INDICATIONS AND USAGE（适应症）

PEMAZYRE 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 locally advanced or metastatic cholangiocarcinoma with PEMAZYRE based on the presence of an FGFR2 fusion or rearrangement as detected by an FDA-approved test.

Recommended Dosage

The recommended dosage of PEMAZYRE is 13.5 mg orally once daily for 14 consecutive days followed by 7 days off therapy, in 21-day cycles. Continue treatment until disease progression or unacceptable toxicity occurs.

Take PEMAZYRE with or without food at approximately the same time every day.

Swallow tablets whole. Do not crush, chew, split, or dissolve tablets.

If the patient misses a dose of PEMAZYRE by 4 or more hours or if vomiting occurs, resume dosing with the next scheduled dose.

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/9e1f2222-1d89-4e63-989c-ccebe2ab1eb4/spl-doc?hl=Pemazyre

Pemazyreinformation