Newly Diagnosed Glioblastoma Multiforme: Temozolomide is indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.
Refractory Anaplastic Astrocytoma: Temozolomide is indicated for the treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.
Newly diagnosed glioblastoma multiforme: 75 mg/m<sup>2</sup> for 42 days concomitant with focal radiotherapy followed by initial maintenance dose of 150 mg/m<sup>2</sup> once daily for Days 1-5 of a 28-day cycle of Temozolomide for 6 cycles
Refractory Anaplastic Astrocytoma: Initial dose 150 mg/m<sup>2</sup> once daily for 5 consecutive days per 28-day treatment cycle.
The recommended dose for Temozolomide as an intravenous infusion over 90 minutes is the same as the dose for the oral capsule formulation. Bioequivalence has been established only when Temozolomide for Injection was given over 90 minutes
Pregnancy & Lactation
Pregnancy Category D. There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants and tumorigenicity shown for temozolomide in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of Temozolomide to the mother.