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About GLIADEL® Wafer
GLIADEL® Wafers are small, dime-sized biodegradable polymer wafers
that are designed to deliver BCNU or carmustine directly into the surgical cavity
created when a brain tumor is resected. Immediately after a neurosurgeon operates
to remove the high-grade malignant glioma, up to eight wafers are implanted along
the walls and floor of the cavity that the tumor once occupied. Each wafer contains
a precise amount of carmustine that dissolves slowly, delivering carmustine to the
surrounding cells.
GLIADEL® Wafer therapy is used in conjunction with
surgery
and
adjuvant radiation
to treat certain kinds of
brain tumors
called high-grade malignant gliomas. Please see below for
important safety information.
Learn more about malignant gliomas (a specific type of brain tumor) and therapy
with GLIADEL in the
About Brain Tumors
section.
GLIADEL Clinical Trials6
A clinical study was conducted in 240 men and women undergoing surgery for a newly
diagnosed high-grade malignant (cancerous) glioma. Each patient was randomly assigned
to receive either surgery with implantation of GLIADEL followed by radiation therapy,
or surgery with implantation of placebo wafers (wafers without any carmustine) followed
by radiation therapy.
The results of this study showed that survival was prolonged in the patients who
received GLIADEL wafers compared to those who received the placebo wafers; median
survival (the time when half of the patients in the study were still alive) increased
to 13.8 months from 11.6 months. The hazard ratio for GLIADEL treatment was 0.73(95%
CI: 0.56-0.95).
GLIADEL side effect profile6
Side effects that have been reported in patients receiving GLIADEL include seizures,
brain edema (swelling), healing abnormalities and intracranial infections (e.g.,
brain abscess and meningitis). To see how GLIADEL works, view our
mechanism of action video.
References
Prescribing Information
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 GLIADELWafer, can cause fetal harm when administered
to a pregnant woman. It is recommended that patients receiving GLIADEL Wafer discontinue
nursing.
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 obstructivehydrocephalus. 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
GLIADEL Wafer:
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 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 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 14% in 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 GLIADEL Wafer patients and 1% in patients receiving placebo.
Please see full Prescribing Information.
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