Temozolomide Capsule 20mg (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 therapy: 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, assess weekly whether treatment with this drug should be delayed or discontinued. This drug may be continued throughout 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) 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 this drug during combination therapy 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 *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). - Monotherapy: After 4 weeks have elapsed following completion of the combination therapy period 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 (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 the dose has been increased to 200 mg/m2, maintain this dose for the first 5 days of each cycle unless toxicity occurs. During the monotherapy period, dose reduction and discontinuation are determined based on Tables 2 and 3. A complete blood count (CBC) should be performed on day 22 after starting 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 for 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: See 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 beginning 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 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 with an allergy to the active ingredient or excipients. In particular, caution should be exercised for patients allergic to a drug called dacarbazine. It is safe to avoid use in patients with severe bone marrow suppression. Women who are pregnant or could become pregnant should not take this medication. It also contains lactose, which may pose a risk to patients with lactose intolerance or certain genetic metabolic disorders. Patients with poor performance status or serious other diseases or infections should carefully weigh the benefits and risks of administering this medication. Various side effects may occur while taking this medication. The risk of infection may increase, and blood cell counts may decrease, increasing the risk of anemia or bleeding. Gastrointestinal symptoms such as nausea, vomiting, and constipation can commonly occur, along with neurological symptoms such as headache, dizziness, and drowsiness. Symptoms such as skin rash, hair loss, muscle pain, and joint pain have also been reported. Liver function abnormalities may occur, so liver function tests must be conducted before and during treatment, and dosage should be adjusted or stopped if liver damage is observed. Serious infections such as pneumonia may occur with prolonged use of this medication or concurrent radiation therapy, so preventive measures are necessary. Taking this medication with food may reduce absorption, so it is advisable to take it on an empty stomach. During the treatment, frequent blood tests should be performed to monitor white blood cell and platelet counts for bone marrow suppression, and the dose should be reduced if the counts decline. This medication may cause fatigue or drowsiness, so caution is needed when driving or operating machinery. Pregnant women should not take this medication, and women of childbearing potential should avoid pregnancy. Male patients should avoid pregnancy with their partners during treatment and for 6 months afterward and should consider sperm preservation before treatment. Breastfeeding individuals should discontinue breastfeeding while taking this medication. The safety of this medication in children under the age of 3 has not been established, and experiences in children and adolescents over 3 years of age are limited. Elderly patients aged 70 and over are at higher risk for a decrease in blood cells and should be more closely monitored. In the event of an overdose, severe bone marrow suppression and multi-organ failure may occur, so medical personnel should be notified immediately, and appropriate treatment should be provided if necessary. Care should be taken to prevent breaking capsules and exposing the contents to the skin or mucous membranes, and if contact occurs, it should be washed off immediately with clean water. Store out of reach of children, and keep medications in their original containers and sealed.

• Oral candidiasis
• herpes simplex
• infection
• pharyngitis
• wound infection
• shingles
• influenza-like symptoms
• leukopenia
• lymphocytopenia
• neutropenia

This medication is sensitive to light and should be stored in a container that does not allow light to enter. Additionally, it is best to store the medication at room temperature between 1°C and 30°C. This will help maintain the drug's effectiveness.

Appearance

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

Package unit

5 capsules (5 capsules x 1) / PTP