el® Wafer and 6% in patients receiving placebo. In the recurrent setting, the incidence of brain abscess or meningitis was 4% in patients treated with Gliadel® Wafer and 1% in patients receiving placebo.
The following adverse events, not listed in the table above, were reported in less than 4% but at least 1% of patients treated with Gliadel® Wafer in all studies. The events listed were either not present pre-operatively or worsened post-operatively. Whether Gliadel® Wafer caused these events cannot be determined.
Body as a Whole: peripheral edema (2%); neck pain (2%); accidental injury (1%); back pain (1%); allergic reaction (1%); asthenia (1%); chest pain (1%); sepsis (1%)
Cardiovascular System: hypertension (3%); hypotension (1%)
Digestive System: diarrhea (2%); constipation (2%); dysphagia (1%); gastrointestinal hemorrhage (1%); fecal incontinence (1%)
Hemic and Lymphatic System: thrombocytopenia (1%); leukocytosis (1%)
Metabolic and Nutritional Disorders: hyponatremia (3%); hyperglycemia (3%); hypokalemia (1%)
Musculoskeletal System: infection (1%)
Nervous System: hydrocephalus (3%); depression (3%); abnormal thinking (2%); ataxia (2%); dizziness (2%); insomnia (2%); monoplegia (2%); coma (1%); amnesia (1%); diplopia (1%); paranoid reaction (1%). In addition, cerebral hemorrhage and cerebral infarct were each reported in less than 1% of patients treated with Gliadel® Wafer.
Respiratory System: infection (2%); aspiration pneumonia (1%)
Skin and Appendages: rash (2%)
Special Senses: visual field defect (2%); eye pain (1%)
Urogenital System: urinary incontinence (2%)
OVERDOSAGE
There is no clinical experience with use of more than eight Gliadel® Wafers per surgical procedure.
DOSAGE AND ADMINISTRATION
Each Gliadel® Wafer contains 7.7 mg of carmustine, resulting in a dose of 61.6 mg when eight wafers are implanted. It is recommended that eight wafers be placed in the resection cavity if the size and shape of it allows. Should the size and shape not accommodate eight wafers, the maximum number of wafers as allowed should be placed. Since there is no clinical experience, no more than eight wafers should be used per surgical procedure.
Handling and Disposal1-7: Wafers should only be handled by personnel wearing surgical gloves because exposure to carmustine can cause severe burning and hyperpigmentation of the skin. Use of double gloves is recommended and the outer gloves should be discarded into a biohazard waste container after use. A surgical instrument dedicated to the handling of the wafers should be used for wafer implantation. If repeat neurosurgical intervention is indicated, any wafer or wafer remnant should be handled as a potentially cytotoxic agent.
Gliadel® Wafer should be handled with care. The aluminum foil laminate pouches containing Gliadel® Wafer should be delivered to the operating room and remain unopened until ready to implant the wafers. The outside surface of the outer foil pouch is not sterile.
Instructions for Opening Pouch Containing Gliadel® Wafer
Figure 1: To remove the sterile inner pouch from the outer pouch, locate the folded corner and slowly pull in an outward motion.
Figure 2: Do NOT pull in a downward motion rolling knuckles over the pouch. This may exert pressure on the wafer and cause it to break.
Figure 3: Remove the inner pouch by grabbing hold of the crimped edge and pulling upward.
Figur
