Temodal 100 mg Capsule (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, after which it may be repeatedly 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, 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 therapy 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 lower according to the Common Toxicity Criteria (CTC), excluding alopecia, nausea, and vomiting Complete blood counts (CBC) should be 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 therapy period. Table 1. Delay or discontinuation of treatment with this drug when administered in combination 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 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 of grade 1 or lower 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 nonhematologic toxicity is grade 2 or lower 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, 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 reductions and discontinuation during monotherapy should be determined according to Tables 2 and 3. Perform a complete blood count (CBC) on day 22 of treatment (21 days after the first dose), and determine dose reduction or discontinuation of this drug according to Table 3. Table 2. Dose levels 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 treatment with 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 previously received 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 previously received chemotherapy, the initial dose is 150 mg/m2 orally once daily; if there is no hematologic toxicity, increase the dose to 200 mg/m2 once daily beginning 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 the capsules. 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 medicine should not be used in patients who are allergic to the active ingredient or excipients. It should also not be administered to patients with allergies to specific medications or those with severe bone marrow suppression. Women who are pregnant or capable of becoming pregnant should not use this medicine. It should not be administered to patients with genetic lactose-related disorders. If the patient's condition is very poor or they have other serious illnesses, the doctor will carefully weigh the benefits and risks of administering this medication. There may be an increased risk of infection when administered, so close monitoring for signs of infection is necessary. Routine blood tests are required as blood cell counts may decrease. Various side effects such as nausea, vomiting, headache, fatigue, hair loss, and rash may occur, so patients should immediately consult medical professionals if any unusual symptoms arise. This medicine may impact liver and kidney function, thus liver function tests should be conducted regularly before and during treatment. During treatment, medications to prevent nausea and vomiting can be used concurrently. Use during pregnancy is prohibited, and women of childbearing age should use effective contraception for at least 6 months during and after treatment. Men should also use contraception for at least 3 months during and after treatment and should be counseled about the potential for infertility. This medicine is not recommended for nursing mothers, and breastfeeding should be discontinued during treatment. Caution is needed in children, especially those under 3 years old, due to lack of experience with use in this population. Elderly patients are at a higher risk of decreased blood cell counts and should use the medication with extra caution. In case of overdose, severe hematological side effects and multi-organ failure may occur, requiring immediate emergency treatment. Care should be taken to avoid contact between the capsule contents and skin or mucous membranes if the capsule is damaged; if contact occurs, wash immediately. Store in a location out of reach of children, and keep in the original container to prevent misuse or degradation of quality.

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

This medicine is sensitive to light and should be stored in a tightly sealed container that protects it from light. It's important to maintain storage temperatures between 1 degree and 30 degrees Celsius at room temperature. This will help ensure the effectiveness and safety of the medication.

Appearance

Capsule with a pink upper part and white lower part containing powder ranging from white to pale red or pale orange.

Package unit

5 capsules (1 capsule/pack x 5 packs)