Temodal 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg hard capsules

Each hard capsule contains 5 mg, 20 mg, 100 mg, 140, 180 mg or 250 mg temozolomide.

Excipient with known effect:

Each 5 mg hard capsule contains 132.8 mg of anhydrous lactose.

Each 20 mg hard capsule contains 182.2 mg of anhydrous lactose.

Each 100 mg hard capsule contains 175.7 mg of anhydrous lactose

Each 140 mg hard capsule contains 246 mg of anhydrous lactose.

Each 180 mg hard capsule contains 316.3 mg of anhydrous lactose.

Each 250 mg hard capsule contains 154.3 mg of anhydrous lactose.

For the full list of excipients, see section 6.1.

Hard capsule (capsule).

The 5 mg hard capsules have an opaque white body, an opaque green cap, and are imprinted with black ink. The cap is imprinted with “Temodal”. The body is imprinted with “5 mg”, the Schering-Plough logo and two stripes.

The 20 mg hard capsules have an opaque white body, an opaque yellow cap, and are imprinted with black ink. The cap is imprinted with “Temodal”. The body is imprinted with “20 mg”, the Schering-Plough logo and two stripes.

The 100 mg hard capsules have an opaque white body, an opaque pink cap, and are imprinted with black ink. The cap is imprinted with “Temodal”. The body is imprinted with “100 mg”, the Schering-Plough logo and two stripes.

The 140 mg hard capsules have an opaque white body, a blue cap, and are imprinted with black ink. The cap is imprinted with “Temodal”. The body is imprinted with “140 mg”, the Schering-Plough logo and two stripes.

The 180 mg hard capsules have an opaque white body, an opaque orange cap, and are imprinted with black ink. The cap is imprinted with “Temodal”. The body is imprinted with “180 mg”, the Schering-Plough logo and two stripes.

The 250 mg hard capsules have an opaque white body and cap, and are imprinted with black ink. The cap is imprinted with “Temodal”. The body is imprinted with “250 mg”, the Schering-Plough logo and two stripes.

Temodal 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.

Temodal should only be prescribed by physicians experienced in the oncological treatment of brain tumours.

Anti-emetic therapy may be administered (see section 4.4).

Posology

Adult patients with newly-diagnosed glioblastoma multiforme

Temodal is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).

Concomitant 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