Rukibec Film-Coated Tablet 400 mg (Imatinib Mesylate)

Adult dose

1. Chronic myeloid leukemia (CML), adults - The recommended dose for patients in the chronic phase is 400mg once daily. - The recommended dose for patients in the accelerated or blast phase is 600mg once daily. - In the absence of severe adverse reactions or severe neutropenia or thrombocytopenia unrelated to leukemia, an increase from 400mg to 600mg in the chronic phase or from 600mg to 800mg (400mg twice daily) in the accelerated or blast phase may be considered. 2. Gastrointestinal stromal tumors (GIST), adults - The recommended dose is 400mg daily. - The recommended dose for adjuvant therapy is also 400mg daily. 3. Other diseases - Myelodysplastic/myeloproliferative diseases: 400mg daily is recommended. - Hypereosinophilic syndrome/chronic eosinophilic leukemia: 100mg daily is recommended; the dose may be increased to 400mg daily. - Recurrent or metastatic dermatofibrosarcoma protuberans: Take 800mg daily (400mg twice daily). 4. Administration - The 400mg or 600mg dose is taken once daily. - The 800mg dose is taken as 400mg twice daily. - Take with a meal and plenty of water. - If the film-coated tablets cannot be swallowed, suspend them in water or apple juice and take immediately. 5. Dose adjustment - For nonhematologic adverse reactions, interrupt treatment and reduce the dose or resume treatment according to symptoms. - For hematologic adverse reactions, dose reduction or interruption of treatment is recommended.

Child dose

1. Chronic myeloid leukemia (CML), pediatric patients - 340mg/m2 daily based on body surface area is recommended (the total daily dose must not exceed 600mg). - It may be administered once daily or in 2 divided doses, in the morning and evening. 2. Administration - It may be taken once daily or, optionally, as the daily dose divided into 2 doses in the morning and evening. 3. Dose adjustment - For nonhematologic adverse reactions, reduce the dose from 340mg/m2 to 260mg/m2, or from 260mg/m2 to 200mg/m2. - For hematologic adverse reactions, interrupt treatment, reduce the dose, and then resume treatment. - The dose based on body surface area may also be reduced for patients in the accelerated or blast phase (260mg/m2, 200mg/m2).

This medication should not be used in women who are allergic to this drug or other ingredients, who are pregnant or may become pregnant, and in women who are breastfeeding. Furthermore, caution should be exercised when administering this medication to patients with certain blood diseases or cancers such as chronic myeloid leukemia or gastrointestinal stromal tumors, as well as in patients with diminished liver or kidney function, or those with a history of heart disease or heart failure. In patients with hypereosinophilia who may have cardiac infiltration, there is a risk of cardiac dysfunction, so a cardiac ultrasound and blood tests should be conducted prior to administration to confirm the condition and steroid treatment may be added if necessary. Patients with thyroid dysfunction should have their thyroid-stimulating hormone levels regularly checked, and in pediatric patients, there have been reports of growth delay, so their growth should be closely monitored during treatment. Because there is a possibility of tumor lysis syndrome, it is important to correct dehydration and manage uric acid levels prior to administration. Additionally, patients who are carriers of the hepatitis B virus receiving this medication are at risk of hepatitis reactivation, so they should be tested for hepatitis B before and during treatment, and should consult with a specialist to closely monitor liver status during and after treatment. This medication may commonly cause a reduction in blood cell counts, indigestion, edema, skin rash, and fatigue among various side effects; serious side effects, including hepatotoxicity, renal failure, and severe respiratory adverse reactions, have also been reported infrequently. If side effects are severe, dose adjustments or discontinuation of treatment may be necessary, so immediate consultation with healthcare providers is recommended if any unusual symptoms occur.

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

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it is best to keep it at room temperature between 1°C and 30°C. Proper storage helps maintain the medication's effectiveness.

Appearance

Oval film-coated tablet, dark yellow to brown in color

Package unit

30 tablets (10 tablets/PTP × 3)