INDICATIONS AND USAGE（适应症）

TRUSELTIQ is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

DOSAGE（服用剂量）

Select patients for the treatment of unresectable locally advanced or metastatic cholangiocarcinoma with TRUSELTIQ based on the presence of an FGFR2 fusion or rearrangement, as detected by an FDA-approved test.

Recommended Dosage

The recommended dosage of TRUSELTIQ is 125 mg (one 100 mg capsule and one 25 mg capsule) orally once daily for 21 consecutive days followed by 7 days off therapy, in 28-day cycles. Continue treatment until disease progression or unacceptable toxicity.

Instruct patients to take TRUSELTIQ on an empty stomach at least 1 hour before or 2 hours after food, at approximately the same time each day. Instruct patients to swallow capsules whole with a glass of water. Advise patients to not crush, chew, or dissolve capsules.

If a dose of TRUSELTIQ is missed by ≥4 hours or if vomiting occurs, instruct patients to resume the regular daily dose schedule for TRUSELTIQ the next day.

ADVERSE REACTIONS（不良反应）

Ocular Toxicity

Hyperphosphatemia and Soft Tissue Mineralization

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/af9a96cf-1cd7-8ace-e053-2a95a90a18cc/spl-doc?hl=Infigratinib

Infigratinibinformation