1. Newly-diagnosed high-grade glioma as an adjunct to surgery and radiation 2. Recurrent glioblastoma as an adjunct to surgery

Alkylating Agent / Nitrosourea Antineoplastic

Mean whole blood C_max 10.2 ± 4.8 ng/mL at ~3 hours post-insertion. Systemic absorption measurable for ~24 hours. >70% of copolymer degrades within 3 weeks.

None

Can cause fetal harm. Verify pregnancy status before use. Females: Use effective contraception for 6 months post-implantation. Males: Use effective contraception for 3 months post-implantation.

Advise not to breastfeed for at least 7 days after implantation.

Newly-diagnosed glioma (>10%): Cerebral edema (23%), asthenia (22%), nausea (22%), vomiting (21%), wound healing abnormalities (16%). Recurrent glioma (>10%): UTI (21%), wound healing abnormalities (14%), seizures (37%).

Eight wafers (61.6 mg total) implanted intracranially after maximal tumor resection. Place to cover resection cavity surface. Slight overlapping acceptable. Wafers broken in half may be used.

Safety and effectiveness not established in pediatric patients.

No dosage adjustments provided in manufacturer's labeling.

No dosage adjustments provided in manufacturer's labeling.

Store at or below -20°C. Unopened pouches: Maximum 6 hours at room temperature, up to 3 cycles within 30 days. Do not open until ready to implant. Cytotoxic drug requiring special handling.