Temodar 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 radiotherapy, after which it may be administered alone for up to 6 cycles. - Concomitant treatment: Administer orally at 75 mg/m2 once daily for 42 days in combination with local radiotherapy (total 60 Gy delivered in 30 fractions). There is no dose reduction; instead, each week, assess whether treatment with this drug should be delayed or discontinued based on hematologic and nonhematologic toxicity criteria. Treatment with this drug may be continued during the 42-day concomitant 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) should be performed weekly during treatment. Based on the hematologic and nonhematologic toxicity criteria presented in Table 1, administration of this drug should be delayed or discontinued during the concomitant treatment period. Table 1. Delay or discontinuation of this drug during concomitant treatment with radiotherapy Toxicity Delay administration of this drug* Discontinue administration of 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 *Administration of 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 according to the CTC (excluding alopecia, nausea, and vomiting). - Monotherapy: After 4 weeks have elapsed following completion of concomitant 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 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 during 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) 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 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 administration of 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: Administration of 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 200 mg/m2 orally 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 from the second cycle and administer for 5 days. (Refer to 4. General Precautions in the Precautions for Use.) * This drug should be taken while fasting. * 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 medication should not be used in individuals with allergies to the active ingredient or excipients. It should also not be administered to those who have had prior allergic reactions to specific medications. Patients with severe bone marrow suppression, pregnant women, or women who may become pregnant should not use this medication. Additionally, patients with lactose intolerance or certain genetic metabolic disorders should avoid this medication. This medication must be used cautiously in patients who have very poor health or severe other conditions, weighing the benefits against the risks. It may cause various side effects such as infections, decreased blood cell count, loss of appetite, headache, dizziness, nausea, vomiting, and hair loss. These side effects can occur frequently, necessitating regular blood tests and health checks. Particularly, when this medication is combined with radiation therapy, the risk of infections, such as pneumonia, may increase; therefore, preventive measures should be taken. Patients with severely impaired liver or kidney function should be careful when using this medication and should undergo frequent liver function tests. Nausea and vomiting symptoms are common, so using antiemetics can help alleviate these symptoms. This medication can cause fatigue or drowsiness, so care should be taken when driving or operating machinery. Pregnant women should not take this medication, and women of childbearing age should avoid becoming pregnant. Men are advised to avoid planning a pregnancy for at least six months after treatment. Women who are breastfeeding should discontinue nursing while taking this medication. Children, especially those under 3 years of age, have insufficient experience with this medication, so caution is advised. Elderly patients are at higher risk of decreased blood cell counts and should exercise caution. Serious hematological side effects may occur in the event of an overdose, so the dosage must be strictly followed, and immediate consultation with medical professionals is necessary in case of overdose. This medication should be handled to prevent its contents from contacting the skin or mucous membranes if the capsule is damaged, and it should be stored out of reach of children. Pharmaceuticals should be stored in their original container and should not be transferred to another container for safety reasons.

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

This medication is sensitive to light, so it should be stored in a container that restricts light exposure. Additionally, it is important to keep it at room temperature, between 1 and 30 degrees Celsius, to maintain its effectiveness.

Appearance

A hard capsule with a pink upper part and a pink lower part filled with a white to pale pink or pale orange powder.

Package unit

5 capsules (5 capsules x 1)/PTP