Temodal Dosage/Direction for Use

Adult patients with newly diagnosed glioblastoma multiforme: Concomitant phase: TEMODAL is administered orally at 75 mg/m² daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions) followed by adjuvant TEMODAL for 6 cycles. No dose reductions are recommended; however, dose interruptions may occur based on patient tolerance. The TEMODAL dose can be continued throughout the 42-day concomitant period up to 49 days if all of the following conditions are met: absolute neutrophil count ≥1.5 x 10⁹/L; thrombocyte count ≥100 x 10⁹/L; common toxicity criteria (CTC) non-hematological toxicity ≤Grade 1 (except for alopecia, nausea and vomiting). During treatment, a complete blood count should be obtained weekly. TEMODAL dosing should be interrupted or discontinued during concomitant phase according to the hematological and non-hematological toxicity criteria as noted in Table 1. (See Table 1.)

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Adjuvant Phase: Four weeks after completing the TEMODAL + Radiotherapy phase, TEMODAL is administered for an additional 6 cycles of adjuvant treatment. Dosage in Cycle 1 (adjuvant) is 150 mg/m² once daily for 5 days followed by 23 days without treatment. At the start of Cycle 2, the dose is escalated to 200 mg/m² if the CTC non-hematologic toxicity for Cycle 1 is Grade ≤2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is ≥1.5 x 10⁹/L, and the thrombocyte count is ≥100 x 10⁹/L. If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles. The dose remains at 200 mg/m² per day for the first 5 days of each subsequent cycle except if toxicity occurs. Dose reductions during the adjuvant phase should be applied according to Tables 2 and 3.
During treatment, a complete blood count should be obtained on Day 22 (21 days after the first dose of TEMODAL). The TEMODAL dose should be reduced or discontinued according to Table 3. (See Tables 2 and 3.)

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Adults with recurrent or progressive malignant glioma: In patients previously untreated with chemotherapy, TEMODAL is administered orally at a dose of 200 mg/m² once daily for 5 days per 28-day cycle. In patients previously treated with chemotherapy, the initial dose is 150 mg/m² once daily, to be increased in the second cycle to 200 mg/m² daily providing the absolute neutrophil count (ANC) is ≥1.5 x 10⁹/L and the thrombocyte count is ≥100 x 10⁹/L on Day 1 of the next cycle.
Adults with Metastatic malignant melanoma: For patients with metastatic malignant melanoma, the recommended dose is 200 mg/m² once daily for 5 days per 28-day cycle.
Pediatric patients with recurrent or progressive malignant glioma: In patients 3 years of age or older, TEMODAL is administered orally at a dose of 200 mg/m² once daily for 5 days per 28-day cycle. Pediatric 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 hematologic toxicity.
Laboratory parameters for dose modification in recurrent or progressive malignant glioma, or malignant melanoma: Patients treated with TEMODAL may experience myelosuppression, including prolonged pancytopenia, which may result in aplastic anemia, which in some cases has resulted in a fatal outcome. In some cases, exposure to concomitant medications associated with aplastic anemia, including carbamazepine, phenytoin, and sulfamethoxazole/trimethoprim, complicates assessment. Prior to dosing, the following laboratory parameters must be met: absolute neutrophil count (ANC) ≥1.5 x 10⁹/L and platelets ≥100 x 10⁹/L. A complete blood count must be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until ANC is above 1.5 x 10⁹/L and platelet count exceeds 100 x 10⁹/L. If the ANC falls to <1.0 x 10⁹/L or the platelet count is <50 x 10⁹/L during any cycle, the next cycle should be reduced one dose level. Dose levels include 100 mg/m², 150 mg/m², and 200 mg/m². The lowest recommended dose is 100 mg/m².
All Patients: TEMODAL should be administered in the fasting state, at least one hour before a meal.
TEMODAL Capsules must not be opened or chewed, but are to be swallowed whole with a glass of water. If a capsule becomes damaged, avoid contact of the powder contents with skin or mucous membrane.