PIRFENIDONE TAB,ORAL
Clinical Criteria Summary
Criteria for Pirfenidone (ESBRIET) for Idiopathic Pulmonary Fibrosis (IPF)
- (Applies to PIRFENIDONE CAP,ORAL and PIRFENIDONE TAB,ORAL)
- Exclusion Criteria (Patient should NOT receive pirfenidone if ANY of the following are met):
- Presence of liver function test abnormalities (may be temporary or permanent exclusion depending on severity and pattern)
- Severe hepatic impairment (Child Pugh C)
- End stage renal disease requiring dialysis
- Current smoker (reduced pirfenidone exposure)
- Concurrent treatment with nintedanib (no evidence of benefit with combination)
- Patient is taking a combination of moderate or strong CYP1A2 inhibitors with other drugs which also inhibit CYP isoenzymes involved in the metabolism of pirfenidone (2C9, 2C19, 2D6, and 2E1) which cannot be altered or discontinued
- Planned continuation of strong CYP1A2 inducer (decreased pirfenidone exposure)
- Inclusion Criteria (All of the following must be met):
- Care provided by VA/VA Community Care pulmonologist experienced in the management of interstitial lung disease (ILD)
- Confirmed interstitial pulmonary fibrosis (IPF) diagnosis using clinical, radiologic and if applicable histopathologic information
- Additional Inclusion Criteria (Select if applicable):
- Patients receiving treatment with pirfenidone and nerandomilast: Prescribed the 18 mg twice daily dose of nerandomilast (nerandomilast dose should not be reduced)
- For patients who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy
- For patients who are lactating and providing breastmilk to infant: Counseling provided on potential risks vs. benefits of treatment