Gliadel Wafer

/ Megapharm

Each 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.

For use as an adjunct to surgery to prolong survival in patients with recurrent glioblastoma multiforme for whom surgical resection is indicated.
Gliadel implant is indicated in newly-diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation.
Gliadel implant is indicated for use as an adjunct to surgery in patients with Recurrent histogically proved glioblastoma multiforme for whom surgical resection is indicated.

GLIADEL Wafer contains carmustine. GLIADEL Wafer should not be given to
individuals who have demonstrated a previous hypersensitivity to carmustine or any of the components of GLIADEL Wafer.

See prescribing information for full details.

See prescribing information for full details.

Interactions with other drugs have not been formally evaluated.

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.
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.
Nursing Mothers: It is not known if either carmustine, carboxyphenoxypropane, or sebacic acid is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from carmustine in nursing infants, it is recommended that patients receiving GLIADEL Wafer discontinue nursing.

There is no clinical experience with use of more than eight GLIADEL Wafers per surgical procedure.

Storage: GLIADEL Wafer must be stored at or below -20ºC (-4ºF).