Gleevec Film-Coated Tablets 400 mg (Imatinib Mesylate)

Adult dose

Chronic myeloid leukemia (CML), adults: For patients with Philadelphia chromosome-positive chronic-phase chronic myeloid leukemia, a dose of 400mg once daily is recommended. For patients with Philadelphia chromosome-positive accelerated-phase or blast-phase (blast crisis) chronic myeloid leukemia, a dose of 600mg once daily is recommended. In the absence of severe adverse reactions and severe neutropenia or thrombocytopenia unrelated to leukemia, an increase from 400mg to 600mg in adult patients in the chronic phase, or from 600mg to 800mg (administered as 400mg twice daily) in adult patients in the accelerated phase or blast phase (blast crisis), may be considered in cases of disease progression (at any time), failure to achieve a satisfactory hematologic response after at least 3 months of treatment, failure to achieve a cytogenetic response after 6-12 months of treatment, or loss of a previously achieved hematologic or cytogenetic response. Gastrointestinal stromal tumors (GIST): For adults with unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST) that are Kit (CD 117)-positive, a dose of 400mg per day is recommended. For adults receiving this drug as adjuvant therapy after resection of Kit (CD 117)-positive gastrointestinal stromal tumors, a dose of 400mg per day is recommended. The optimal duration of administration of this drug as adjuvant therapy has not been established. A clinical trial comparing administration of this drug for 1 year and 3 years in patients at high risk of GIST recurrence recommended a treatment duration of 3 years. Myelodysplastic syndromes/myeloproliferative diseases: A dose of 400mg per day is recommended. Hypereosinophilic syndrome/chronic eosinophilic leukemia: A dose of 100mg per day is recommended. The dose may be increased to 400mg per day. Recurrent or metastatic dermatofibrosarcoma protuberans: 800mg per day (400mg per dose twice daily) Take the prescribed dose with a meal and plenty of water to minimize the risk of gastrointestinal irritation. A dose of 400mg or 600mg is taken once daily, and an 800mg dose is taken as 400mg twice daily. Treatment should continue until there is evidence of disease progression or unacceptable toxicity. Because the incidence of adverse reactions may increase at higher doses, patients whose dose is increased should be monitored closely. The minimum recommended dose for patients with mild, moderate, or severe hepatic impairment is 400mg per day. The dose may be reduced if it is not tolerated. The minimum recommended starting dose for patients with renal impairment or patients receiving hemodialysis is 400mg per day. However, caution is required when administering this drug to patients with renal impairment. If the dose is not tolerated, it may be reduced; if it is tolerated but efficacy is inadequate, the dose may be increased. 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. If a severe nonhematologic adverse reaction occurs, interrupt treatment until the symptoms resolve. Then resume treatment as appropriate according to the initial severity of the adverse reaction. If bilirubin levels rise to more than 3 times the institutional upper limit of normal (IULN), or liver transaminases rise to more than 5 times the institutional upper limit of normal (IULN), treatment should be interrupted until bilirubin levels are at or below 1.5 times the institutional upper limit of normal (IULN) and transaminases are below 2.5 times the institutional upper limit of normal (IULN). Treatment may then continue at a reduced daily dose. The adult dose is reduced from 400mg to 300mg, 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 the 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 syndromes/myeloproliferative disorders, gastrointestinal stromal tumors (starting dose 400mg); 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 the 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 the platelet count falls again 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 it further to 300mg. If the cytopenia persists for 4 weeks and is still not related to leukemia, interrupt this drug until ANC ≥ 1 × 109/L and the 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 the platelet count ≥ 75 × 109/L. Resume treatment with this drug at 600mg. If ANC < 1.0 × 109/L and/or the platelet count falls again to < 50 × 109/L, repeat step 1 and resume treatment at the reduced dose of 400mg.

Child dose

For patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic, accelerated, or blast phase, a dose of 340mg/m2 per day is recommended (total daily dose not exceeding 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, in 2 divided doses in the morning and evening. Reduce the pediatric dose 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 original previous dose (before the severe adverse reaction occurred). If ANC < 1.0 × 109/L and/or platelet count < 50 × 109/L recurs, 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, further reduce the dose to 200mg/m2. If the cytopenia persists for 4 weeks and is still unrelated to leukemia, interrupt this medicine until ANC ≥ 1 × 109/L and platelet count ≥ 20 × 109/L, and then resume treatment at a dose of 200mg/m2. Occurring after at least 1 month of treatment

This medication should not be used in individuals with allergic reactions to this drug or other components, or in pregnant women or those who may become pregnant. Additionally, breastfeeding women should not take this medication. Patients with specific blood cancers or gastrointestinal stromal tumors should be administered this medication with caution, and careful attention is required for patients with impaired liver or kidney function. Patients with a history of heart disease, heart failure, or renal failure should monitor their heart condition closely, and immediate treatment should be initiated if abnormal symptoms appear. Some patients with hypereosinophilia syndrome might experience cardiac issues after taking this medication; hence, cardiac function tests are recommended, and steroid treatment should be considered if necessary. As this medication may affect thyroid function, patients taking levothyroxine after thyroid surgery should have their Thyroid Stimulating Hormone levels checked regularly. In pediatric patients, there have been reports of growth delay, hence continuous monitoring of growth is necessary. Serious side effects known as tumor lysis syndrome can occur with this medication; therefore, dehydration should be corrected, and appropriate treatment is needed if uric acid levels are high before treatment. Patients who are carriers of the hepatitis B virus must undergo viral testing before taking this medication, and liver function should be closely monitored during and after treatment. Common side effects while taking this medication may include neutropenia, thrombocytopenia, anemia, headache, dyspepsia, edema, weight gain, nausea, vomiting, muscle cramps, diarrhea, rash, fatigue, and abdominal pain. If side effects are severe, dose adjustment or cessation of administration may be necessary, and immediate consultation with healthcare professionals is advised if abnormal symptoms occur.

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, gastrointestinal obstruction, perforation, ulcers, hepatotoxicity, acute kidney failure, hypophosphatemia, severe respiratory adverse reactions, tumor lysis syndrome, growth delays in children, hypothyroidism, growth retardation, cardiogenic shock, left ventricular dysfunction, reactivation of hepatitis B

This medication may be sensitive to air or moisture; therefore, it must be stored in a tightly closed container. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius (room temperature). Proper storage preserves the medication's efficacy and safety for a longer duration.

Appearance

Dark yellow to brown oblong film-coated tablet

Package unit

30 tablets (10 tablets/PTPX3)/carton