JT-Nib 100 mg (Imatinib Mesylate)

Adult dosage

Chronic myeloid leukemia (CML) in adults: A dose of 400mg once daily is recommended for adult 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. In the following cases, if there are no severe adverse reactions or severe leukemia-unrelated neutropenia or thrombocytopenia, an increase from 400mg to 600mg in adult patients with chronic-phase disease, or from 600mg to 800mg (400mg twice daily) in adult patients with accelerated-phase or blast-phase (blast crisis) disease, may be considered. (1) Disease progression (at any time) (2) Failure to achieve a satisfactory hematologic response after at least 3 months of treatment (3) Failure to achieve a cytogenetic response after 6-12 months of treatment (4) Loss of a previously achieved hematologic or cytogenetic response Gastrointestinal stromal tumors (GIST): A dose of 400mg once daily is recommended for adults with Kit (CD 117)-positive, unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). A dose of 400mg once daily is recommended for adults receiving this drug as adjuvant therapy after resection of Kit (CD 117)-positive gastrointestinal stromal tumors. The optimal duration of administration of this drug as adjuvant therapy has not been established. In a clinical trial comparing administration of this drug for 1 year and 3 years in patients at high risk of GIST recurrence, a treatment duration of 3 years was recommended. Diseases associated with tyrosine kinases sensitive to imatinib: Myelodysplastic syndromes/myeloproliferative diseases: A dose of 400mg once daily is recommended. Hypereosinophilic syndrome/chronic eosinophilic leukemia: A dose of 100mg once daily is recommended. The dose may be increased up to 400mg once daily. Recurrent or metastatic dermatofibrosarcoma protuberans: 800mg daily (400mg twice daily) The prescribed dose should be taken with a meal and plenty of water to minimize the risk of gastrointestinal irritation. The 400mg or 600mg dose is taken once daily, and the 800mg dose is taken as 400mg twice daily. For patients unable to swallow film-coated tablets, the tablets may be suspended in water or apple juice. Add the required number of tablets to an appropriate amount of liquid and stir (approximately 50mL of liquid for a 100mg tablet). The suspension of completely disintegrated tablets should be taken immediately. Treatment should continue until there is evidence of disease progression or unacceptable toxicity. Patients whose dose is increased should be closely monitored because the incidence of adverse reactions may increase at higher doses. This drug is primarily metabolized in the liver, and the minimum recommended dose for patients with mild, moderate, or severe hepatic impairment is 400mg once daily. The dose may be reduced if the patient cannot tolerate it. Classification of hepatic impairment Mild: Total bilirubin: = 1.5 ULN; AST: > ULN (may be normal or lower than ULN if total bilirubin is higher than ULN) Moderate: Total bilirubin: > 1.5-3.0 ULN; AST: Not applicable Severe: Total bilirubin: > 3-10 ULN; AST: Not applicable ULN: Upper limit of normal AST: Aspartate aminotransferase Renal excretion of this drug and its metabolites is minimal. The minimum recommended starting dose for patients with renal impairment or patients receiving hemodialysis is 400mg once daily. However, caution is required when administering this drug to patients with renal impairment. If the patient cannot tolerate it, the dose may be reduced; if the patient tolerates it but efficacy is insufficient, the dose may be increased. No specific pharmacokinetic studies of this drug have been conducted in elderly patients; however, no significant age-related pharmacokinetic differences were observed in approximately 20% of patients aged 65 years or older who participated in clinical trials. There is no specific recommended dose for elderly patients. In the event of nonhematologic adverse reactions: If a severe nonhematologic adverse reaction occurs with use of this drug, interrupt treatment until the symptoms resolve. Thereafter, treatment may be resumed as appropriate according to the initial severity of the adverse reaction. If bilirubin levels rise to more than 3 times the upper limit of normal (IULN: Institutional Upper Limit of Normal) or hepatic transaminases rise to more than 5 times the upper limit of normal (IULN), treatment should be interrupted until bilirubin levels are 1.5 times or less the upper limit of normal (IULN) and transaminases are less than 2.5 times the upper limit of normal (IULN). Treatment may then be continued at a reduced daily dose. The adult dose should be reduced from 400mg to 300mg, or from 600mg to 400mg, or from 800mg to 600mg, In the event of hematologic adverse reactions: Dose reduction or interruption of treatment for severe neutropenia and thrombocytopenia is recommended as shown in the table below. Hypereosinophilic syndrome and chronic eosinophilic leukemia (initial dose 100mg): ANC < 1.0 × 109/L and/or platelets < 50 × 109/L. 1. Interrupt treatment with this drug until ANC ≥ 1.5 × 109/L and platelet count ≥ 75 × 109/L. 2. Resume treatment with this drug at the previous dose (the dose before the severe adverse reaction occurred). Chronic-phase chronic myeloid leukemia, myelodysplastic syndromes/myelodysplastic proliferative disorders, gastrointestinal stromal tumors (initial dose 400mg); hypereosinophilic syndrome/chronic eosinophilic leukemia (dose 400mg): ANC < 1.0 × 109/L and/or platelets < 50 × 109/L. 1. Interrupt treatment with this drug until ANC ≥ 1.5 × 109/L and platelet count ≥ 75 × 109/L. 2. Resume treatment with this drug at the original initial dose of 400mg. 3. If ANC falls again to < 1.0 × 109/L and/or platelet count falls again to < 50 × 109/L, repeat step 1 and resume treatment at the reduced dose of 300mg. Accelerated-phase or blast-phase chronic myeloid leukemia (initial dose 600mg): ANC < 0.5 × 109/L and/or platelets < 10 × 109/L. 1. Determine whether the cytopenia is related to leukemia (bone marrow aspiration or biopsy). 2. If the cytopenia is not related to leukemia, reduce the dose of this drug to 400mg. 3. If the cytopenia persists for 2 weeks, reduce the dose further to 300mg. 4. If the cytopenia persists for 4 weeks and is still not related to leukemia, interrupt this drug until ANC ≥ 1 × 109/L and platelet count ≥ 20 × 109/L, and then resume treatment at a dose of 300mg. Dermatofibrosarcoma protuberans (initial dose 800mg): ANC < 1.0 × 109/L and/or platelets < 50 × 109/L. 1. Interrupt treatment with this drug until ANC ≥ 1.5 × 109/L and platelet count ≥ 75 × 109/L. 2. Resume treatment with this drug at 600mg. 3. If ANC falls again to < 1.0 × 109/L and/or platelet count falls again to < 50 × 109/L, repeat step 1 and resume treatment at the reduced dose of 400mg. ANC = absolute neutrophil count Occurrence after at least 1 month of treatment

