Carevec Tablet 100 mg (Imatinib Mesylate)

Adult dose

1. Chronic myeloid leukemia (CML), adults - Chronic phase: 400mg once daily - Accelerated phase or blast phase: 600mg once daily 2. Gastrointestinal stromal tumor (GIST), adults - 400mg daily 3. Other diseases - Myelodysplastic syndromes/myeloproliferative diseases: 400mg daily - Hypereosinophilic syndrome/chronic eosinophilic leukemia: 100mg daily (may be increased up to 400mg) - Recurrent or metastatic dermatofibrosarcoma protuberans: 800mg daily (400mg per dose, 2 times daily) 4. Administration - Take 400mg or 600mg once daily - Take 800mg as 400mg 2 times daily - Take with a meal and plenty of water 5. Dose adjustment - In the event of severe adverse reactions, treatment may be interrupted and resumed with dose adjustment according to symptoms - 400mg daily is recommended for patients with hepatic or renal impairment - No special dose recommendation for elderly patients

Child dose

1. Chronic myeloid leukemia (CML), children - 340mg/m2 per body surface area per day (do not exceed a total daily dose of 600mg) - May be administered once daily or in 2 divided doses, morning and evening 2. Administration - May be taken once daily or as the daily dose divided into 2 doses, morning and evening 3. Dose adjustment - Dose may be reduced in the event of severe adverse reactions (reduce from 340mg/m2 to 260mg/m2 or 200mg/m2)

This medication should not be used in patients who are allergic to this drug or other components. It is safe for women who are pregnant or may become pregnant to avoid taking this medication. Women who are breastfeeding should also refrain from taking this medication. This drug has clinical trial results for specific diseases such as certain blood cancers or gastrointestinal stromal tumors, but caution should be exercised when used in patients with impaired liver or kidney function. Patients with a history of heart disease, heart failure, or kidney failure should closely monitor symptoms or signs while taking this medication and receive appropriate treatment if necessary. For patients with hypereosinophilia who may have heart issues, cardiac function tests may be required prior to administration, and steroid therapy may be administered if necessary. Hypothyroidism may occur, so regular thyroid function tests should be conducted. In pediatric patients prior to puberty, growth retardation has been reported, therefore growth status should be continuously monitored in children. Patients taking this medication are at risk of tumor lysis syndrome, making it advisable to correct dehydration and treat hyperuricemia before administration. Hepatitis B virus carriers should undergo blood tests before taking this medication and closely monitor for hepatitis reactivation during and after treatment. Common side effects when taking this drug include decreases in blood cell counts, headaches, dyspepsia, edema, weight gain, nausea, vomiting, muscle cramps, pain, diarrhea, rash, fatigue, and abdominal pain. Depending on the severity of side effects, dosage adjustment or discontinuation of therapy may be necessary. Additionally, serious side effects such as liver toxicity, acute renal failure, hypophosphatemia, severe respiratory adverse reactions, tumor lysis syndrome, or growth retardation in children have been rarely reported, thus immediate consultation with a doctor is warranted upon the appearance of any abnormal symptoms.

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

This medication is sensitive to air and moisture, so it should be kept in a tightly sealed container. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius to preserve the effectiveness of the medication.

Appearance

Dark yellow to brown round film-coated tablet

Package unit

60 tablets (10 tablets/PTP x 6)