Pirfenidone Biogaran 267 mg

Pirfenidone Biogaran 267 mg

Overview

Pirfenidone Biogaran 267 mg is an anti-fibrotic and anti-inflammatory medicine indicated for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
It helps slow down the progression of lung scarring (fibrosis) and preserves lung function in patients suffering from chronic interstitial lung diseases.

This product is manufactured by Biogaran (France) and contains Pirfenidone 267 mg per film-coated tablet — a generic equivalent of the original Esbriet® (Roche).

Indications

Pirfenidone Biogaran 267 mg is prescribed for:

• Treatment of mild to moderate idiopathic pulmonary fibrosis (IPF) in adults.
  IPF is a progressive, chronic lung disease characterized by scarring of lung tissue, making it difficult for the lungs to work effectively.

Mechanism of Action

Pirfenidone works through anti-fibrotic, anti-inflammatory, and antioxidant mechanisms.
It:

• Inhibits fibroblast proliferation,
• Reduces production of fibrogenic mediators such as TGF-β and PDGF,
• Limits the deposition of extracellular matrix proteins in lung tissue.

As a result, Pirfenidone slows the rate of lung function decline, reduces fibrosis progression, and helps improve patient outcomes.

Dosage and Administration

Treatment must be started and monitored by a physician experienced in managing IPF.

Titration schedule:

• Days 1–7: 267 mg (one tablet) three times daily
• Days 8–14: 534 mg (two tablets) three times daily
• From Day 15 onward: 801 mg (three tablets) three times daily — maintenance dose

Important:

• Tablets must be taken with food to reduce the risk of gastrointestinal side effects.
• Swallow tablets whole with water — do not crush or chew.
• If treatment is interrupted for 14 days or more, the dose escalation schedule must be restarted.

Contraindications

Pirfenidone Biogaran 267 mg is contraindicated in patients with:

• Hypersensitivity to Pirfenidone or any excipients in the formulation.
• Severe hepatic impairment (Child-Pugh Class C).
• Severe renal impairment (CrCl < 30 mL/min).

Use with caution in patients with:

• History of liver disease or elevated liver enzymes,
• Phototoxic or photosensitivity reactions,
• Concomitant use of CYP1A2 inducers (e.g., smoking, omeprazole).

Adverse Effects

Common side effects:

• Nausea, vomiting, loss of appetite
• Diarrhea, stomach discomfort
• Tiredness, dizziness
• Skin rash, photosensitivity reactions
• Weight loss, fatigue
• Elevated liver enzymes (ALT, AST)

Serious or rare side effects:

• Hepatotoxicity (jaundice, dark urine, abdominal pain)
• Stevens–Johnson syndrome (extremely rare)
• Photosensitivity requiring avoidance of direct sunlight

Patients should be regularly monitored with liver function tests and clinical evaluations during therapy.

Composition

Each film-coated tablet contains:

• Active ingredient: Pirfenidone 267 mg
• Excipients: Microcrystalline cellulose, croscarmellose sodium, povidone, magnesium stearate, colloidal silica, and film-coating materials (hypromellose, titanium dioxide, iron oxide).