Futibatinib is an oral kinase inhibitor that was first approved for marketing in the United States in 2022. As a targeted therapy, it is mainly indicated for the treatment of advanced cholangiocarcinoma with specific genetic mutations.

What are the Indications of Futibatinib?

Primary Indications

Futibatinib is indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma.

Its administration is predicated on the presence of specific genetic mutations in the patient's tumor.

Key Biomarker Requirements

Prior to treatment with futibatinib, it is mandatory to confirm the presence of fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements in the patient's tumor through relevant testing.

This is a prerequisite for the drug to exert its therapeutic effects, embodying the principle of "test first, treat later" in modern precision medicine.

Dosage Forms, Specifications, and Properties of Futibatinib

Dosage Forms and Specifications

4 mg tablets: Round, white, engraved with "4MG" on one side and "FBN" on the other side.

16 mg tablets: Round, white, engraved with "16MG" on one side and "FBN" on the other side.

Properties and Composition

Futibatinib itself is a white crystalline powder.

The active ingredient of the tablet is futibatinib.

Inactive ingredients include corn starch, crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, and sodium lauryl sulfate.

The film-coating materials consist of hypromellose, magnesium stearate, polyethylene glycol, and titanium dioxide.

Storage Methods and Precautions for Futibatinib

Storage Conditions

Futibatinib tablets should be stored at room temperature between 20°C and 25°C (68°F and 77°F).

Short-term deviations from this range are acceptable, with a permissible temperature interval of 15°C to 30°C (59°F to 86°F).

The medicinal product should be kept in its original packaging to protect it from moisture and light exposure.

Administration and Handling Precautions

Administration method: The tablets should be swallowed whole; do not crush, chew, split, or dissolve them. They can be taken with food or on an empty stomach, but it is recommended to take them at approximately the same time each day.

Missed dose handling: If a dose is missed, take the missed dose as soon as possible within 12 hours of remembering. If more than 12 hours have elapsed, skip the missed dose and take the regular dose at the usual time the next day. Do not take a double dose to make up for the missed one.

Vomiting handling: If vomiting occurs after administration, do not take an extra dose. Resume the next scheduled dose the following day as planned.

Pediatric safety: This product must be stored out of the reach and sight of children, and the packaging is designed with child-resistant features.