PEMAZYRE (pemigatinib)
SELF ADMINISTRATION - Oral
Indication for Prior Authorization:
- 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
Patients must meet the following criteria for the indication(s) above:
- Patient is 18 years of age or older, AND
- Prescribed by or in collaboration with a hepatologist, gastroenterologist or oncologist, AND
- Chart note documentation provided confirms diagnosis of cholangiocarcinoma, AND
- Disease is one of the following:
- Unresectable locally advanced, OR
- Metastatic, AND
- Disease has presence of a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement, AND
- Patient has been previously treated
Dosing:
- 13.5 mg orally once daily for 14 consecutive days followed by 7 days off therapy, in 21-day cylces. Continue until disease progression or unacceptable toxicity occurs.
- Dose adjusted for adverse reactions
- First dose reduction: 9 mg once daily for first 14 days of each 21-day cycle
- Second dose reduction: 4.5 mg once daily for first 14 days of each 21-day cycle
- Permanently discontinue if unable to tolerate 4.5 mg once daily
- Avoid concomitant use of strong and moderate CYP3A inhibitors with Pemazyre™. Reduce dose of Pemazyre™ if concomitant use with a strong or moderate CYP3A inhibitor cannot be avoided.
Approval:
- 1 year
Last review date: August 18, 2020