Esbriet (pirfenidone) offers established safety built on multiple clinical studies 2
Safety data were obtained from 1247 patients in 3 randomized, controlled trials
*Includes abdominal pain, upper abdominal pain, abdominal distension, and stomach discomfort.
- The most common adverse reactions (>1%) leading to discontinuation were rash and nausea
- The most common AEs (>3%) leading to dosage reduction or interruption were rash, nausea, diarrhea, and photosensitivity reaction
- Serious AEs, including elevated
liver enzymes and drug-induced liver injury, photosensitivity
reactions, and gastrointestinal (GI) disorders, have been reported
Tolerability with Esbriet
SOME AEs WITH ESBRIET WERE MILD TO MODERATE, OCCURED EARLY, AND DECREASED OVER TIME 2
The first dermatologic AE tended to occur within the first 2 to 3 months of treatment and GI and nausea AEs during the peri-titration period. 19
PHOTOSENSITIVITY REACTIONS AND GI EVENTS TYPICALLY OCCURRED IN THE FIRST 3 TO 6 MONTHS OF TREATMENT AND INFREQUENTLY LED TO DISCONTINUATION 1,2
- The majority of photosensitivity reactions occurred in the first 6 months of treatment 2
- Incidence was 9% with Esbriet vs 1% with placebo 2
- Median time to first photosensitivity AE was 90 (IQR: 48.0–149.0) days 19,20†
- <1% discontinuation due to photosensitivity with Esbriet 1
†Median time to first AE of interest.
Flexible dosing (dose modification, interruptions, discontinuations) with Esbriet 267 mg may help manage potential AEs like GI events and photosensitivity reactions. 2 See Adverse Event Management for more on managing AEs
Long-term, open-label, phase 3 extension study
Follow-up safety data available for up to 6.7 years 21
- In a long-term, open-label extension of the phase 3 studies, 1058 patients with IPF were exposed to Esbriet (2403 mg/day) for a median of 88 weeks/1.7 years (range, >0 to 349 weeks/6.7 years) with the primary objective of obtaining additional safety data for Esbriet 2403 mg/day
- 40.4% (n=427) completed the study, with an overall
discontinuation rate of 59.2% (n=626)
- The most frequent adverse drug reactions were nausea (21.6%), diarrhea (12.3%), and rash (11.6%)‡
- The most common treatment-emergent serious adverse events were IPF (21.7%) and pneumonia (8.5%)‡
- 42% (n=444) discontinued due to treatment-emergent adverse events, including 16.8% (n=178) who discontinued due to IPF§
- Care should be exercised when interpreting open-label results due to the inability to minimize bias. The data represented are not designed to establish the long-term safety or tolerability profile for Esbriet
‡Adverse drug reactions are defined as AEs judged by the
investigator as possibly or probably related to pirfenidone.
§Treatment-emergent AEs are defined as all events that occurred from the first dose of pirfenidone through 28 days after the last dose in the long-term, open-label, phase 3 extension study.