Imabec 400 mg (Imatinib Mesylate)

Adult dosage

1. Chronic myeloid leukemia (CML), adults - Patients with Philadelphia chromosome-positive chronic-phase disease: 400mg once daily - Patients with accelerated-phase or blast-phase disease: 600mg once daily - In the absence of severe adverse reactions, the dose may be increased from 400mg to 600mg in patients with chronic-phase disease, and from 600mg to 800mg (400mg twice daily) in patients with accelerated-phase or blast-phase disease 2. Gastrointestinal stromal tumor (GIST), adults - Unresectable or metastatic disease: 400mg per day - Adjuvant therapy after resection: 400mg per day; a treatment duration of 3 years is recommended 3. Other conditions - Myelodysplastic syndromes/myeloproliferative diseases: 400mg per day - Hypereosinophilic syndrome/chronic eosinophilic leukemia: 100mg per day (may be increased up to 400mg) - Recurrent or metastatic dermatofibrosarcoma protuberans: 800mg per day (400mg twice daily) 4. Administration - Take with a meal and plenty of water - Take the 400mg or 600mg dose once daily - Take the 800mg dose as 400mg twice daily - For patients who have difficulty swallowing the film-coated tablets, suspend them in water or apple juice and take immediately 5. Dose adjustment - The dose may be reduced, and treatment may be interrupted and resumed, depending on adverse reactions or hematologic abnormalities - The minimum recommended dose for patients with hepatic or renal impairment is 400mg per day - No special dose adjustment is required for older patients

Children's dosage

Pediatric chronic myeloid leukemia - Patients with Philadelphia chromosome-positive chronic-phase, accelerated-phase, or blast-phase disease: 340mg/m2 per day based on body surface area (maximum total daily dose 600mg) - May be administered once daily or in 2 divided doses, in the morning and evening Administration - May be taken once daily or, optionally, the daily dose may be divided into 2 doses taken in the morning and evening Dose adjustment - If adverse reactions occur, reduce the dose based on body surface area (e.g., from 340mg/m2 to 260mg/m2 or 200mg/m2)

This medication should not be used in patients with hypersensitivity to this product or other components. Women who are pregnant or may become pregnant should not take this drug, and breastfeeding women should also avoid it. As this medication is used for specific hematological and oncological diseases such as chronic myeloid leukemia and gastrointestinal stromal tumors, careful administration is required based on the condition of these diseases. Patients with impaired liver or kidney function require special precautions during administration, and patients with a history of heart disease or heart failure must undergo regular monitoring. In the case of hypereosinophilia, administration of this medication may lead to cardiogenic shock or left ventricular dysfunction, so it is recommended to conduct cardiac function tests before administration and to consider steroid treatment if necessary. Hypothyroidism may occur, thus regular monitoring of thyroid function is necessary, and growth delay has been reported in pediatric patients before puberty, so growth status should be monitored closely. During administration of this medication, the possibility of tumor lysis syndrome should be considered, making it important to correct dehydration and manage uric acid levels. Patients who are carriers of hepatitis B virus must undergo infection testing before treatment with this medication and should closely monitor liver condition during and after treatment and consult a specialist if necessary. Side effects of this medication commonly include neutropenia, thrombocytopenia, anemia, dyspepsia, edema, nausea, muscle cramps, rash, and fatigue, and in severe cases, dose adjustments or discontinuation may be required. Therefore, it is crucial to conduct regular blood tests and clinical status checks following the doctor's instructions while taking this medication.

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

Store this medication in a tightly sealed container to protect it from air and moisture. Furthermore, it is important to keep it at room temperature between 15 to 30 degrees Celsius to maintain its effectiveness.

Appearance

Oval film-coated tablet, dark yellow to brown

Package unit

1 Box - 30 tablets/box [(10 tablets/PTP) X 3]