Adult Dosing
Newly diagnosed glioblastoma multiforme
- 75 mg/m2 IV x 42 days concomitant with focal XRT
- Maintenance dose: 150 mg/m2 IV qd x Days 1-5 of a 28-day cycle x 6 cycles
Refractory anaplastic astrocytoma
- Initial dose: 150 mg/m2 IV qd x 5 consecutive days per 28-day treatment cycle
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
Renal Dose Adjustment (Based on CrCl)
- <36 mL/min: Dose adjustments not defined, caution advised
Hepatic Dose Adjustment
- Severe hepatic impairment: Dose adjustments not defined, caution advised
- Monitor absolute neutrophil count (ANC) and platelet count prior to dosing and throughout treatment as therapy may cause myelosuppression, including prolonged pancytopenia, which may result in aplastic anemia. Geriatric patients and women have a higher risk of developing myelosuppression
- Myelodysplastic syndrome and secondary malignancies, including myeloid leukemia have been reported with the use of therapy
- Therapy may cause pneumocystis carinii pneumonia (PCP). Prophylaxis required for all patients receiving concomitant temozolomide and radiotherapy for the 42-day regimen for the treatment of newly diagnosed glioblastoma multiforme
- All patients, particularly those receiving steroids, should be observed carefully for the development of lymphopenia and PCP
- Obtain complete blood counts throughout the treatment course as specified
- Therapy has teratogenic effects. Fetal harm can occur when administered to a pregnant woman. Women should be advised to avoid becoming pregnant when receiving the therapy
Cautions: Use cautiously in
- Severe renal impairment
- Severe hepatic impairment
- Elderly patients
Pregnancy Category:D
Breastfeeding: Unsafe. Due to the potential for serious adverse reactions in nursing infants, manufacturer recommends discontinuation of nursing or discontinuation of drug, taking into account the importance of the drug to the mother.
