Pirfenidone

Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of IPF. Titration: Days 1-7, 267 mg three times a day (801 mg/day); Days 8-14, 534 mg three times a day (1602 mg/day); Day 15 onward, 801 mg three times a day (2403 mg/day). Patients who miss 14 consecutive days or more must re-initiate with the full 2-week titration; for interruption of less than 14 days the previous dose can be resumed without titration. Gastrointestinal intolerance: take with food; if symptoms persist the dose may be reduced to 267 mg - 534 mg two to three times a day with food, with re-escalation as tolerated, or treatment interrupted for one to two weeks. Mild to moderate photosensitivity reaction or rash: use sunblock daily, avoid sun, and the dose may be reduced to 801 mg each day (267 mg three times a day); if rash persists after 7 days discontinue for 15 days then re-escalate. Elderly: no dose adjustment. Hepatic impairment: no dose adjustment in Child-Pugh A or B but use with caution; must not be used in severe hepatic impairment or end stage liver disease. Paediatric: the SPC states there is no relevant use of Esbriet in the paediatric population for IPF. Interactions listed below are from the US FDA label section 7 because SPC section 4.5 was not captured in this bundle; eMC sections 4.4 and 4.8 were truncated at the source-fetch limit. Source product: Esbriet 267 mg film-coated tablets.