Temodal Capsule 20 Milligrams (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 radiotherapy, after which this drug may be administered repeatedly as monotherapy for up to 6 cycles. Combination treatment: Administer orally at 75 mg/m2 once daily for 42 days in combination with local radiotherapy (a total of 60 Gy divided into 30 fractions). There is no dose reduction; instead, whether to delay or discontinue treatment with this drug is assessed weekly based on hematologic and nonhematologic toxicity criteria. Treatment with this drug may continue 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 or lower 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 shown 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 radiotherapy 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 criteria are met: absolute neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, and nonhematologic toxicity level 1 or lower according to the CTC (excluding alopecia, nausea, and vomiting). Monotherapy: After 4 weeks have elapsed following completion of combination treatment with this drug and radiotherapy, this drug may be administered as monotherapy 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 or lower (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. During the monotherapy period, dose reductions and discontinuation are determined based on 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 for 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 / b See below 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 and anaplastic astrocytoma in adults who have failed standard therapy: For patients who have not previously received chemotherapy, administer 200 mg/m2 orally once daily for 5 days, followed by a 23-day rest period; 28 days in total constitute one cycle. For patients who have previously received 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 in a fasting state. Take this drug with water. Do not open or chew it. When taking the prescribed dose, use the fewest 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 medication should not be administered to patients who have had an allergic reaction to the active ingredient or excipients. Patients with allergies to other specific drugs should also avoid using this medication. It may be dangerous to administer this medication to patients with severe bone marrow suppression. Women who are pregnant or may become pregnant should not use this medication. This medication contains lactose and is unsuitable for patients with lactose intolerance or certain genetic metabolic disorders. For patients with poor performance status or severe other diseases or infections, the benefits and risks of this medication should be carefully considered before administration. Using this medication may cause various side effects, including infections, reduced blood cell counts, loss of appetite, headache, dizziness, nausea, vomiting, hair loss, fatigue, etc. Regular blood tests are necessary, especially due to the increased risk of bleeding or infections resulting from reduced blood cell counts. During the administration of this medication, there is a risk of opportunistic infections such as Pneumocystis jirovecii pneumonia and reactivation of hepatitis B virus, so prevention and monitoring are essential. Patients with liver or kidney dysfunction should undergo liver function tests before and after administration of this medication, and careful consideration must be given to whether to continue administration if abnormalities are noted. Taking this medication with food may reduce absorption, so it is advisable to take it on an empty stomach. Additionally, caution is needed when used with other myelosuppressive agents, as side effects may worsen. Women who are pregnant or breastfeeding should not use this medication, and fertile women and men should ensure effective contraception during and for some time after treatment. There is insufficient safety information regarding the use of this medication in children, especially infants under 3 years of age, so caution is required during use. Elderly patients may have a higher risk of reduced blood cell counts and should be administered this medication with extra care. Overdose may result in severe hematological side effects and multi-organ dysfunction, so if an overdose is suspected, seek medical attention immediately and receive appropriate treatment. If the capsule of this medication is damaged, take care to avoid contact with skin or mucous membranes, and if contact occurs, wash immediately with water. Keep out of reach of children and store medications in their original containers tightly sealed.

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

This medication is sensitive to light and should be stored in a tightly sealed container that blocks light. Additionally, it should be stored at room temperature between 1 degree and 30 degrees Celsius, avoiding excessively hot or cold places.

Appearance

Capsule with yellow upper part and white lower part containing white to light pink or light orange powder

Package unit

5 capsules (1 capsule/pack x 5 packs)