PIRFENIDET

What it is

PIRFENIDET contains pirfenidone and is available as 267 mg and 801 mg film-coated tablets.

Approved indications

— Idiopathic pulmonary fibrosis (IPF).

Dosing overview

The recommended daily dose of PIRFENIDET for patients with IPF is 801 mg three times a day with food, for a total of 2403 mg/day. Dose titration should occur over a 14-day period: Days 1 to 7 at 267 mg three times a day (801 mg/day), Days 8 to 14 at 534 mg three times a day (1602 mg/day), and Day 15 onward at 801 mg three times a day (2403 mg/day). Treatment should be initiated by physicians experienced in the diagnosis and treatment of IPF.

Key safety warnings

Drug-induced liver injury in the form of transient and clinically silent elevations in transaminases has been commonly reported in patients treated with PIRFENIDET. Uncommonly, these elevations were associated with concomitant bilirubin increases, and serious clinical consequences including isolated cases with fatal outcome have been reported post-marketing. Liver function tests (ALT, AST, and bilirubin) should be performed prior to the initiation of therapy with PIRFENIDET in all patients, then monthly for the first 6 months and every 3 months thereafter. Exposure to direct sunlight (including sunlamps) should be avoided or minimized during treatment with PIRFENIDET. Patients should be instructed to use an effective sunblock daily, to wear clothing that protects against sun exposure, and to avoid other medicinal products known to cause photosensitivity. Reports of angioedema (some serious) such as swelling of the face, lips and/or tongue which may be associated with difficulty breathing or wheezing have been received in association with use of PIRFENIDET in the post-marketing setting. Reports of anaphylactic reactions have also been received. Severe cutaneous adverse reactions (SCAR), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with the use of PIRFENIDET in the postmarketing setting. The exposure to pirfenidone in smokers was 50% of that observed in non-smokers. Concomitant use of strong inducers of CYP1A2 including smoking should be avoided during PIRFENIDET therapy.

Contraindications

Hypersensitivity to the active substance or to any of the excipients, concomitant use of fluvoxamine, and history of angioedema with pirfenidone are contraindicated. Severe hepatic impairment or end stage liver disease is contraindicated. Severe renal impairment (CrCl <30 ml/min) or end stage renal disease requiring dialysis is contraindicated.

Regulatory history

PIRFENIDET pirfenidone 267 mg and 801 mg film-coated tablet bottles were first listed on the ARTG on 15 February 2023.