- Indications and Usage Flumatinib Mesylate Tablets are indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic phase.
- Dosage and Administration Recommended Dosage: The recommended dosage is 600 mg orally once daily until disease progression or intolerable toxicity. Administration: The tablets should be administered on an empty stomach (fasting for 2 hours before and 1 hour after administration). Swallow the tablet whole with water; do not chew or crush. Missed Dose: If a dose is missed, take it as soon as remembered unless it is close to the time of the next dose. Do not double the dose. Dose Modification: Dosage reductions (to 400 mg or 300 mg once daily) or temporary suspensions are required based on the severity of hematologic and non-hematologic adverse reactions, including specific protocols for febrile neutropenia and cardiac toxicity.
- Mechanism of Action Flumatinib is a tyrosine kinase inhibitor (TKI) that inhibits the Bcr-Abl kinase. It blocks the abnormal tyrosine kinase activity caused by the Bcr-Abl fusion gene, thereby inhibiting the proliferation of chronic myeloid leukemia cells.
- Safety and Warnings Hematologic Toxicity: Myelosuppression (thrombocytopenia, neutropenia, leukopenia, anemia) is very common and requires regular monitoring of complete blood counts. Cardiac Toxicity: Cardiac dysfunction may occur; ECG and cardiac function should be monitored, especially in patients with risk factors. Hepatic and Pancreatic Toxicity: Elevations in liver enzymes, bilirubin, and pancreatic enzymes (amylase/lipase) have been observed. Reproductive Toxicity: May cause fetal harm. Females of reproductive potential must use effective contraception during and for at least one month after the last dose.
- Adverse Reactions and Clinical Research The most common adverse reactions include thrombocytopenia, neutropenia, leukopenia, anemia, diarrhea, nausea, vomiting, and elevated liver enzymes. Serious adverse reactions may include severe myelosuppression, febrile neutropenia, cardiac dysfunction, and pancreatitis.
- Drug Interactions CYP3A4 Inhibitors: Strong CYP3A4 inhibitors may increase plasma concentrations of flumatinib. CYP3A4 Inducers: Concomitant use with strong CYP3A4 inducers may decrease plasma concentrations of flumatinib. Drugs Affecting Electrolytes: Use with caution due to the risk of electrolyte imbalances associated with diarrhea or vomiting.
- Pharmaceutical Information Composition: The active ingredient is flumatinib mesylate. Excipients include lactose monohydrate, microcrystalline cellulose, pregelatinized starch, and magnesium stearate. Appearance: Film-coated tablets, which appear white to pale yellow after removing the coating. Storage: Store at room temperature (below 30°C) in the original packaging.
Haosenxinfu Flumatinib Mesylate Tablets
Brand Name: 豪森昕福 ®（Haosenxinfu®）
Generic Name: Flumatinib Mesylate
Strength: 0.2 g (200 mg) per tablet, 30 tablets per box
Manufacturer: Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
Marketing Authorization Holder: Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
Approval Date in China: November 26, 2019
Registration Number:国药准字 H20190033
Storage: Seal tightly and store below 30°C, protect from light. Keep away from children. Refer to the full package insert for detailed storage specifications.
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