Monograph Details
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Neoplasms
> Alkylating agents
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TEMODAR |
| Manufacturer |
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Schering Corporation |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Alkylating agent. |
| Generic Name |
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Temozolomide 5mg, 20mg, 100mg, 140mg, 180mg, 250mg; caps. |
| Indications |
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Newly diagnosed glioblastoma multiforme. Refractory anaplastic astrocytoma. |
| Children |
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Not recommended. |
| Adults |
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See literature for monitoring and dose adjustment guidelines. Swallow whole with water; take on empty stomach at bedtime to reduce nausea, pretreat with antiemetics. Glioma: Concomitant phase, for newly diagnosed: 75mg/m2 daily for 42 days with focal radiotherapy; Maintenance phase, cycle 1: 150mg/m2 once daily for 5 consecutive days, then 23 days off; for cycles 2 through 6: increase to 200mg/m2 once daily for 5 consecutive days if tolerated, then 23 days off. Anaplastic astrocytoma: 150mg/m2 once daily for 5 consecutive days per 28-day treatment cycle; increase dose in subsequent cycles to 200mg/m2 if tolerated; continue until disease progression, discontinue if minimum dose not tolerated. |
| Contraindications |
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Hypersensitivity to dacarbazine. |
| Precautions |
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Myelosuppression (higher risk in women or elderly, esp. in 1st cycle). Do not begin therapy unless hematology (ANC and platelets) is acceptable. Do CBC on day 22 of each cycle or within 48 hours of that day; repeat weekly until recovery if ANC or platelets fall below acceptable limits. Glioblastoma: monitor for and provide prophylaxis against P. carinii pneumonia (PCP). Severe renal or hepatic impairment. Avoid inhalation, and skin/mucous membrane contact, of capsule contents. Elderly. Pregnancy (Cat.D), nursing mothers: not recommended. See literature. |
| Interactions |
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Valproic acid may increase temozolomide levels. |
| Adverse Reactions |
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Nausea, vomiting, anorexia, constipation, headache, other GI or CNS effects, alopecia, fatigue, convulsions, hemiparesis, fever, edema; myelosuppression (may be dose-limiting; see literature); others. |
| How Supplied |
Caps 5mg, 20mg, 100mg, 140mg 180mg—5, 14
250mg—5 |
| Additional Resources |
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• Related Prescribing Note |
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