Gilotip Tablet 400mg (Imatinib Mesylate)

Adult dose

Chronic myeloid leukemia (CML) in adults: A dose of 400mg once daily is recommended for patients with Philadelphia chromosome-positive chronic-phase chronic myeloid leukemia. A dose of 600mg once daily is recommended for patients with Philadelphia chromosome-positive accelerated-phase or blast-phase chronic myeloid leukemia. In the following cases, if there are no severe adverse reactions or severe leukemia-unrelated neutropenia or thrombocytopenia, an increase from 400mg to 600mg in adult patients with chronic-phase disease, or from 600mg to 800mg (400mg twice daily) in adult patients with accelerated-phase or blast-phase disease, may be considered. (1) Disease progression (at any time) (2) Failure to achieve a satisfactory hematologic response after at least 3 months of treatment (3) Failure to achieve a cytogenetic response after 6-12 months of treatment (4) Loss of a previously achieved hematologic or cytogenetic response Myelodysplastic syndrome/myeloproliferative disease: A dose of 400mg once daily is recommended. Hypereosinophilic syndrome/chronic eosinophilic leukemia: A dose of 100mg once daily is recommended. The dose may be increased to 400mg once daily. Recurrent or metastatic dermatofibrosarcoma protuberans: 800mg once daily (400mg twice daily) The prescribed dose should be taken with a meal and plenty of water to minimize the risk of gastrointestinal irritation. The 400mg or 600mg dose is taken once daily, and the 800mg dose is taken as 400mg twice daily. Although no specific pharmacokinetic studies of this drug have been conducted in elderly patients, no significant age-related pharmacokinetic differences were observed in approximately 20% of patients aged 65 years or older who participated in clinical trials. There is no specific recommended dose for elderly patients. Reduce the adult dose from 400mg to 300mg, or from 600mg to 400mg, or from 800mg to 600mg. Hypereosinophilic syndrome and chronic eosinophilic leukemia (starting dose 100mg): If ANC < 1.0 × 109/L and/or platelets < 50 × 109/L, interrupt treatment with this drug until ANC ≥ 1.5 × 109/L and platelet count ≥ 75 × 109/L. Resume treatment with this drug at the previous dose (the dose before the severe adverse reaction occurred). Chronic-phase chronic myeloid leukemia, myelodysplastic syndrome/myeloproliferative disease, hypereosinophilic syndrome/chronic eosinophilic leukemia (dose 400mg): If ANC < 1.0 × 109/L and/or platelets < 50 × 109/L, interrupt treatment with this drug until ANC ≥ 1.5 × 109/L and platelet count ≥ 75 × 109/L. Resume treatment with this drug at the original starting dose of 400mg. If ANC < 1.0 × 109/L and/or platelet count again falls to < 50 × 109/L, repeat step 1 and resume treatment at the reduced dose of 300mg. Accelerated-phase or blast-phase chronic myeloid leukemia (starting dose 600mg): If ANC < 0.5 × 109/L and/or platelets < 10 × 109/L, determine whether the cytopenia is related to leukemia (bone marrow aspiration or biopsy). If the cytopenia is not related to leukemia, reduce the dose of this drug to 400mg. If the cytopenia persists for 2 weeks, reduce the dose further to 300mg. If the cytopenia persists for 4 weeks and is still not related to leukemia, interrupt treatment with this drug until ANC ≥ 1 × 109/L and platelet count ≥ 20 × 109/L, then resume treatment at a dose of 300mg. Dermatofibrosarcoma protuberans (starting dose 800mg): If ANC < 1.0 × 109/L and/or platelets < 50 × 109/L, interrupt treatment with this drug until ANC ≥ 1.5 × 109/L and platelet count ≥ 75 × 109/L. Resume treatment with this drug at 600mg. If ANC < 1.0 × 109/L and/or platelet count again falls to < 50 × 109/L, repeat step 1 and resume treatment at the reduced dose of 400mg. For severe neutropenia and thrombocytopenia occurring after at least 1 month of treatment, dose reduction or treatment interruption is recommended as follows.

