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Temodar Injection Generic Name & Formulations
Legal Class
Rx
General Description
Temozolomide 100mg; per vial; lyophilized pwd for IV infusion after reconstitution; contains mannitol.
Pharmacological Class
Alkylating agent.
See Also
How Supplied
Caps 5mg, 20mg, 100mg, 140mg 180mg—5, 14; 250mg—5; Single-use vials—1
Manufacturer
Temodar Injection Indications
Indications
Newly diagnosed glioblastoma multiforme. Refractory anaplastic astrocytoma.
Temodar Injection Dosage and Administration
Adult
See full labeling for monitoring and dose adjustment guidelines. IV: Infuse over 90 mins. Oral caps: 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 for 5 consecutive days if tolerated; continue until disease progression, discontinue if minimum dose not tolerated.
Children
Not established.
Temodar Injection Contraindications
Contraindications
Hypersensitivity to dacarbazine.
Temodar Injection Boxed Warnings
Not Applicable
Temodar Injection Warnings/Precautions
Warnings/Precautions
Myelosuppression (higher risk in women or elderly, esp. in 1st cycle). Do not begin therapy unless hematology (ANC and platelets) is acceptable. Do CBC prior to treatment initiation and 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. Perform LFTs at baseline, midway through Cycle 1, prior to each subsequent cycle, and 2–4wks after last dose. Screen for HBV infection prior to initiation. Monitor for signs of hepatitis or HBV reactivation during and several months after treatment; discontinue if occurs. 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.
Temodar Injection Pharmacokinetics
See Literature
Temodar Injection Interactions
Interactions
Concomitant carbamazepine, phenytoin, sulfamethoxazole/trimethoprim may complicate myelosuppression assessment. May be potentiated by valproic acid.
Temodar Injection Adverse Reactions
Adverse Reactions
Alopecia, fatigue, nausea, vomiting, anorexia, constipation, headache, convulsions, rash, hemiparesis, diarrhea, asthenia, fever, dizziness, abnormal coordination, viral infection, amnesia, insomnia, edema; myelosuppression (may be dose-limiting; see full labeling), hepatotoxicity (may be fatal).
Temodar Injection Clinical Trials
See Literature
Temodar Injection Note
Not Applicable
Temodar Injection Patient Counseling
See Literature
