor Pharmaceuticals]

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