Temozolomide 250 mg Capsule

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, after which it may be administered alone for up to 6 cycles. - Combination therapy: Administer orally at 75 mg/m2 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, the decision to delay or discontinue treatment with this drug is assessed weekly based on hematologic and nonhematologic toxicity criteria. Treatment with this drug may be continued during the 42-day combination treatment period (up to a maximum of 49 days) only if all of the following criteria are met. ① 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), excluding alopecia, nausea, and vomiting A complete blood count (CBC) is performed weekly during the treatment period. Based on the hematologic and nonhematologic toxicity criteria presented in Table 1, treatment with this drug should be delayed or discontinued during the combination treatment period. Table 1. Delay or discontinuation of this drug during combination treatment 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 completion of the combination treatment period 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, it should not be increased in subsequent cycles. After the dose has been increased to 200 mg/m2, maintain this dose for the first 5 days of each cycle unless toxicity occurs. During monotherapy, dose reduction and discontinuation are determined according to Tables 2 and 3. A complete blood count (CBC) is performed on Day 22 of treatment (21 days after the first dose), and dose reduction or discontinuation of this drug is determined according to Table 3. Table 2. Dose of this drug for monotherapy Dose level Dose (mg/m2/day) Description -1 100 Dose reduced due to previous 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 the dose levela of this drug by one level 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. ㆍ Unacceptable toxicity occurs even at dose level -1 (100 mg/m2/day) ㆍ 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 and 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; a total of 28 days constitutes 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. (Refer to 4. General Precautions under Precautions for Use.) * This drug should be taken on an empty stomach. * Take this drug with water. Do not open or chew the capsules. When taking the prescribed dose, use the minimum number of capsules possible. * Antiemetics may be taken before or after this drug. If vomiting occurs after taking this drug, do not take a second dose on the same day.

This medication should not be administered to patients who have allergies to the active ingredient or excipients, or to those who have had an allergic reaction to the specific chemotherapy agent dacarbazine. Additionally, it should not be used in patients with severe bone marrow suppression or in pregnant or potentially pregnant women. The decision to administer this medication should be made cautiously in patients with poor overall health or who have other serious illnesses or infections. This medication can affect the immune system and increase the risk of infection, so symptoms of infection should be closely monitored during treatment. Bone marrow suppression may result in decreased blood cell counts, requiring regular blood tests to monitor the condition and adjust the dosage if necessary. While taking this medication, various side effects such as nausea, vomiting, loss of appetite, fatigue, headache, dizziness, hair loss, and skin rash may occur, and immediate consultation with healthcare professionals is advised if any abnormal symptoms appear. Patients with liver or kidney function problems should undergo function tests before taking this medication, and regular testing should be carried out during treatment, with discontinuation or adjustment of the dosage if there are severe liver abnormalities. This medication can be harmful to the fetus during pregnancy, so women who are pregnant or planning to become pregnant should avoid it, and male patients should avoid pregnancy for a period after treatment ends. Breastfeeding women should discontinue nursing as there is a possibility of this medication being transmitted through breast milk. Special precautions should be taken when administering this medication to children or elderly patients, especially the elderly, who are at a higher risk of decreased blood cell counts, making regular testing important. In cases of overdose, serious hematological side effects and organ failure may occur, and immediate contact with a medical institution for appropriate treatment is necessary. This medication may reduce absorption when taken with food, so it is recommended to take it on an empty stomach, and potential interactions with other medications should be disclosed to healthcare professionals. Patients should be cautious during driving or operating machinery, as drowsiness or fatigue may occur. Lastly, care should be taken to avoid contact between the capsule contents and skin or mucous membranes in case of damage, and it should be kept out of reach of children and stored in its original container.

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

This medication is sensitive to light and should be stored in a container that does not allow light in. Additionally, it is important to store it at room temperature between 1°C and 30°C to maintain its effectiveness.

Appearance

A hard yellow capsule containing a white to pale yellow powder.

Package unit

5 capsules per bottle