Temozolomide Accord is indicated for the treatment of:
– adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.
– children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Temozolomide Accord should only be prescribed by physicians experienced in the oncological treatment of brain tumours.
Anti-emetic therapy may be administered (see section 4.4).
Adult patients with newly-diagnosed glioblastoma multiforme
Temozolomide Accord is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
TMZ is administered orally at a dose of 75 mg/m2 daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions). No dose reductions are recommended, but delay or discontinuation of TMZ administration should be decided weekly according to haematological and non-haematological toxicity criteria. TMZ administration can be continued throughout the 42 day concomitant period (up to 49 days) if all of the following conditions are met:
– absolute neutrophil count (ANC) ≥ 1.5 x 109/l
– thrombocyte count ≥ 100 x 109/l
– common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea and vomiting).
Nausea, vomiting, loss of appetite, mouth sores, changes in taste, constipation, tiredness, dizziness, trouble sleeping, or headache may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects