INDICATIONS AND USAGE

Pirfenidone is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).

DOSAGE

The recommended daily maintenance dosage of ESBRIET is 801 mg three times daily for a total of 2403 mg/day. Doses should be taken with food at the same time each day.

Upon initiation of treatment, titrate to the full dosage of 2403 mg/day over a 14-day period as follows:

Days 1 through 7: 267 mg three times daily (801 mg/day)

Days 8 through 14: 534 mg three times daily (1602 mg/day)

Days 15 onward: 801 mg three times daily (2403 mg/day)

ADVERSE REACTIONS

Liver Enzyme Elevations and Drug-Induced Liver Injury

Photosensitivity Reaction or Rash

Gastrointestinal Disorders

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e/spl-doc?hl=Pirfenidone

pirfenexinformation