Pirfenidone (Generic) (Pirfenidone TABLET, FILM COATED) 267 mg/1

Pirfenidone is an oral antifibrotic agent approved by the FDA for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive lung disease characterized by lung tissue scarring. It received orphan drug designation due to its use in this rare disease. Pirfenidone is classified as a disease-modifying therapy in the pulmonology therapeutic area.

Strength

267 mg/1

Pack Size

270 TABLET, FILM COATED in 1 CARTON (0781-8085-32)

Manufacturer / TM Owner

Generic

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Indications & Clinical Uses

Pirfenidone is indicated for the treatment of idiopathic pulmonary fibrosis (IPF) in adult patients. IPF is a rare, progressive, and irreversible lung disease characterized by abnormal wound healing and excessive collagen deposition leading to pulmonary fibrosis. The drug is primarily used in patients with mild to moderate IPF to slow disease progression and preserve lung function. Pirfenidone's mechanism of action involves inhibition of multiple profibrotic cytokines and growth factors, including transforming growth factor-beta (TGF-β) and tumor necrosis factor-alpha (TNF-α), which are central to the fibrotic cascade. Clinical trials have demonstrated that pirfenidone reduces the decline in forced vital capacity (FVC) and improves progression-free survival. The drug is typically prescribed for patients diagnosed with biopsy-proven or high-resolution computed tomography (HRCT)-confirmed IPF who have evidence of disease progression.

Side Effects

Common side effects of pirfenidone include gastrointestinal disturbances such as nausea, diarrhea, dyspepsia, and abdominal pain, which occur in a significant proportion of patients. Photosensitivity reactions and rash are notable dermatological adverse events requiring sun protection counseling. Serious adverse events include hepatotoxicity, with elevated liver enzymes reported in clinical trials. Patients require regular monitoring of liver function tests (LFTs) at baseline, monthly for the first 6 months, then quarterly thereafter. Renal function monitoring is also recommended. Drug interactions and individual patient factors may necessitate dose adjustments or discontinuation.

Precautions & Warnings

Pirfenidone is contraindicated in patients with severe hepatic impairment or end-stage renal disease. Caution is warranted in patients with mild to moderate hepatic or renal dysfunction, requiring dose adjustments. The drug is not recommended during pregnancy due to potential teratogenic effects; women of childbearing potential should use effective contraception. Safety and efficacy in pediatric populations have not been established. Patients should avoid concurrent use with strong CYP1A2 inhibitors. Photosensitivity is a significant concern; patients must use broad-spectrum sunscreen and protective clothing. Regular hepatic and renal function monitoring is essential throughout treatment.

Avoid Interactions

Pirfenidone is metabolized primarily by CYP1A2, making it susceptible to significant drug interactions. Concurrent use with strong CYP1A2 inhibitors such as fluvoxamine, ciprofloxacin, and enoxacin may substantially increase pirfenidone concentrations and require dose reduction. Moderate CYP1A2 inhibitors including oral contraceptives and some antiarrhythmics may also elevate drug levels. Conversely, CYP1A2 inducers may decrease pirfenidone efficacy. Patients should avoid smoking, which induces CYP1A2 activity. NSAIDs may increase gastrointestinal side effects.

Frequently Asked Questions

Pirfenidone is used to treat idiopathic pulmonary fibrosis (IPF), a rare progressive lung disease characterized by lung tissue scarring and fibrosis. It works by slowing disease progression and helping to preserve lung function in adult patients with mild to moderate IPF. The drug reduces the decline in lung function and improves progression-free survival.

Pirfenidone is administered orally as capsules, typically in a dose-escalation regimen starting at 267 mg three times daily and gradually increasing to a maintenance dose of 801 mg three times daily over 14 days. The medication should be taken with food to minimize gastrointestinal side effects and improve tolerability.

Common side effects include nausea, diarrhea, dyspepsia, abdominal pain, and photosensitivity reactions. Rash and elevated liver enzymes may also occur. Most gastrointestinal side effects are mild to moderate and tend to improve over time with continued use.

Pirfenidone is available as a generic medication from multiple manufacturers following patent expiration of the original branded formulation. Various pharmaceutical companies produce generic versions of pirfenidone globally.

Yes, pirfenidone received orphan drug designation from the FDA due to its use in treating idiopathic pulmonary fibrosis, which is a rare disease affecting fewer than 200,000 individuals in the United States. This designation provides regulatory incentives and market exclusivity benefits to encourage development of treatments for rare diseases.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated: 17 Jun 2026

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