Children's dosage

For patients with chronic myeloid leukemia in the chronic, accelerated, or blast phase who are Philadelphia chromosome-positive, a dose of 340mg/m2 per day based on body surface area is recommended (the total daily dose must not exceed 600mg). The dose may be administered once daily or divided into 2 doses per day, in the morning and evening. Pediatric patients may take this medicine once daily or, optionally, divide the daily dose into 2 doses, in the morning and evening. Reduce the pediatric dose from 340mg/m2 to 260mg/m2, or from 260mg/m2 to 200mg/m2. Pediatric chronic-phase chronic myeloid leukemia (starting dose 340mg/m2): ANC < 1.0 × 109/L and/or platelets < 50 × 109/L. 1. Interrupt treatment with this medicine until ANC ≥ 1.5 × 109/L and platelet count ≥ 75 × 109/L. 2. Resume treatment at the original previous dose (before the severe adverse reaction occurred). 3. If ANC < 1.0 × 109/L and/or platelet count < 50 × 109/L recurs, repeat step 1 and resume treatment at the reduced dose of 260mg/m2. Pediatric accelerated-phase or blast-phase chronic myeloid leukemia (starting dose 340mg/m2): ANC < 0.5 × 109/L and/or platelets < 10 × 109/L. 1. Determine whether the cytopenia is related to leukemia (bone marrow aspiration or biopsy). 2. If the cytopenia is not related to leukemia, reduce the dose of this medicine to 260mg/m2. 3. If the cytopenia persists for 2 weeks, further reduce the dose to 200mg/m2. 4. If the cytopenia persists for 4 weeks and is still not related to leukemia, interrupt this medicine until ANC ≥ 1 × 109/L and platelet count ≥ 20 × 109/L, and then resume treatment at a dose of 200mg/m2.

This medication should not be used in patients with allergies to specific ingredients, pregnant women or those who may become pregnant, and breastfeeding women. Additionally, caution should be exercised when used in patients with poor liver or kidney function, or those at risk of heart disease or with a history of heart failure or renal failure. These patients should be closely monitored during treatment. For patients with hypereosinophilia who may have heart issues, it is recommended to check heart conditions through echocardiography and blood tests before administering this medication, and to consider steroid treatment if necessary. Regular thyroid function tests are needed as hypothyroidism may occur, and patients who have undergone thyroidectomy require additional caution. In pediatric patients before puberty, there have been reports of growth delays, so growth status should be continuously monitored. During treatment with this drug, it is important to prevent dehydration and, if uric acid levels are high, to provide appropriate treatment to reduce the risk of tumor lysis syndrome. Patients with chronic hepatitis B must consult with specialists before and during treatment with this medication, and liver function abnormalities or reactivation of hepatitis B should be regularly tested. Common side effects include reductions in blood cell counts, digestive disorders, edema, muscle pain, rashes, and fatigue, while serious adverse reactions such as hepatotoxicity or acute renal failure may also occur infrequently. Depending on the severity of adverse reactions, drug dosage adjustment may be necessary, and in severe cases, treatment may need to be discontinued. Therefore, regular blood tests and physical examinations are essential to monitor for adverse reactions 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-related bleeding, gastrointestinal obstruction, perforation, ulceration, hepatotoxicity, acute renal failure, hypophosphatemia, severe respiratory adverse reactions, tumor lysis syndrome, growth delay in children, hypothyroidism, growth delay, cardiogenic shock, left ventricular dysfunction, reactivation of hepatitis B

This medication is sensitive to air and moisture, so it must be stored in a tightly closed container. It is important to maintain a storage temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the efficacy and safety of the medication over time.

Appearance

Dark yellow to brown round film-coated tablets

Package unit

60 tablets (10/PTPX6)