ACTIVE INGREDIENTS: Temozolomide 5 mg, 20 mg, 100 mg, 250mg.
Package(a):
CAPSULES: 5 x 5 mg. Dosage(a):
To be given in fasting state. In patients previously untreated with chemotherapy: 200 mg/m² once daily for 5 days per 28-day cycle. In patients previously treated with chemotherapy: Initial dose 150 mg/m² once daily, increased in the second cycle to 200 mg/m² daily, providing the absolute neutrophil count (ANC) is > 1.5 x 10(9)/1 and the thrombocyte count is > 100 x 10(9)/1 on day 1 of the next cycle. Children: 200 mg/m² once daily for 5 days per 28-day cycle. Patients previously treated with chemotherapy should receive an initial dose of 150 mg/m² once daily for 5 days with escalation to 200 mg/m² once daily at the next cycle if there is no haematological toxicity. Prescribing Restrictions: None
Package(b):
CAPSULES: 5 x 20 mg. Dosage(b):
To be given in fasting state. In patients previously untreated with chemotherapy: 200 mg/m² once daily for 5 days per 28-day cycle. In patients previously treated with chemotherapy: Initial dose 150 mg/m² once daily, increased in the second cycle to 200 mg/m² daily, providing the absolute neutrophil count (ANC) is > 1.5 x 10(9)/1 and the thrombocyte count is > 100 x 10(9)/1 on day 1 of the next cycle. Children: 200 mg/m² once daily for 5 days per 28-day cycle. Patients previously treated with chemotherapy should receive an initial dose of 150 mg/m² once daily for 5 days with escalation to 200 mg/m² once daily at the next cycle if there is no haematological toxicity. Prescribing Restrictions: None
Package(c):
CAPSULES: 5 x 100 mg. Dosage(c):
To be given in fasting state. In patients previously untreated with chemotherapy: 200 mg/m² once daily for 5 days per 28-day cycle. In patients previously treated with chemotherapy: Initial dose 150 mg/m² once daily, increased in the second cycle to 200 mg/m² daily, providing the absolute neutrophil count (ANC) is > 1.5 x 10(9)/1 and the thrombocyte count is > 100 x 10(9)/1 on day 1 of the next cycle. Children: 200 mg/m² once daily for 5 days per 28-day cycle. Patients previously treated with chemotherapy should receive an initial dose of 150 mg/m² once daily for 5 days with escalation to 200 mg/m² once daily at the next cycle if there is no haematological toxicity. Prescribing Restrictions: None
Package(d):
CAPSULES: 5 x 250 mg. Dosage(d):
To be given in fasting state. In patients previously untreated with chemotherapy: 200 mg/m² once daily for 5 days per 28-day cycle. In patients previously treated with chemotherapy: Initial dose 150 mg/m² once daily, increased in the second cycle to 200 mg/m² daily, providing the absolute neutrophil count (ANC) is > 1.5 x 10(9)/1 and the thrombocyte count is > 100 x 10(9)/1 on day 1 of the next cycle. Children: 200 mg/m² once daily for 5 days per 28-day cycle. Patients previously treated with chemotherapy should receive an initial dose of 150 mg/m² once daily for 5 days with escalation to 200 mg/m² once daily at the next cycle if there is no haematological toxicity. Prescribing Restrictions: None
Indications:
Malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy. Newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and subsequently as monotherapy treatment. Contra-Indications:
Hypersensitivity to its components or to dacarbazine (DTIC), severe myelosuppression, pregnancy and lactation. Special Precautions:
In patients with recurrent malignant glioma who are in a poor performance status or have other severely debilitating diseases or infection, administer after weighing the potential benefits and risks to the patient. Patients who have experienced severe (grade 3 or 4) vomiting in previous treatment cycles may require anti-emetic therapy. Elderly. Genotoxic effects. Side Effects:
Gastrointestinal disturbances. Fatigue, constipation, headache. Anorexia, diarrhoea, rash, fever and somnolence. Drug Interactions:
Valproic acid, other myelosuppressive agents.
