Pirfenidone

Dosage and Administration                                                             02/2023

Warnings and Precautions                                                              02/2023

Pirfenidone tablet is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).

• Take with food.
• Recommended dosage: 801 mg three times daily (2403 mg/day).
• Upon initiation of treatment, titrate to the full dosage of 2403 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 (1602 mg/day)
  Days 15 onward	801 mg three times daily (2403 mg/day)

• Consider temporary dosage reduction, treatment interruption, or discontinuation for management of adverse reactions.
• Prior to treatment, conduct liver function tests.

Film-coated tablets: white colored, oval shaped, debossed with “M" on one side “PF1" (267 mg) and “PF3" (801 mg) on other side.

•  Hepatic Impairment: Monitor for adverse reactions and consider dosage modification or discontinuation of pirfenidone as needed. Pirfenidone is not recommended for use in patients with severe hepatic impairment.
• Renal Impairment: Monitor for adverse reactions and consider dosage modification or discontinuation of pirfenidone as needed. Pirfenidone is not recommended for use in patients with end stage renal disease on dialysis.
• Smokers: Decreased exposure has been noted in smokers which may alter the efficacy profile of pirfenidone.