Temodal Capsule 20 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 radiotherapy, after which it may be administered alone for up to 6 cycles. - During 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, based on hematologic and nonhematologic toxicity criteria, evaluate weekly whether treatment with this drug should be delayed or discontinued. 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 of grade 1 or less according to the Common Toxicity Criteria (CTC), excluding alopecia, nausea, and vomiting A 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 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 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 of grade 1 or less according to the CTC (excluding alopecia, nausea, and vomiting). - As monotherapy: After 4 weeks have elapsed following completion of the period of combination treatment with this drug and radiotherapy, 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 nonhematologic toxicity is grade 2 or less according to the CTC (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 increasing the dose to 200 mg/m2, maintain this dose for the first 5 days of each cycle unless toxicity occurs. Dose reductions and treatment discontinuation during the monotherapy period are determined based on Tables 2 and 3. A 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 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 no toxicity occurs 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 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 received prior chemotherapy, administer 200 mg/m2 orally once daily for 5 days, followed by a 23-day rest period, for a total of 28 days per 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 from the second cycle and administer for 5 days. (See 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. Take the prescribed dose using 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 who are allergic to the active ingredient or excipients, or who are hypersensitive to the specific medication dacarbazine. It can be potentially harmful to women who are pregnant or may become pregnant, or to those with severe bone marrow suppression. Additionally, it contains lactose, and patients with lactose intolerance or related genetic disorders should not take it. If the patient's general health status is very poor or if there are other serious diseases or infections, the benefits and risks of this medication should be carefully considered. This drug can cause various side effects, including infections, decreased blood cells, loss of appetite, headache, dizziness, nausea, vomiting, and hair loss. Especially due to decreased blood cells, the risk of infection may increase, so regular blood tests are necessary, and dosage adjustments may be required in severe cases. This medication may affect liver and kidney function, so liver function tests should be regularly performed before and during administration. Nausea and vomiting are common, so antiemetics may be used if necessary, and caution should be exercised when driving or operating machinery due to possible fatigue or drowsiness. Taking it with food may reduce its effectiveness, so it is better to take it on an empty stomach. Pregnant women should not use this drug, and women of childbearing age should avoid pregnancy, while men are also advised to avoid pregnancy during and for a certain period after treatment. Women who are breastfeeding should discontinue breastfeeding if taking this medication. Seniors over 70 are at higher risk of decreased blood cells, so extra caution is needed. In case of overdose, severe hematological side effects and organ failure may occur, so immediate consultation with medical personnel is necessary, and supportive therapy may be required. If the capsule is damaged, care should be taken to avoid contact of the contents with skin or mucous membranes, and if contact occurs, immediately wash with clean water. Keep out of reach of children, and store in the original container to maintain the quality and safety of the medication.

• oral candidiasis
• herpes simplex
• infection
• pharyngitis
• wound infection
• herpes zoster
• influenza-like illness
• leukopenia
• lymphocytopenia
• neutropenia

This medication is sensitive to light, so it should be stored in an opaque container. Additionally, it should be kept at room temperature between 1 degree and 30 degrees Celsius. This helps to maintain the medication's effectiveness.

Appearance

A hard capsule with a dark yellow upper and lower part containing white to pale yellow-pink powder

Package unit

5 capsules/bottle