Temozolomide Capsule 100 mg (Temozolomide)

Adult dose

1) Treatment of adults with newly diagnosed glioblastoma multiforme: For newly diagnosed glioblastoma multiforme, this drug is initially administered in combination with radiation therapy, after which it may be repeated as monotherapy for up to 6 cycles. - In 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, 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 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 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-therapy period. Table 1. Delay or discontinuation of this drug during combination therapy 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). - As monotherapy: Four weeks after completion of the combination period of this drug and radiation therapy, this drug may be administered as monotherapy for up to 6 cycles. The dose in 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 the dose has been increased to 200 mg/m2, maintain this dose during the first 5 days of each cycle unless toxicity occurs. Dose reduction and discontinuation during the monotherapy period 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 reduction due to prior 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 level of this druga 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: See Table 2 for the dose levels of this drug. b: Treatment with this drug must 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 cycle length of 28 days. 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. (See Precautions for Use 4. General Precautions.) * 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 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 that same day.

This medication should not be used in patients with an allergy to the active ingredient or excipients. Additionally, patients allergic to the specific anticancer drug dacarbazine should not be administered this drug. It should not be given to patients with severe myelosuppression, and it is prohibited for use in women who are pregnant or of childbearing potential. In patients with very poor performance status or serious concomitant illness or infections, a careful assessment of the benefits and risks of this drug should be done before deciding to administer it. This drug can cause various side effects including infections, reduction in blood cell counts, loss of appetite, headache, dizziness, nausea, vomiting, and hair loss. In particular, since there is a significant risk of bleeding or increased risk of infection due to a decrease in blood cell counts, regular blood tests are necessary. During treatment, liver and kidney functions should be periodically monitored, and if any abnormal findings are detected, the healthcare provider should be consulted immediately. This drug should be taken on an empty stomach as absorption is reduced when taken with food. Women who are pregnant or may become pregnant should not take this medication, and women of childbearing potential should avoid pregnancy during treatment. Male patients should also avoid planning for pregnancy for 6 months after treatment, and it is recommended to discuss sperm preservation prior to treatment. Extra caution is required when administering this drug to children and elderly patients, particularly those over 70 years of age, as the risk of reduced blood cell counts may be higher. In cases of overdose, severe hematological abnormalities and organ failure may occur, and immediate medical attention is required. Store this medication out of reach of children, and take care to ensure that the contents do not come into contact with skin or mucous membranes if the capsule is damaged. Also, the medication should be stored in its original container to prevent degradation of quality or misuse.

• Oral candidiasis
• herpes simplex
• infection
• pharyngitis
• wound infection
• herpes zoster
• flu-like symptoms
• leukopenia
• lymphocytopenia
• neutropenia

This medication should be stored in a light- and air-protected container at room temperature between 1 degrees and 30 degrees Celsius. Proper storage will help maintain the efficacy of the medication over time.

Appearance

A hard capsule of light pink color containing a white to pale yellowish pink powder

Package unit

5 capsules/bottle