Temozar
Cheaper & Alternative Brands
Same generic (Temozolomide), same form (Capsule)
Clinical Prescribing Information
Medical monograph and safety information for healthcare professionals & patients.Indications & Clinical Uses
Newly Diagnosed Glioblastoma Multiforme
: Temonix is indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.
Refractory Anaplastic Astrocytoma
: Temonix is indicated for the treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.
Contraindications
Temozolomide is contraindicated in patients who have a history of hypersensitivity reaction to any of its components. Temozolomide is also contraindicated in patients who have a history of hypersensitivity to DTIC, since both drugs are metabolized to 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide MTIC).
Side Effects & Adverse Reactions
The most common adverse effects are: alopecia, fatigue, nausea, vomiting, headache, constipation, anorexia, convulsions, rash, hemiparesis, diarrhea, asthenia, fever, dizziness, coordination abnormal, viral infection, amnesia, and insomnia. The most common Grade 3 to 4 hematologic labcratory abnormalities that have developed during treatment with Temonix are: lymphopenia, thrombocytopenia, neutropenia, and leukopenia. Allergic reactions have also been reported.
Warnings & Precautions
Myelosuppression
: monitor Absolute Neutrophil Count (ANC) and platelet count prior to dosing and throughout treatment. Geriatric patients and women have a higher risk of developing myelosuppression. Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukemia, have been observed.
Pneumocystis carinii pneumonia (PCP)
: prophylaxis required for all patients receiving concomitant Temonix and radiotherapy for the 42-day regimen for the treatment of newly diagnosed glioblastoma multiforme. All patients, particularly those receiving steroids, should be observed closely for the development of lymphopenia and PCP. Complete blood counts should be obtained throughout the treatment course as specified. Fetal harm can occur when administered to a pregnant woman. Women should be advised to avoid becoming pregnant when receiving Temonix.
Pharmacology & Mechanism of Action
Temozolomide is not directly active but undergoes rapid nonenzymatic conversion at physiologic pH to the reactive compound Methyl Triazen Imidazole Carboxamide (MTIC). The cytotoxicity of MTIC is thought to be primarily due to alkylation of DNA. Alkylation (methylation) occurs mainly at the 0 6 and N 7 positions of guanine.