Temodal Capsule 250 mg (Temozolomide)

Adult dose

1) Treatment of newly diagnosed glioblastoma multiforme in adults: For newly diagnosed glioblastoma multiforme, this drug is initially administered in combination with radiation therapy, and may subsequently be administered alone for up to 6 cycles. - Combination therapy: Administer orally at 75 mg/m2 once daily for 42 days in combination with local radiation therapy (a total of 60 Gy divided into 30 fractions). There is no dose reduction; instead, each week, evaluate whether to delay or discontinue treatment with this drug based on hematologic and nonhematologic toxicity criteria. Treatment with this drug may be continued during the 42-day combination-therapy period (up to a maximum of 49 days) only if all of the following criteria are met. ① Absolute neutrophil count (Absolute Neutrophil Count ; ANC) ≥ 1.5 x 109/L ② Platelet count ≥ 100 x 109/L ③ Nonhematologic toxicity level ≤ 1 according to the Common Toxicity Criteria (CTC : Common Toxicity Criteria) (excluding alopecia, nausea, and vomiting) A complete blood count (complete blood count; CBC) should be performed weekly during treatment. Based on the hematologic and nonhematologic toxicity criteria presented in Table 1, treatment with this drug should be delayed or discontinued during the combination-therapy period. Table 1. Delay or discontinuation of this drug during combination therapy with radiation therapy Toxicity Delay treatment with this drug* Discontinue treatment with this drug Absolute neutrophil count (ANC) ≥0.5 and <1.5 x 109/L <0.5 x 109/L Platelet count ≥10 and <100 x 109/L <10 x 109/L Nonhematologic toxicity level according to the Common Toxicity Criteria (CTC) (excluding alopecia, vomiting, and nausea) CTC grade 2 CTC grade 3 or 4 *Treatment with this drug may be resumed when all of the following conditions are met: absolute neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, and nonhematologic toxicity level ≤ 1 according to the CTC (excluding alopecia, nausea, and vomiting). - Monotherapy: After 4 weeks have elapsed following the end of combination therapy with this drug and radiation therapy, this drug may be administered alone for up to 6 cycles. The dose for cycle 1 is 150 mg/m2 for 5 days, followed by a 23-day rest period. At the start of cycle 2, increase the dose to 200 mg/m2 if the nonhematologic toxicity level according to the CTC is ≤ 2 (excluding alopecia, nausea, and vomiting), the absolute neutrophil count is ≥ 1.5 x 109/L, and the platelet count is ≥ 100 x 109/L. If the dose is not increased at the start of cycle 2, do not increase it in subsequent cycles. After increasing the dose to 200 mg/m2, maintain this dose for the first 5 days of each cycle unless toxicity occurs. Dose reduction and discontinuation during monotherapy should be determined according to Tables 2 and 3. A complete blood count (complete blood count ; CBC) should be performed on day 22 of treatment (21 days after the first dose), and dose reduction or discontinuation of this drug should be determined according to Table 3. Table 2. Dose of this drug during monotherapy Dose level Dose (mg/m2/day) Description -1 100 Dose reduced due to prior toxicity 0 150 Dose administered in cycle 1 1 200 Dose administered in cycles 2-6 if there is no toxicity Table 3. Delay or discontinuation of this drug during monotherapy Toxicity Reduce this drug by one dose levela Discontinue treatment with this drug Absolute neutrophil count (ANC) <1.0 x 109/L See b Platelet count <50 x 109/L Nonhematologic toxicity level according to the Common Toxicity Criteria (CTC) (excluding alopecia, vomiting, and nausea) CTC grade 3 CTC grade 4b a: Refer to Table 2 for the dose levels of this drug. b: Treatment with this drug should be discontinued in the following cases. • Unacceptable toxicity occurs even at dose level -1 (100 mg/m2/day) • Grade 3 nonhematologic toxicity (excluding alopecia, nausea, and vomiting) occurs even after dose reduction of this drug 2) Treatment of recurrent or progressive glioblastoma multiforme (Glioblastoma multiforme) and anaplastic astrocytoma (Anaplastic astrocytoma) in adults who have failed standard therapy: For patients who have not received prior chemotherapy, administer orally 200 mg/m2 once daily for 5 days, followed by a 23-day rest period; the total 28 days constitute one cycle. For patients who have received prior chemotherapy, the initial dose is 150 mg/m2 once daily; if there is no hematologic toxicity, increase the dose to 200 mg/m2 once daily starting with the second cycle and administer for 5 days. (See Precautions for Use 4. General Precautions.) * This drug should be taken on an empty stomach. * Take this drug with water; do not open or chew it. When taking the prescribed dose, use the minimum number of capsules possible. * Antiemetics may be taken before or after taking this drug. If vomiting occurs after taking this drug, do not take a second dose on the same day.

This drug should not be administered to patients with allergies to the active ingredient or excipients. It should also not be used in patients with allergies to other specific medications or severe bone marrow suppression. Pregnant or potentially pregnant women should not use this drug, as it contains lactose and should not be administered to patients with certain hereditary metabolic disorders. Careful consideration of the benefits and risks of treatment is necessary if the patient's condition is very poor or if they have serious other illnesses. Using this medication may increase the risk of infections, and side effects such as decreased blood cell counts are common. Various side effects such as headaches, dizziness, nausea, vomiting, hair loss, and fatigue can occur, so consultation with healthcare professionals is needed if symptoms arise. This medication may weaken the immune system, increasing the risk of specific pneumonia or viral infections, necessitating preventive measures and regular examinations. Patients with poor liver or kidney function should consult with healthcare professionals before use, and discontinuation or dosage adjustment may be necessary in cases of hepatic dysfunction. Antiemetics may be used to reduce nausea and vomiting while taking this medication. Blood tests should be conducted regularly to monitor blood cell counts, and dosage adjustment is necessary if blood cell counts become too low. Fatigue or drowsiness may occur, so caution is advised when driving or operating machinery. Taking this medication with food may decrease its efficacy, so it is advisable not to take it with food. Pregnant or breastfeeding women should avoid using this medication, and male patients should use effective contraceptive methods during treatment and for a period afterward. Special caution is needed for children and elderly patients, as the elderly may be at a higher risk for decreased blood cell counts. In the case of overdose, serious blood abnormalities and multi-organ failure may occur, and medical attention should be sought immediately, with supportive treatment as necessary. When storing the medication, care should be taken to prevent damage to the capsules, and they should be kept out of reach of children, ideally stored in the original container.

• oral candidiasis
• herpes simplex
• infection
• pharyngitis
• wound infection
• herpes zoster
• influenza-like symptoms
• leukopenia
• lymphopenia
• neutropenia

This drug is sensitive to light and should be stored in an airtight container that blocks light. Additionally, it is important to maintain a room temperature between 1 to 30 degrees Celsius while storing the medication, which helps maintain its efficacy and prevent degradation.

Appearance

White capsule containing white powder that is off-white to light reddish or light orange.

Package unit

5 capsules (1 capsule/packet x 5 packets)