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Important Safety Information

Indications:
GLIADEL^® Wafer is indicated in patients with newly diagnosed high-grade malignant glioma as an adjunct to surgery and radiation. GLIADEL is also indicated in patients with recurrent glioblastoma multiforme as an adjunct to surgery.

Contraindication:
GLIADEL^® Wafer should not be given to patients who have demonstrated a previous hypersensitivity to carmustine or any of the components of GLIADEL.

Warnings:
Patients undergoing craniotomy for malignant glioma and implantation of GLIADEL 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, including one case leading to brain herniation.

Precautions:
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.

Computed tomography and magnetic resonance imaging of the head may demonstrate enhancement in the brain tissue surrounding the resection cavity after implantation of GLIADEL. This enhancement may represent edema and inflammation caused by GLIADEL or tumor progression.

The short-term and long-term toxicity profiles of GLIADEL when given in conjunction with chemotherapy have not been fully explored.

Pregnancy and Nursing:
There are no studies assessing the reproductive toxicity of GLIADEL. Carmustine, the active component of GLIADEL, can cause fetal harm when administered to a pregnant woman.

It is recommended that patients receiving GLIADEL discontinue nursing.

Adverse Events:

Seizures:
In the initial surgery trial, the incidence of seizures was 33.3% in patients receiving GLIADEL and 37.5% in patients receiving placebo. Grand mal seizures occurred in 5% of GLIADEL-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 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 and placebo. In this study, 12/22 (54%) of patients treated with GLIADEL and 2/22 (9%) of placebo patients experienced the first new or worsened seizure within the first five 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 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 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 or its remnants.

Healing Abnormalities:
The following healing abnormalities have been reported in clinical trials of GLIADEL: 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-treated patients and in 11.7% of placebo recipients. Cerebrospinal fluid leaks occurred in 5% of GLIADEL 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 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 and 6% in patients receiving placebo. In the recurrent setting, the incidence of brain abscess or meningitis was 4% in patients treated with GLIADEL and 1% in patients receiving placebo.

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GLIADEL® Wafer is a registered trademark of MGI PHARMA, INC. © 2007 MGI PHARMA, INC., Bloomington, MN 55437 GL0061-B 12/07