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Has Gilteritinib been launched in China? What are the precautions for medication?
Publisher:海鸥医学顾问     Publication Date:2025-09-24 17:50      The article comes from the Internet

Gilteritinib, as an FLT3 inhibitor, has significant efficacy in patients with relapsed/refractory acute myeloid leukemia (AML) carrying FLT3 mutations, but strict adherence to medication precautions is necessary to ensure safety and efficacy. At present, it has not been officially listed in Chinese Mainland, and patients need to purchase drugs through overseas channels, but they need to be alert to drug quality risks and follow the doctor's instructions.

1. Domestic listing status

(1) According to drug regulatory information, Jiretinib has not yet been approved for marketing by the China National Medical Products Administration, and there is currently no sale in domestic hospitals and regular pharmacies.

2. Suggestions for obtaining channels

(1) Overseas drug purchase: It can be purchased through pharmacies in Hong Kong, Macau, and other regions with legitimate prescriptions, and complete medical records and doctor's prescriptions must be provided.

(2) Clinical trials: Pay attention to FLT3 inhibitor related clinical trials conducted in domestic hospitals, which may provide opportunities for medication.

3 Medication precautions

(1) Quality verification: When purchasing, it is necessary to verify the drug batch number, production date, and original packaging. It is recommended to seek assistance from a professional cross-border medical platform.

(2) Dose adjustment: This drug needs to be used based on FLT3 mutation test results. Before purchasing overseas drugs, genetic testing must be completed and hematology experts consulted.

4 therapeutic effects

(1) Clinical studies have shown that Girotinib achieves complete remission in approximately 21% of FLT3-ITD or FLT3-TKD mutant AML patients, with a median remission duration of 4.8 months.

(2) This drug can significantly prolong progression free survival (PFS) and reduce the risk of disease progression or death by 54% compared to traditional chemotherapy regimens.

5 Medication precautions

(1) Differentiation syndrome: Approximately 3% -11% of patients may experience symptoms such as fever and difficulty breathing, requiring immediate use of dexamethasone and suspension of medication.

(2) Abnormal electrocardiogram: Regular monitoring of QT interval is necessary during treatment to avoid combination with potent CYP3A inhibitors.

(3) Risk of pancreatitis: Discontinue medication when abdominal pain or elevated amylase levels occur until symptoms improve.

(4) Embryotoxicity: Patients of childbearing age should take effective contraceptive measures and avoid pregnancy during treatment and for 6 months after discontinuation of medication.

6. Medication for special populations

(1) Liver dysfunction: Moderate injuries should be reduced to 80mg/day, while severe injuries should be avoided.

(2) Elderly patients: People aged 65 and above are more prone to adverse reactions, and it is recommended to strengthen monitoring.

Disclaimer:《Has Gilteritinib been launched in China? What are the precautions for medication?》Edited and sorted by Seagull Pharmacy's editors. Please contact us in time if there is any infringement. In addition, the suggestions for drug usage, dosage and disease mentioned in the article are only for medical staff's reference, and can not be used as any basis for medication!

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