Atled Fanregratinib Application Scope

Fanregratinib Tartrate Tablets (ATLED®) are indicated for the treatment of adult patients with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (ICC) harboring fibroblast growth factor receptor 2 (FGFR2) fusions or rearrangements who have previously received systemic therapy.

Fanregratinib Characteristics

Ingredients: Fanregratinib tartrate
Properties: An oral selective FGFR1/2/3 tyrosine kinase inhibitor.
Packaging Specification: 50 mg per tablet, 42 tablets per bottle.
Storage: Store according to the conditions specified in the official package insert.
Expiry Date: Refer to the expiry date stated on the package.
Executive Standard: Refer to the official product standard.
Approval Number: NMPA Approval No. H20260057.
Date of Revision: Refer to the latest approved package insert.
Manufacturer: Hutchmed (Shanghai) Pharmaceuticals Co., Ltd.

Guidelines for the Use of Atled

Dosage and Administration:
- Recommended Dose: The recommended dosage is 300 mg once daily for 14 consecutive days, followed by 7 days off.
- Administration: Administer orally as directed by a healthcare professional.
- Missed Dose: Take the missed dose as soon as possible unless it is close to the next scheduled dose.
Adverse Reactions:
- Common Adverse Reactions: Common adverse reactions include elevated liver enzymes, liver function abnormalities, hand-foot syndrome, and visual impairment.
- Serious Adverse Reactions: Grade ≥3 treatment-related adverse events occurred in 48.3% of patients in the registrational clinical study.
Contraindications: Contraindicated in patients with a known hypersensitivity to Atled or any of its excipients.
Precautions:
- Monitor liver function regularly during treatment.
- Monitor for hand-foot syndrome and other skin reactions during treatment.
- Monitor for visual disturbances and promptly report any changes in vision.
- Patients should inform their healthcare provider about all concomitant medications before starting treatment.
- Treatment interruption or dose adjustment may be required based on adverse reactions and should be determined by a healthcare professional.

Fanregratinib Interactions

CYP3A Inhibitors: Concomitant use with strong CYP3A inhibitors may increase fanregratinib exposure and should be used with caution.
CYP3A Inducers: Concomitant use with strong CYP3A inducers may reduce fanregratinib exposure and should be avoided when possible.
P-gp Inhibitors: Concomitant use with P-gp inhibitors may affect fanregratinib exposure and requires clinical consideration.
Other Medications: Patients should inform their healthcare provider about all prescription medicines, over-the-counter medicines, and supplements they are taking.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.