Child dose

For patients with Philadelphia chromosome-positive chronic-phase, accelerated-phase, or blast-phase chronic myeloid leukemia, a dose of 340mg/m2 per day based on body surface area is recommended (not exceeding a total daily dose of 600mg). The dose may be administered once daily or divided into 2 doses, in the morning and evening. Pediatric patients may take this medicine once daily or, optionally, divide the daily dose into 2 doses taken in the morning and evening. The pediatric dose is reduced from 340mg/m2 to 260mg/m2, or from 260mg/m2 to 200mg/m2. Pediatric chronic-phase chronic myeloid leukemia (starting dose 340mg/m2): If ANC < 1.0 × 109/L and/or platelets < 50 × 109/L, interrupt treatment with this medicine until ANC ≥ 1.5 × 109/L and platelet count ≥ 75 × 109/L. Resume treatment at the previous dose (before the occurrence of the severe adverse reaction). If ANC < 1.0 × 109/L and/or platelet count falls below < 50 × 109/L again, repeat step 1 and resume treatment at the reduced dose of 260mg/m2. Pediatric accelerated-phase or blast-phase chronic myeloid leukemia (starting dose 340mg/m2): If ANC < 0.5 × 109/L and/or platelets < 10 × 109/L, determine whether the cytopenia is related to leukemia (bone marrow aspiration or biopsy). If the cytopenia is not related to leukemia, reduce the dose of this medicine to 260mg/m2. If the cytopenia persists for 2 weeks, reduce the dose further to 200mg/m2. If the cytopenia persists for 4 weeks and is still unrelated to leukemia, discontinue this medicine until ANC ≥ 1 × 109/L and platelet count ≥ 20 × 109/L or higher, then resume treatment at a dose of 200mg/m2.

This drug should not be administered to patients who have had an allergic reaction to this drug or any of its components. Women who are pregnant or may become pregnant should not use this drug, as it may harm the fetus. Women who are breastfeeding should also avoid using this drug due to the risk of transferring the medication through breast milk to the baby. Caution should be exercised when administering this drug to patients with impaired liver function, and frequent monitoring of liver status is important. Patients with reduced kidney function should also be cautious when taking this drug, and kidney function should be monitored. Patients with heart disease or those at risk of heart failure should closely observe their heart condition while taking this drug. In patients with hypereosinophilia syndrome who have cardiac infiltration, the administration of this drug may result in cardiac shock or left ventricular dysfunction, necessitating treatment and monitoring by a specialist. Patients who take levothyroxine after thyroid surgery should have their thyroid hormone levels checked regularly, as hypothyroidism may occur. Long-term use of this drug in pediatric patients can lead to growth delays, so periodic monitoring of growth status is necessary. Tumor lysis syndrome may occur during the use of this drug, so it is recommended to improve dehydration status and control uric acid levels before administration. Patients who are hepatitis B virus carriers must be tested for viral infection before taking this drug and should consult with a specialist for regular monitoring to prevent reactivation of hepatitis during treatment. Common side effects of this drug include decreased blood cell counts, headache, dyspepsia, edema, weight gain, nausea, vomiting, muscle cramps, diarrhea, rash, fatigue, and abdominal pain, most of which are mild to moderate. If serious side effects occur, administration should be stopped and medical consultation should be sought immediately. This drug is used for various disease treatments, so careful dosage adjustment and monitoring according to the patient's condition are necessary.

Neutropenia, thrombocytopenia, anemia, headache, dyspepsia, edema, weight gain, nausea, vomiting, muscle cramps, musculoskeletal pain, diarrhea, rash, fatigue, abdominal pain, bone marrow suppression, gastrointestinal and tumor-related bleeding, hepatotoxicity, acute renal failure, hypophosphatemia, severe respiratory adverse reactions, tumor lysis syndrome, growth retardation in children, hypothyroidism, tumor lysis syndrome, reactivation of hepatitis B, cardiogenic shock, left ventricular dysfunction

This drug should be stored in a tightly closed container to prevent exposure to air and moisture. The recommended storage temperature is room temperature between 1 degree and 30 degrees Celsius. Storing it this way helps maintain the efficacy of the drug for a long time.

Appearance

Dark yellow to brown oblong film-coated tablet

Package unit

30 tablets (10 tablets/PTPX3)