Leukobec Tablet 400 Milligrams (Imatinib Mesylate)

Adult dose

1. Chronic Myeloid Leukemia (CML) - 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 accelerated-phase or blast-phase chronic myeloid leukemia. - If no severe adverse reactions occur, dose escalation may be considered from 400mg to 600mg in adults with chronic-phase disease, and from 600mg to 800mg (400mg twice daily) in adults with accelerated-phase or blast-phase disease. 2. Gastrointestinal Stromal Tumor (GIST) - A dose of 400mg once daily is recommended for adults with Kit (CD 117)-positive, unresectable and/or metastatic malignant gastrointestinal stromal tumors. - A dose of 400mg once daily is recommended as adjuvant therapy after surgical resection, with a recommended treatment duration of 3 years. 3. Other Imatinib-Sensitive Diseases - Myelodysplastic syndromes/Myeloproliferative diseases: 400mg once daily - Hypereosinophilic syndrome/Chronic eosinophilic leukemia: 100mg once daily (may be increased up to a maximum of 400mg) - Recurrent or metastatic dermatofibrosarcoma protuberans: 800mg once daily (400mg twice daily) 4. How to Take - Take 400mg or 600mg once daily; take 800mg as 400mg twice daily. - Take with food and plenty of water. - If you cannot swallow the film-coated tablet, disperse it in water or apple juice and take immediately. - Continue treatment in cases of disease progression or unacceptable toxicity. 5. Dose Adjustment - If adverse reactions occur, interrupt treatment and resume it with dose adjustment according to symptoms. - For patients with hepatic or renal impairment, a minimum dose of 400mg once daily is recommended; the dose may be adjusted according to tolerability. - No separate recommended dose for elderly patients.

Child dose

1. Pediatric chronic myeloid leukemia (CML) - For pediatric patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic, accelerated, and blast phases, a dose of 340mg/m2 per day based on body surface area is recommended (not exceeding a total daily dose of 600mg) - May be administered once daily or in 2 divided doses, in the morning and evening 2. How to take - May be taken once daily or, optionally, in 2 divided doses per day 3. Dose adjustment - If nonhematologic or hematologic adverse reactions occur, treatment interruption and dose reduction are recommended - Reduce the dose from 340mg/m2 to 260mg/m2, or from 260mg/m2 to 200mg/m2 - In pediatric patients with chronic myeloid leukemia in the accelerated or blast phase, the starting dose of 340mg/m2 may be reduced to 260mg/m2 or 200mg/m2 depending on adverse reactions

This medication should not be used by individuals with allergic reactions to this drug or any of its constituents. Women who are pregnant or may become pregnant should not take this medication, and those who are breastfeeding should also avoid using it. Patients with impaired liver or kidney function should use this drug with caution, and those with a history of heart disease or congestive heart failure should be closely monitored by a physician. Individuals with hypereosinophilia syndrome, in particular, may experience heart function abnormalities after taking this medication, making cardiologist evaluation and treatment important. Patients who have undergone thyroid surgery should carefully monitor thyroid function to check for any changes while taking this medication. For children, prolonged use of this medication may lead to growth delays, so their growth status should be checked regularly. Serious side effects such as tumor lysis syndrome can occur while taking this medication, so it is recommended to improve dehydration prior and treat elevated uric acid levels. Individuals who are carriers of the hepatitis B virus must undergo testing before receiving this medication and should monitor closely for potential hepatitis recurrence during treatment. Common side effects experienced while taking this medication include decreased white blood cell and platelet counts, anemia, headache, dyspepsia, edema, weight gain, nausea, vomiting, muscle cramps, musculoskeletal pain, diarrhea, rash, fatigue, and abdominal pain. Adjustments to the drug dosage may be necessary depending on the severity of side effects, and if serious side effects occur, the medication should be discontinued and a physician consulted. This medication is used for treating various blood cancers and gastrointestinal stromal tumors; however, health conditions must be thoroughly checked before and during treatment.

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-associated hemorrhage, bowel obstruction, perforation, ulceration, hepatotoxicity, acute renal failure, hypophosphatemia, severe respiratory adverse reactions, tumor lysis syndrome, growth retardation in children, hypothyroidism, growth delay, cardiogenic shock, left ventricular dysfunction, reactivation of hepatitis B

This medication should be stored in a tightly sealed container to avoid contact with air or moisture. It is important to maintain storage temperatures between 1 to 30 degrees Celsius. Proper storage will help retain the medication's effectiveness and safety over time.

Appearance

Dark yellow to brown film-coated tablet with a rectangular shape

Package unit

30 tablets (10 tablets/PTP*3)