ESBRIET (PIRFENIDONE) PROVIDES FLEXIBLE DOSING TO HELP MANAGE ADVERSE EVENTS (AEs) 2

Individual 267mg tablets allow for tailored dose modification to help manage potential AEs

Dose modification, interruption, or discontinuation may be appropriate to help manage side effects

ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal.

 

Reinitiating treatment following treatment interruptions

  • Patients who miss 14 or more days of Esbriet should reinitiate treatment by repeating the initial 2-week titration regimen
  • For a treatment interruption of fewer than 14 days, the dosage taken prior to the interruption can be resumed

 

ESBRIET OFFERS STRATEGIES TO HELP PATIENTS MANAGE AEs

Under physician guidance, patients may manage some AEs with everyday strategies and resources

In a post hoc analysis evaluating Esbriet dose adjustments for all AEs during three phase 3 trials pooled at 12 months 23*:

Dose reductions in 3 out of 5 patients were temporary

  • 59% of patients who had dose reductions with Esbriet were temporary (n=283/479 with dose reductions overall; 623 total patients) vs 71% with placebo (n=319/449 with dose reductions overall; 624 total patients)

Median cumulative days of dose reduction: 38 days (IQR: 9–103) with Esbriet vs 29 days (range: 7–95) with placebo

Median cumulative days of dose interruption for Esbriet was 14 (IQR: 3–29) vs 4 (IQR: 1–13) for placebo

*Dose adjustments included dose reductions and dose interruptions. Dose reductions and interruptions were analyzed using descriptive statistics. A dose reduction was defined as any decrease to an Esbriet dose lower than 2403 mg/day after the first 2 weeks of treatment (excluding a zero dose), as reported by the patient. This reduction was temporary if the Esbriet dose was then increased back to 2403 mg/day. A dose interruption was defined as any reported dosing gap to a zero dose of Esbriet after the first 2 weeks of dose titration. Dose reductions or interruptions had no prespecified duration and could be temporary or permanent.