Glivec Film-Coated Tablet 300mg (Imatinib Mesylate)

Adult dose

Adults with chronic myeloid leukemia (CML) - Philadelphia chromosome-positive chronic phase: 400mg once daily - Philadelphia chromosome-positive accelerated phase or blast phase: 600mg once daily Adults with gastrointestinal stromal tumors (GIST): 400mg daily Myelodysplastic syndrome/myeloproliferative disease: 400mg daily Hypereosinophilic syndrome/chronic eosinophilic leukemia: 100mg daily; may be increased to a maximum of 400mg Recurrent or metastatic dermatofibrosarcoma protuberans: 800mg daily (take 400mg twice daily) High doses (600mg, 800mg) may be administered once daily or in 2 divided doses daily. Take with a meal and plenty of water. For patients unable to swallow film-coated tablets, suspend in water or apple juice and take immediately. Dose adjustment is necessary if severe adverse reactions or hematologic adverse reactions occur. For patients with hepatic or renal impairment, the minimum recommended dose is 400mg daily; the dose may be adjusted according to tolerability. Continue treatment until disease progression or unacceptable toxicity occurs.

Child dose

Pediatric chronic myeloid leukemia (CML) - Philadelphia chromosome-positive chronic phase, accelerated phase, or blast phase: 340mg/m2 per day based on body surface area (do not exceed a total daily dose of 600mg) - May be administered once daily or in 2 divided doses, in the morning and evening In pediatric patients, the dose may be reduced from 340mg/m2 to 260mg/m2 or 200mg/m2 when adjusting the dose If the film-coated tablets cannot be swallowed, suspend them in water or apple juice before taking Dose adjustment is required if severe adverse reactions or hematologic abnormalities occur

This medication should not be used in patients who are allergic to this drug or any of its components. Women who are pregnant or may become pregnant and nursing mothers should not take this medication. This drug should be administered with caution to patients with impaired liver function or weak kidney function. Patients with a history of heart disease or heart failure, and those with renal failure should be closely monitored by a physician during treatment with this drug. In particular, for patients with hypereosinophilia, there is a risk of serious cardiac side effects due to this medication, so a cardiac examination is recommended before administration. Patients with abnormal thyroid function, particularly those taking levothyroxine after thyroidectomy, should have regular thyroid function tests. In children before puberty, extended use of this drug may result in growth delays, hence growth status should be monitored consistently. Serious side effects such as tumor lysis syndrome may occur during medication use, therefore correcting dehydration and treating high uric acid levels is necessary. Patients who are carriers of the hepatitis B virus should undergo virus infection testing before taking this medicine and continuously monitor for activation of infection during treatment. Common side effects of this medication include decreased blood cell count, gastrointestinal symptoms, edema, muscle and joint pain, headaches, and fatigue, while some patients have reported severe side effects such as liver toxicity, acute renal failure, and serious respiratory adverse reactions. If side effects are severe, adjusting the dosage or discontinuing administration may be necessary, so consultation with healthcare providers is required.

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, ulceration, hepatotoxicity, acute renal failure, hypophosphatemia, severe respiratory adverse reactions, tumor lysis syndrome, growth retardation in children, hypothyroidism, delayed growth, cardiogenic shock, left ventricular dysfunction, reactivation of hepatitis B

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is safe to store at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain efficacy and prevent deterioration.

Appearance

A film-coated tablet that is dark yellow to brown and rectangular in shape.

Package unit

30 tablets (10 tablets/PTPX3)/carton