About GLIADEL® Wafer
GLIADEL Wafer is a small, dime-sized wafer designed to deliver the chemotherapy
drug carmustine directly to the cavity created by the surgical removal of a malignant brain
tumor. Please see below for Important Safety Information about GLIADEL Wafer.
GLIADEL Wafer is approved by the U.S. Federal Food and Drug Administration
(FDA) to treat patients with a new diagnosis of high grade malignant glioma in addition
to surgery and radiation. GLIADEL Wafer is also intended to treat patients with
recurrent glioblastoma multiforme (GBM) in addition to surgery.
Learn more about malignant gliomas and therapy with GLIADEL Wafer at About Brain Tumors.
GLIADEL Wafer Clinical Trials
A clinical study was conducted in 240 men and women undergoing surgery for a newly
diagnosed high-grade malignant glioma. Each patient was randomly assigned to receive
either surgery with GLIADEL Wafer implants followed by radiation or surgery with
placebo wafer implants (wafers without carmustine) followed by radiotherapy.
Patients who received GLIADEL Wafer in combination with radiotherapy and surgery lived an average of 13.8 months, which was 2.2 months longer than patients who did
not receive GLIADEL Wafer.
A second clinical study was conducted in 222 men and women undergoing surgery for
a recurrent malignant glioma. Each patient was randomly assigned to receive either
surgery with GLIADEL Wafer implants or surgery with placebo wafer implants. In 145
patients with GBM who received GLIADEL Wafer in combination
with surgery lived an average of 6.4 months, which was 1.8 months longer than patients
who did not receive GLIADEL Wafer.
The results of these studies led to GLIADEL Wafer's FDA approvals.
GLIADEL Wafer Side Effects
Side effects that have been reported in patients receiving GLIADEL Wafer include
seizures, brain swelling, healing abnormalities and intracranial infections (e.g.
brain abscess and meningitis). Please see Important Safety Information below or
click here for full Prescribing
Information.
Indications
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
You should not be given GLIADEL Wafer if
you are allergic to carmustine or any of the
components of GLIADEL Wafer.
If you are undergoing surgery for malignant
glioma and implantation of GLIADEL Wafer,
you should be monitored closely for known
complications, including convulsions, infections,
abnormal wound healing, and swelling of
the brain.
If you are pregnant or are planning to become
pregnant, you should understand that
carmustine, the active component of GLIADEL
Wafer, can cause harm to the fetus if given to
a pregnant woman. It is not known if either
carmustine, or other components of GLIADEL
Wafer are excreted in human milk. Many drugs
are excreted in human milk and there is a risk
for serious side effects from carmustine in
nursing infants; therefore discontinuation of
nursing is recommended if you will be receiving
GLIADEL Wafer.
It is possible that if GLIADEL Wafers are
not implanted properly, they could block the
flow of cerebrospinal fluid and might cause
abnormal accumulation of fluid in the brain
(obstructive hydrocephalus).
The short-term and long-term safety of GLIADEL
Wafer when given together with chemotherapy
is not fully known.
Following surgery to remove a brain tumor and
implantation of GLIADEL Wafer, the following side
effects have been reported in clinical studies:
Seizures (convulsions): In clinical studies,
seizures have occurred within days or several
weeks following implantation of GLIADEL Wafer.
Both new seizures and worsening of seizures
have been reported.
Brain Swelling: Brain swelling has occurred in
clinical studies. In some cases, brain swelling
may require another surgery, and removal of
GLIADEL Wafers or remnants of the wafers may
be required.
Abnormal wound healing: In clinical studies,
abnormal healing of the surgical wound has
occurred following implantation of GLIADEL
Wafer. These abnormalities included reopening
of the surgical area, leaking of brain or spinal
fluid, delays in healing, or other abnormalities
in how the wound heals.
Brain Infections: In clinical studies, brain
infections, including meningitis, have occurred
following implantation of GLIADEL Wafer.
Please read the full Prescribing Information and discuss it with your doctor or healthcare professional. 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.