Infigratinib is a kinase inhibitor targeting FGFR (fibroblast growth factor receptor), which has been granted accelerated approval by the U.S. FDA for the treatment of specific types of cholangiocarcinoma.

Indications for Infigratinib

Main Indications

Infigratinib’s indication is specifically for treating a certain type of cholangiocarcinoma in adult patients.

Target Population

Patients with locally advanced or metastatic cholangiocarcinoma that is unresectable and has been previously treated.

The tumor must have confirmed FGFR2 gene fusion or other rearrangements detected by an FDA-approved testing method.

Prerequisite for Use

Molecular testing must confirm FGFR2 gene abnormalities before treatment to avoid ineffective therapy.

Specifications and Properties of Infigratinib

Dosage Form and Strength

25mg capsules: White opaque capsule body with gray opaque capsule cap; the body is printed with black text "INFI 25mg".

100mg capsules: White opaque capsule body with light orange opaque capsule cap; the body is printed with black text "INFI 100mg".

Active Ingredient

Each capsule contains infigratinib phosphate, with the chemical name 3-(2,6-dichloro-3,5-dimethoxyphenyl)-1-{6-[4-(4-ethylpiperazin-1-yl)anilino]pyrimidin-4-yl}-1-methylurea phosphate (1:1).

Excipient Composition

Colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, vegetable-derived magnesium stearate, and microcrystalline cellulose.

The capsule shell contains iron oxide black/red/yellow, gelatin, and titanium dioxide; the printing ink contains potassium hydroxide, shellac, and other ingredients.

Packaging Specifications

Blister packs for a 21-day treatment course are available, including four dosage combinations:

50mg (42×25mg capsules).

75mg (63×25mg capsules).

100mg (21×100mg capsules).

125mg (21×100mg capsules + 21×25mg capsules).

Storage Methods for Infigratinib

Temperature Requirement

Store at 20°C to 25°C (68°F to 77°F) under normal conditions; short-term storage at 15°C to 30°C (59°F to 86°F) is allowed.

Storage Precautions

Avoid exposure to high temperatures, moisture, and direct sunlight to prevent denaturation of capsule components.

Keep the original packaging intact; take the capsule immediately after removal. Do not crush or dissolve it in advance.