Temodar Capsules(temozolomide)
General Information
Temodar (temozolomide) capsules have been approved for the treatment of adult patients with refractory anaplastic astrocytoma. Temodar is the first new chemotherapy agent for this type of brain tumor approved in the U.S. in 20 years.
The median survival time for patients with this disease ranges from two to three years from the time of initial diagnosis. Despite intensive treatment with surgery, radiotherapy, and chemotherapy, these patients almost invariably experience tumor recurrence, often within a year of completing first-line therapy. The annual incidence of anaplastic astrocytoma in the United States is one to 1.5 cases per 100,000 persons, with 2,000 to 3,000 new cases diagnosed per year.
Side Effects
In the clinical study, thrombocytopenia and neutropenia was the dose-limiting adverse event. The most common side effects were nausea, vomiting, headache, fatigue, and constipation.
Mechanism of Action
Temodar, an oral cytotoxic alkylating agent, is the lead agent in a new class of compounds known as imidazotetrazines. Cytotoxic agents are designed to prevent the replication of cells that divide rapidly, including those in tumors.
TEMODAR Rx
Generic Name and Formulations:
Temozolomide 5mg, 20mg, 100mg, 140mg, 180mg, 250mg; caps.
Company:
Merck & Co., Inc.
Indications for TEMODAR:
Newly diagnosed glioblastoma multiforme. Refractory anaplastic astrocytoma.
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.
Contraindications:
Hypersensitivity to dacarbazine.
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.
Interactions:
Concomitant carbamazepine, phenytoin, sulfamethoxazole/trimethoprim may complicate myelosuppression assessment. May be potentiated by valproic acid.
See Also:
TEMODAR INJECTION
Pharmacological Class:
Alkylating agent.
Adverse Reactions:
Alopecia |
