Grading of Malignant Brain Tumors
A malignant brain tumor is usually rapidly growing, invasive, and life-threatening.
The World Health Organization assigns grades to brain tumors to aid communication,
to plan treatment and to predict outcome. The grade of a tumor reflects the degree
of malignancy. GLIADEL® Wafer is intended to treat malignant brain tumors that fall
into the grade III and grade IV categories.
A Grade III tumor is malignant and has a high tendency to recur at a
higher grade. The most severe tumors are grade IV tumors. They are able to form
new blood vessels to help maintain their growth, and they have areas of dead cells
in their centers. Glioblastoma multiforme is the most common type of a grade
IV brain tumor.
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.