Glivec Film-Coated Tablets 100 mg (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 Philadelphia chromosome-positive accelerated-phase or blast-phase (blast crisis) chronic myeloid leukemia. 2. Gastrointestinal stromal tumor (GIST) - A dose of 400mg daily is recommended for adult patients with Kit (CD 117)-positive, unresectable and/or metastatic malignant gastrointestinal stromal tumor (GIST). - A dose of 400mg daily is recommended for adult patients receiving this drug as adjuvant therapy following resection of a Kit (CD 117)-positive gastrointestinal stromal tumor. 3. The following diseases associated with tyrosine kinases sensitive to imatinib - Myelodysplastic syndrome/myeloproliferative disease: A dose of 400mg daily is recommended. - Hypereosinophilic syndrome/chronic eosinophilic leukemia: A dose of 100mg daily is recommended and may be increased to 400mg daily. - Recurrent or metastatic dermatofibrosarcoma protuberans: 800mg daily (400mg twice daily) 4. How to take - 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. - Patients who cannot swallow the film-coated tablets may take them suspended in water or apple juice. 5. Dose escalation - In the absence of severe adverse reactions and cytopenia unrelated to severe leukemia, the dose may be increased from 400mg to 600mg in adult patients, and from 600mg to 800mg (400mg twice daily) in adult patients with accelerated- or blast-phase disease. 6. Dose adjustment - If nonhematologic adverse reactions occur, interrupt treatment until symptoms resolve, then resume treatment at a reduced dose. - If hematologic adverse reactions occur, dose reduction or interruption of treatment followed by resumption is recommended according to the severity of neutropenia and thrombocytopenia. 7. Duration of treatment - Continue treatment until disease progression or unacceptable toxicity occurs.

Child dose

1. Pediatric chronic myeloid leukemia (CML) - For patients with Philadelphia chromosome-positive chronic-, accelerated-, or blast-phase disease, a dose of 340mg/m2 of body surface area per day is recommended, not exceeding a total daily dose of 600mg. - The dose may be taken once daily or divided into 2 doses, in the morning and evening. 2. How to take - Children may take the dose once daily or, optionally, 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, dose reduction or interruption of treatment followed by resumption is recommended according to the severity of neutropenia and thrombocytopenia.

This drug should not be administered to patients with hypersensitivity to this medication or any of its ingredients. Women who are pregnant or likely to become pregnant should avoid using this medication as it may harm the fetus. Nursing mothers should also refrain from using this medication and may need to discontinue breastfeeding for safety. This drug is used in patients with specific conditions such as chronic myeloid leukemia and gastrointestinal stromal tumors, requiring careful administration depending on the patient's condition. Patients with impaired liver or kidney function may be affected by the metabolism and excretion of this medication, so careful monitoring is necessary. Patients with a history of heart disease or heart failure may experience worsening cardiac function when taking this medication and require regular cardiac evaluations. Severe cardiac adverse reactions may occur in patients with hypereosinophilia, making diagnosis and treatment by a cardiologist important. Hypothyroidism may develop, therefore thyroid function should be monitored regularly. In pediatric patients, growth retardation has been reported while on this medication, so their growth status should be consistently monitored. There's a risk of tumor lysis syndrome, so dehydration should be corrected and uric acid levels managed prior to administration. Individuals with chronic hepatitis B infection should be screened for viral infection before taking this medication, and if necessary, consult a specialist, while closely observing for virus reactivation during and after treatment. Common side effects when taking this medication include decreased blood cell counts, headache, dyspepsia, edema, weight gain, nausea, vomiting, muscle cramps, musculoskeletal pain, diarrhea, rash, fatigue, abdominal pain, among others. In case of severe side effects, dosage adjustment or discontinuation of the drug may be required, so immediate consultation with medical staff is essential in case of abnormal symptoms.

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

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. Additionally, to maintain the efficacy of the medication, it is important to store it at room temperature, specifically between 1 to 30 degrees Celsius.

Appearance

Dark yellow to brown round film-coated tablets

Package unit

60 tablets (10 tablets/PTPX6)/carton