TEMODAR Rx

Indications for TEMODAR:

Newly diagnosed glioblastoma multiforme. Refractory anaplastic astrocytoma.

Adult Dose for TEMODAR:

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.

Children's Dose for TEMODAR:

Not recommended.

Pharmacological Class:

Alkylating agent.

Contraindications:

Hypersensitivity to dacarbazine.

Warnings/Precautions:

Myelosuppression (higher risk in women or elderly, esp. in 1^st 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:

Valproic acid may increase temozolomide levels.

Adverse Reactions:

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