Gliadel® Wafer (polifeprosan 20 with carmustine implant) is indicated in patients with newly diagnosed high-grade malignant
glioma as an adjunct to surgery and radiation. Gliadel® Wafer is also indicated in
patients with recurrent glioblastoma multiforme as an adjunct to surgery.
Important Safety Information
Gliadel® Wafer should not be given to patients who have demonstrated a previous hypersensitivity
to carmustine or any of the components of Gliadel® Wafer.
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 1 case leading to brain herniation.
Carmustine, the active component of Gliadel® Wafer, can cause fetal harm when administered
to a pregnant women. It is recommended that patients receiving Gliadel® Wafer discontinue
Communication between the surgical resection cavity and the ventricular system should
be avoided to prevent the wafers from migrating into the ventricular system and
causing obstructive hydrocephalus. If a communication larger than the diameter of
a wafer exists, it should be closed prior to wafer implantation.
CT and MRI of the head may demonstrate enhancement in the brain tissue surrounding
the resection cavity after implantation of Gliadel® Wafer. This enhancement may represent
edema and inflammation caused by Gliadel® Wafer or tumor progression.
The short-term and long-term toxicity profiles of Gliadel® Wafer when given in conjunction
with chemotherapy have not been fully explored.
The following 4 categories of adverse events are possibly related to treatment with
Seizures: In the initial surgery trial, the incidence of seizures
was 33.3% in patients receiving Gliadel® Wafer and 37.5% in patients receiving placebo.
Grand mal seizures occurred in 5% of Gliadel® Wafer-treated patients and 4.2% of
placebo-treated patients. The incidence of seizures within the first 5 days after
wafer implantation was 2.5% in the Gliadel® Wafer group and 4.2% in the placebo group.
In the surgery for recurrent disease trial, the incidence of post-operative seizures
was 19% in both patients receiving Gliadel® Wafer and placebo. In this study, 12/22
(54%) of patients treated with Gliadel® Wafer and 2/22 (9%) of placebo patients experienced
the first new or worsened seizure within the first 5 post-operative days.
The median time to onset of the first new or worsened post-operative seizure was
3.5 days in patients treated with Gliadel® Wafer and 61 days in placebo patients.
Brain Edema: In the initial surgery trial, brain edema was noted
in 22.5% of patients treated with Gliadel® Wafer and in 19.2% of patients treated
with placebo. Development of brain edema with mass effect (due to tumor recurrences,
intracranial infection, or necrosis) may necessitate re-operation and, in some cases,
removal of Gliadel® Wafer or its remnants.
Healing Abnormalities: The following healing abnormalities have
been reported in clinical trials of Gliadel® Wafer clinical trials: wound dehiscence,
delayed wound healing, subdural, subgaleal or wound effusions, and cerebrospinal
fluid leak. In the initial surgery trial, healing abnormalities occurred in 15.8%
of Gliadel® Wafer-treated patients and in 11.7% of placebo recipients. Cerebrospinal
fluid leaks occurred in 5% of Gliadel® Wafer recipients and 0.8% of those given placebo.
During surgery, a water-tight dural closure should be obtained to minimize the risk
of cerebrospinal fluid leak. In the surgery for recurrent disease trial, the incidence
of healing abnormalities was the 14% of Gliadel® Wafer treated patients and 5% in
patients receiving placebo wafers.
Intracranial Infection: In the initial surgery trial, the incidence
of brain abscess or meningitis was 5% in patients treated with Gliadel® Wafer and
6% in patients receiving placebo. In the recurrent setting, the incidence of brain
abscess or meningitis was 4% in patients treated with Gliadel® Wafer and 1% in patients
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For more information about Gliadel® Wafer please see full Prescribing Information.
Arbor Pharmaceuticals cannot guarantee payment of any claim. Coding, coverage, and reimbursement may vary significantly by payer, plan, patient, and setting of care. Actual coverage and reimbursement decisions are made by individual payers following the receipt of claims. For additional information, customers should consult with their payers for all relevant coding, reimbursement, and coverage requirements. It is the sole responsibility of the provider to select the proper code and ensure the accuracy of all claims used in seeking reimbursement. All services must be medically appropriate and properly supported in the patient medical record.
This information is intended for use by our healthcare professionals in the United States only. Arbor Pharmacueticals recognizes the Internet is a global communications medium; however, laws, regulatory requirements and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here is not appropriate for use outside the United States. This site contains information about products that may have different product labeling in different countries.
Gliadel® is manufactured by Eisai Inc. for Arbor Pharmaceuticals, LLC.
Gliadel® is a registered trademark of Eisai Inc.
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