Astrodal 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 concomitantly with radiotherapy, after which it may be administered alone for up to 6 cycles. - Concomitant treatment: Administer orally at a dose of 75 mg/m2 once daily for 42 days concomitantly with local radiotherapy (a total of 60 Gy in 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. Treatment with this drug may continue 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 of grade 1 or lower 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 concomitant treatment period. Table 1. Delay or discontinuation of this drug during concomitant 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 grade 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: Monotherapy with this drug may be given for up to 6 cycles, starting 4 weeks after completion of concomitant treatment with this drug and radiotherapy. The dose for cycle 1 is 150 mg/m2 once daily for 5 days, followed by 23 days without treatment. 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, it should not be increased in subsequent cycles. After an increase to 200 mg/m2, maintain this dose for the first 5 days of each cycle unless toxicity occurs. Dose reduction and discontinuation during monotherapy should be determined according to 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 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 Refer to b Platelet count <50 x 109/L Nonhematologic toxicity grade 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. 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 23 days without treatment; the total 28 days constitute 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 starting with the second cycle and administer for 5 days. (Refer to 4. General Precautions in Precautions for Use.) * This drug should be taken in a fasted state. * Take this drug with water. Do not open or chew it. When taking the prescribed dose, use the fewest capsules possible. * An antiemetic 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 a hypersensitivity to the active ingredient or excipients. Patients with hypersensitivity to dacarbazine should also avoid this medication. It should not be used in patients with severe myelosuppression, and women who are pregnant or may become pregnant should not take this medication. This medication contains lactose and should not be given to patients with lactose intolerance or related genetic issues. Patients with poor performance status or serious diseases or infections should carefully weigh the benefits and risks of using this medication. This medication can cause various side effects including infections, blood abnormalities, endocrine problems, metabolic issues, CNS and neurological problems, eye and ear anomalies, cardiovascular issues, respiratory symptoms, gastrointestinal disturbances, skin anomalies, musculoskeletal issues, renal and reproductive abnormalities, etc. Particularly, due to myelosuppression, neutropenia and thrombocytopenia may occur frequently, increasing the risk of infections and bleeding. This medication could lower immunity and may lead to opportunistic infections, and there is a risk of reactivation of hepatitis B or cytomegalovirus infections, thus appropriate testing is required before and during treatment. Patients with impaired liver and kidney functions should be cautious when using this medication and should carefully evaluate the continuation of treatment if liver function is abnormal. Nausea and vomiting may commonly occur during treatment; antiemetics may be used as needed to control these symptoms. Due to myelosuppression, blood counts need to be monitored frequently, and if blood levels drop below certain thresholds, the dosage should be reduced. This medication may cause fatigue and drowsiness; caution is required while driving or operating machinery. Taking this medication with food may decrease its effectiveness, so it is recommended to take it on an empty stomach. Pregnant women should not take this medication as it may harm the fetus, and women of childbearing potential should avoid becoming pregnant. Men should be careful to prevent their partners from becoming pregnant for 6 months after treatment, and it is advisable to consult about sperm preservation before treatment. It is unknown whether this medication is transferred through breast milk, so nursing mothers should discontinue breastfeeding. There is no experience in using this medication in children under 3 years of age, and elderly patients are at a higher risk for blood abnormalities side effects, so caution is necessary. In case of overdose, serious hematological side effects and multiple organ failure may occur, and immediate medical attention should be sought. If the capsule is damaged, care should be taken to avoid contact of the contents with skin or mucous membranes, and if contact occurs, wash immediately with clean water. Store out of the reach of children, and keep it sealed in the original container.

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

This medication should be kept in a container that protects it from light and air, and it is advisable to store it at room temperature between 1 to 30 degrees Celsius. Proper storage can maintain the efficacy of the medication for a longer period.

Appearance

Capsule containing a white to nearly white powder with a dark yellow upper part and a white lower part.

Package unit

5 capsules (1 capsule/pack x 5)