IMPORTANT SAFETY INFORMATION
GLIADEL Wafer can cause fetal harm when administered to a pregnant woman. It is recommended that patients receiving GLIADEL Wafer discontinue nursing. Female patients of reproductive potential should receive counseling on pregnancy planning and prevention. Advise male patients of the potential risk of infertility, and to seek counseling on fertility and family planning options prior to implantation of GLIADEL Wafer.
WARNINGS AND PRECAUTIONS
Seizures: Fifty-four percent (54%) of patients treated with GLIADEL Wafers in the recurrent disease trial experienced new or worsened seizures within the first five post-operative days. The median time to onset of the first new or worsened post-operative seizure was 4 days. Optimize anti-seizure therapy prior to surgery. Monitor patients for seizures postoperatively.
Intracranial Hypertension: Brain edema occurred in 23% of patients treated with GLIADEL Wafers in the initial surgery trial. Additionally, one GLIADEL-treated patient experienced intracerebral mass effect unresponsive to corticosteroids which led to brain herniation. Monitor patients closely for intracranial hypertension related to brain edema, inflammation, or necrosis of the brain tissue surrounding the resection. In refractory cases, consider re-operation and removal of GLIADEL Wafers or Wafer remnants.
Impaired Neurosurgical Wound Healing: Impaired neurosurgical wound healing including wound dehiscence, delayed wound healing, and subdural, subgleal, or wound effusions occur with GLIADEL Wafer treatment. In the initial disease trial, 16% of GLIADEL Wafer-treated patients experienced impaired intracranial wound healing and 5% had cerebrospinal fluid leaks. In the recurrent disease trial, 14% of GLIADEL Wafer-treated patients experienced wound healing abnormalities. Monitor patients post-operatively for impaired neurosurgical wound healing.
Meningitis: Meningitis occurred in 4% of patients receiving GLIADEL Wafers in the recurrent disease trial. Two cases of meningitis were bacterial; one patient required removal of the Wafers four days after implantation; the other developed meningitis following reoperation for recurrent tumor. One case was diagnosed as chemical meningitis and resolved following steroid treatment. In one case the cause was unspecified, but meningitis resolved following antibiotic treatment. Monitor postoperatively for signs of meningitis and central nervous system infection.
Wafer Migration: GLIADEL Wafer migration can occur. To reduce the risk of obstructive hydrocephalus due to wafer migration into the ventricular system, close any communication larger than the diameter of a Wafer between the surgical resection cavity and the ventricular system prior to Wafer implantation. Monitor patients for signs of obstructive hydrocephalus.
The most common adverse reactions in Newly-Diagnosed High Grade Malignant Glioma patients (incidence >10% and between arm difference ≥4%) are cerebral edema, asthenia, nausea, vomiting, constipation, wound healing abnormalities and depression.
The most common adverse reactions in Recurrent Glioblastoma Multiforme patients (incidence >10% and between arm difference ≥4%) are urinary tract infection, wound healing abnormalities and fever.
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