Infigratinib

Infigratinib, a targeted drug produced by Lucius Pharmaceuticals for specific genetic abnormalities, provides a relatively precise and effective treatment option for patients with cholangiocarcinoma.

The following is a summary of the main drug information for Infigratinib.

Active Ingredient

Its main active ingredient is Infigratinib Phosphate.

Indicated Population

It is indicated for adult patients with unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 gene fusion or rearrangement who have received prior treatment.

Dosage and Administration

The recommended dose is 125 mg orally once daily, taken consecutively for 21 days followed by a 7-day drug holiday, forming a 28-day treatment cycle; it should be administered on an empty stomach.

Medication Use in Special Populations

Dose adjustment is required for patients with mild to moderate renal impairment or hepatic impairment; it is contraindicated in pregnant and lactating women. Women of childbearing potential and men with partners of childbearing potential should use effective contraception during treatment and for 1 month after discontinuation of the drug.

Drug Overdose

The specific management measures for drug overdose are not clearly mentioned in the documentation. During use, the drug should be strictly administered in accordance with medical advice to prevent accumulation.

Drug Storage

The drug should be stored sealed at room temperature between 20°C and 25°C, away from high temperatures or humidity.

Pharmacokinetics

The drug is slowly absorbed after oral administration, with a time to peak concentration of approximately 6 hours. It is mainly metabolized by CYP3A4, and both the parent drug and active metabolites exert pharmacological effects together.

FDA，2021.05