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Imatinib Mesylate Tablets

Functions and indications:
Imatinib mesylate tablets/imatinib mesylate capsules: 1. For the treatment of chronic phase, accelerated phase or blast phase of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML). 2. For the treatment of adult patients with unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). 3. Combined with chemotherapy for the treatment of newly diagnosed pediatric patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL). 4. For the treatment of adult patients with relapsed and refractory Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL). 5. The safety and efficacy information for the following indications mainly comes from foreign research data, and the data for Chinese population is limited: (1) For the treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) with FIP1L1-PDGFRα fusion kinase. (2) For the treatment of adult patients with myelodysplastic syndrome/myeloproliferative disease (MDS/MPD) with platelet-derived growth factor receptor (PDGFR) gene rearrangement. (3) For the treatment of adult patients with aggressive systemic mastocytosis (ASM) without D816Vc-Kit gene mutation or unknown c-Kit gene mutation. (4) For the treatment of unresectable, recurrent or metastatic dermatofibrosarcoma protuberans (DFSP). (5) For adjuvant treatment of adult patients with a significant risk of recurrence after surgical resection of Kit (CD117)-positive GIST. Patients with very low and low risk of recurrence should not receive this adjuvant treatment.

Dosage and Administration:
Imatinib mesylate tablets: 1. Treatment should be performed by a physician with experience in treating patients with malignant tumors. Imatinib mesylate should be taken with meals and a large glass of water to minimize the risk of gastrointestinal disturbances. Usually, adults take 400mg or 600mg once a day, and the daily dose is 800mg, that is, 400mg twice a day (in the morning and evening). Children and adolescents take it once or twice a day (in the morning and evening). Patients (including children) who cannot swallow tablets can disperse the tablets in water or apple juice without gas (about 50ml for 100mg tablets and about 200ml for 400mg). The suspension should be stirred and taken immediately once the tablet is completely disintegrated. As long as the patient continues to benefit, this product treatment should continue. 2. The dosage adjustment for special patients is detailed in the instructions. Imatinib mesylate capsules: 1. Treatment should be carried out by physicians who have experience in treating patients with malignant tumors. 2. Imatinib mesylate should be taken with meals and a large glass of water should be drunk to minimize the risk of gastrointestinal disorders. 3. Usually, adults take 400mg or 600mg once a day, and the daily dose is 800mg, that is, 400mg twice a day (in the morning and evening). Children and adolescents take once or twice daily (morning and evening). 4. Patients (including children) who cannot swallow capsules can disperse the drug in the capsules in water or apple juice. It is recommended that pregnant and lactating women avoid contact with the skin or eyes, or inhalation when opening the capsules (see [Pregnant and lactating women use]), and wash hands immediately after touching the opened capsules. 5. As long as the patient continues to benefit, this product treatment should continue. 6. For special patients, please refer to the instructions for dosage adjustments.

Adverse reactions:
Imatinib mesylate tablets/imatinib mesylate capsules: The overall safety characteristics of imatinib in human clinical use are summarized and described through more than 12 years of experience with imatinib. In clinical development, most patients will experience adverse events at some point in treatment. The most commonly reported adverse events (>10%) are neutropenia, thrombocytopenia, anemia, headache, dyspepsia, edema, weight gain, nausea, vomiting, muscle cramps, musculoskeletal pain, diarrhea, rash, fatigue and abdominal pain. The severity of these events was mild to moderate, and only 2% to 5% of patients had permanent discontinuation of treatment due to drug-related adverse events. The safety difference between patients with Ph+ leukemia and solid tumors was that the incidence and severity of myelosuppression in patients with Ph+ leukemia and gastrointestinal (GI) adverse events and intratumoral hemorrhage in patients with GIST were higher and were likely due to disease-related factors. Myelosuppression, GI adverse events, edema, and rash were common in both patient groups. Other GI conditions, such as gastrointestinal obstruction, perforation, and ulceration, appear to be mostly indication-specific adverse reactions. Other prominent adverse events observed after exposure to imatinib and possibly causally related to the use of this product include hepatotoxicity, acute renal failure, hypophosphatemia, severe respiratory adverse reactions, tumor lysis syndrome, and developmental delay in children. Depending on the severity of these adverse events, dose adjustment may be required. For details on adverse reactions, please refer to the drug instructions.

Contraindications:
Imatinib mesylate tablets/imatinib mesylate capsules: Patients who are allergic to the active substance or any excipient ingredients of this drug are contraindicated.

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