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:
The structural formula for carmustine is:
Sources
Gliadel Manufacturers
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Eisai Inc.
![Gliadel (Polifeprosan 20 With Carmustine Implant) Wafer [Eisai Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Gliadel | Eisai Inc.
Each GLIADEL® Wafer contains 7.7 mg of carmustine, resulting in a dose of 61.6 mg when eight wafers are implanted. It is recommended that eight wafers be placed in the resection cavity if the size and shape of it allows. Should the size and shape not accommodate eight wafers, the maximum number of wafers as allowed should be placed. Since there is no clinical experience, no more than eight wafers should be used per surgical procedure.
Handling and Disposal1-7: Wafers should only be handled by personnel wearing surgical gloves because exposure to carmustine can cause severe burning and hyperpigmentation of the skin. Use of double gloves is recommended and the outer gloves should be discarded into a biohazard waste container after use. A surgical instrument dedicated to the handling of the wafers should be used for wafer implantation. If repeat neurosurgical intervention is indicated, any wafer or wafer remnant should be handled as a potentially cytotoxic agent.
GLIADEL® Wafer should be handled with care. The aluminum foil laminate pouches containing GLIADEL® Wafer should be delivered to the operating room and remain unopened until ready to implant the wafers. The outside surface of the outer foil pouch is not sterile.
Instructions for Opening Pouch Containing GLIADEL® Wafer
Figure 1: To remove the sterile inner pouch from the outer pouch, locate the folded corner and slowly pull in an outward motion.
Figure 2: Do NOT pull in a downward motion rolling knuckles over the pouch. This may exert pressure on the wafer and cause it to break.
Figure 3: Remove the inner pouch by grabbing hold of the crimped edge and pulling upward.
Figure 4: To open the inner pouch, gently hold the crimped edge and cut in an arc-like fashion around the wafer.
Figure 5: To remove the GLIADEL® Wafer, gently grasp the wafer with the aid of forceps and place it onto a designated sterile field.
Once the tumor is resected, tumor pathology is confirmed, and hemostasis is obtained, up to eight GLIADEL® Wafers (polifeprosan 20 with carmustine implant) may be placed to cover as much of the resection cavity as possible. Slight overlapping of the wafers is acceptable. Wafers broken in half may be used, but wafers broken in more than two pieces should be discarded in a biohazard container. Oxidized regenerated cellulose (Surgicel®) may be placed over the wafers to secure them against the cavity surface. After placement of the wafers, the resection cavity should be irrigated and the dura closed in a water tight fashion.
Unopened foil pouches may be kept at ambient room temperature for a maximum of six hours at a time.
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Arbor Pharmaceuticals
Gliadel | Western Family Foods Inc
• do not take more than directed (see overdose warning)adults and children 12 years and over
• take 2 caplets every 4-6 hours • swallow whole – do not crush, chew or dissolve • do not take more than 10 caplets in 24 hourschildren under 12 years
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![Gliadel (Carmustine) Wafer [Arbor Pharmaceuticals]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3f137411-2ad9-43d7-bfb7-c94e62f5d9a1&name=9337bffa-6337-4f79-b9ac-ebb0a0de52a6-01.jpg)
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