Pirfenidone

What it is and how it works

Mechanism of Action The mechanism of action of pirfenidone in the treatment of IPF has not been established.

Indications

Pirfenidone capsules are indicated for the treatment of idiopathic pulmonary fibrosis (IPF). Pirfenidone is a pyridone indicated for the treatment of idiopathic pulmonary fibrosis (IPF).

Dosage and administration (summary)

Take with food. Recommended dosage: 801 mg three times daily (2,403 mg/day). Upon initiation of treatment, titrate to the full dosage of 2,403 mg/day over a 14-day period as follows: Treatment days Dosage Days 1 through 7 267 mg three times daily (801 mg/day) Days 8 through 14 534 mg three times daily (1,602 mg/day) Days 15 onward 801 mg three times daily (2,403 mg/day) Consider temporary dosage reduction, treatment interruption, or discontinuation for management of adverse reactions. ( 2.3 , 5.1 , 5.2 , 5.3 , 5.4 ) Prior to treatment, conduct liver function tests.

Contraindications

None. None

Warnings and precautions

Elevated liver enzymes and drug-induced liver injury: ALT, AST, and bilirubin elevations have occurred with pirfenidone including cases of drug-induced liver injury. In the post-marketing setting, non-serious and serious cases of drug-induced liver injury, including severe liver injury with fatal outcomes, have been reported. Monitor ALT, AST, and bilirubin before and during treatment. Temporary dosage reductions or discontinuations may be required. ( 2.1 , 5.1 ) Photosensitivity and rash: Photosensitivity and rash have been noted with pirfenidone. Avoid exposure to sunlight and sunlamps.

Pregnancy

Pregnancy Risk Summary The data with pirfenidone use in pregnant women are insufficient to inform on drug associated risks for major birth defects and miscarriage. In animal reproduction studies, pirfenidone was not teratogenic in rats and rabbits at oral doses up to 3 and 2 times, respectively, the maximum recommended daily dose (MRDD) in adults .…

Storage and supply

Pirfenidone Capsules USP, 267 mg are supplied as opaque white to off-white cap and opaque white to off-white body, imprinted with "AMNEAL” and “1642" on cap with black ink. They are available as follows: Bottles of 270: NDC 42291-490-27 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) .

Source: Pirfenidone (Pirfenidone) — US FDA prescribing information, 2026-01-14, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.