Astrodal Capsule 100 mg (Temozolomide)

Adult dose

1) Treatment of newly diagnosed glioblastoma multiforme in adults: For newly diagnosed glioblastoma multiforme, this medicine is initially administered in combination with radiation therapy, after which it may be 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, treatment delay or discontinuation of this medicine is evaluated weekly based on hematologic and nonhematologic toxicity criteria. Treatment with this medicine may be continued for 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 or lower 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 medicine should be delayed or discontinued during the combination therapy period. Table 1. Delay or discontinuation of this medicine during combination therapy with radiation therapy Toxicity Delay treatment with this medicine* Discontinue treatment with this medicine 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 medicine 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 or lower according to the CTC (excluding alopecia, nausea, and vomiting). - Monotherapy: Four weeks after completion of the combination therapy period with this medicine and radiation therapy, this medicine 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 or lower (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 reduction and discontinuation during monotherapy 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 medicine is determined according to Table 3. Table 2. Dose of this medicine during 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 medicine during monotherapy Toxicity Reduce the dose levela of this medicine by one level Discontinue treatment with this medicine 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 medicine. b: Treatment with this medicine 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 medicine 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 under Precautions for Use.) * This medicine should be taken in a fasting state. * Take this medicine 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 medicine. If vomiting occurs after taking this medicine, do not take a second dose on the same day.

This medication should not be used in patients with allergies to the active ingredient or excipients. Additionally, patients allergic to the specific drug dacarbazine or those with severe bone marrow suppression should not receive this medication. Pregnant or potentially pregnant women should not take this medication, and caution is required in patients with genetic issues such as lactose intolerance. This medication should be used with caution in patients with very poor physical status or other serious illnesses, and those allergic to specific pigment components should also be cautious. Various side effects may occur when taking this medication, including infection, decreased blood cell counts, loss of appetite, headache, dizziness, nausea, vomiting, hair loss, and skin rash, so regular testing and observation are necessary. In particular, blood cell counts may significantly decrease, so dosage adjustments may be required based on blood test results. Long-term use of this medication or use in conjunction with steroids can increase the risk of opportunistic infections such as pneumonia, so preventive measures must be undertaken. Patients with poor liver or kidney function should undergo regular liver function tests before and after taking this medication, as there is a risk of liver damage. Severe nausea or vomiting may occur during treatment, and antiemetics may be used if needed. This medication can cause fatigue or drowsiness, so caution should be taken when driving or operating machinery. Women who are pregnant or breastfeeding should not use this medication, and male patients should avoid pregnancy during and for a certain period after treatment. In children or the elderly, the experience of use is limited or there is a high risk of side effects, so it should be used cautiously after consultation with medical personnel. In cases of overdose, serious hematological side effects may arise, requiring immediate evaluation and treatment by medical personnel. This medication should be stored in its original container, and care should be taken to prevent contact between the contents and skin or mucous membranes if the capsules are damaged. It is also important to keep it out of the reach of children.

• oral candidiasis
• herpes simplex
• infection
• 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 prevents light exposure. Additionally, to maintain the efficacy of the medication, it is important to store it at room temperature between 1 and 30 degrees Celsius.

Appearance

A pink capsule with an upper orange part and a lower white part containing a white to almost white powder.

Package unit

5 capsules (1 capsule/pack x 5)