Glivec 100mg (Imatinib Mesylate)

Adult dose

Chronic myeloid leukemia (CML), adults For adult patients with Philadelphia chromosome-positive chronic-phase chronic myeloid leukemia, a dose of 400mg once daily is recommended. For adult 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 following cases, if there are no severe adverse reactions or severe leukemia-unrelated neutropenia or thrombocytopenia, an increase from 400mg to 600mg may be considered for adult patients in the chronic phase, or an increase from 600mg to 800mg (400mg twice daily) may be considered for adult patients in the accelerated phase or blast phase (blast crisis). (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 Gastrointestinal stromal tumor (GIST) For adult patients with Kit (CD 117)-positive, unresectable and/or metastatic malignant gastrointestinal stromal tumor (GIST), a dose of 400mg daily is recommended. For adult patients receiving this drug as adjuvant therapy after resection of a Kit (CD 117)-positive gastrointestinal stromal tumor, a dose of 400mg daily 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. Diseases associated with tyrosine kinases sensitive to imatinib Myelodysplastic syndrome/myeloproliferative disease: A dose of 400mg daily is recommended. Hypereosinophilic syndrome/chronic eosinophilic leukemia: A dose of 100mg daily is recommended. The dose may be increased to 400mg daily. Recurrent or metastatic dermatofibrosarcoma protuberans: 800mg daily (400mg twice daily) Take the prescribed dose with a meal and a large glass 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. For patients unable to swallow film-coated tablets, the tablets may be suspended in water or apple juice. Place the required number of tablets in an appropriate amount of beverage and stir (approximately 50mL of liquid for a 100mg tablet). The suspension of fully disintegrated tablets should be taken immediately. Treatment should be continued 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. This drug is metabolized primarily in the liver, and the minimum recommended dose for patients with mild, moderate, or severe hepatic impairment is 400mg daily. The dose may be reduced if it is not tolerated. Renal excretion of this drug and its metabolites is minimal. The minimum recommended starting dose for patients with renal impairment or patients receiving hemodialysis is 400mg daily. However, caution is required when administering this drug to patients with renal impairment. If the drug is not tolerated, the dose may be reduced; if it is tolerated but efficacy is insufficient, the dose may be increased. No specific pharmacokinetic studies of this drug have been conducted in elderly patients; however, in approximately 20% of clinical trial participants who were 65 years of age or older, there were no significant age-related pharmacokinetic differences. There is no specific recommended dose for elderly patients. In the event of nonhematologic adverse reactions If a severe nonhematologic adverse reaction occurs with use of this drug, interrupt treatment until the symptoms resolve. Then resume treatment as appropriate according to the initial severity of the adverse reaction. If the bilirubin level rises to more than 3 times the upper limit of normal (IULN: Institutional Upper Limit of Normal) or liver transaminases rise to more than 5 times the upper limit of normal (IULN), treatment should be interrupted until the bilirubin level is 1.5 times or less the upper limit of normal (IULN) and transaminases are less than 2.5 times the upper limit of normal (IULN). Treatment may then be continued at a reduced daily dose. The adult dose should be reduced from 400mg to 300mg, from 600mg to 400mg, or from 800mg to 600mg. In the event of hematologic adverse reactions Dose reduction or treatment interruption is recommended for severe neutropenia and thrombocytopenia as follows. Hypereosinophilic syndrome and chronic eosinophilic leukemia (initial 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/myelodysplasia, gastrointestinal stromal tumor (initial 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 platelet count ≥ 75 × 109/L. Resume treatment with this drug at the original initial dose of 400mg. If ANC < 1.0 × 109/L and/or 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 (initial 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 this drug until ANC ≥ 1 × 109/L and platelet count ≥ 20 × 109/L, then resume treatment at a dose of 300mg. Dermatofibrosarcoma protuberans (initial 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 falls again to < 50 × 109/L, repeat step 1 and resume treatment at the reduced dose of 400mg. ANC = absolute neutrophil count Occurrence after at least 1 month of treatment

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 based on body surface area is recommended (the total daily dose should not exceed 600mg). It may be administered once daily or divided into 2 doses, in the morning and evening. In pediatric patients, this medicine may be taken once daily or, optionally, with the daily dose divided into 2 doses, in the morning and evening. The pediatric dose should be 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 severe adverse reaction occurred). If ANC < 1.0 × 109/L and/or platelet count falls again to < 50 × 109/L, 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 treatment with this medicine until ANC ≥ 1 × 109/L and platelet count ≥ 20 × 109/L, then resume treatment at a dose of 200mg/m2.

This drug should not be administered to patients with known allergies to this drug or other ingredients. It is advisable not to use this drug in pregnant women or women who may become pregnant. Nursing mothers are also advised against using this drug. Special caution is needed when prescribing this drug to patients with impaired liver or kidney function. Patients with a history of heart disease, heart failure, or kidney failure require close monitoring by a physician while taking this drug. In particular, patients with hypereosinophilia syndrome may experience cardiac effects, so cardiac function tests are recommended. Patients taking levothyroxine after thyroid surgery should regularly check their thyroid function. Long-term use of this drug in pediatric patients may cause growth delay, thus growth should be closely monitored. It is advisable to correct dehydration and treat elevated uric acid levels prior to starting this drug. Hepatitis B virus carriers should consult a specialist and have regular check-ups to prevent hepatitis activation before and during treatment with this drug. Common side effects include blood abnormalities such as neutropenia, thrombocytopenia, anemia, and other symptoms like headache, dyspepsia, edema, nausea, vomiting, muscle cramps, diarrhea, rash, and fatigue. Rare adverse reactions have also been reported, such as hepatotoxicity, acute renal failure, hypophosphatemia, severe respiratory adverse reactions, and tumor lysis syndrome, so patients should immediately consult healthcare providers if any unusual symptoms arise. Dose adjustments or discontinuation may be necessary depending on the severity of side effects during treatment with this drug. Therefore, it is important to take this drug carefully according to a physician’s instructions and to have regular check-ups.

• Neutropenia
• thrombocytopenia
• anemia
• headache
• dyspepsia
• edema
• weight gain
• nausea
• vomiting
• muscle cramps

This drug is sensitive to air and moisture, so it must be stored in a sealed container. It is best to store it at room temperature between 1 and 30 degrees Celsius.

Appearance

Dark yellow-brown round film-coated tablet

Package unit

60 tablets/PTP