PEMAZYRE (pemigatinib)

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