Jane S. Ricciuti, RPh, MS


April 22, 2003

In This Article

Antineoplastic Agents

(Temozolomide) Capsules

Manufacturer: Schering Corporation

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 03/11/03)

Adverse Effects: Temodar (temozolomide) was studied in 2 open-label phase 2 studies in pediatric patients. The FDA has approved the addition of safety information to the Temodar labeling. The FDA has not approved Temodar for use in pediatric patients. Efficacy of Temodar in pediatric patients has not been established.

Temozolomide was studied in patients' aged 3-18 years at a dosage of 160-200 mg/m2 daily for 5 days every 28 days. The safety of temozolomide was assessed in a study involving 29 patients with recurrent brain stem glioma and 34 patients with recurrent high grade astrocytoma. The second study, by the Children's Oncology Group, enrolled 122 patients with medulloblastoma/PNET (29), high-grade astrocytoma (23), low-grade astrocytoma (22), brain stem glioma (16), ependymoma (14), other CNS tumors (9), and non-CNS. Pediatric adverse events from these phase 2 trials are listed in Table 2 .

Temodar (Temozolomide) Capsules Labeling

Temodar (Temozolomide) Capsules


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