Pirfenidone

Dosage and Administration (2.3)                                  02/2023

Warnings and Precautions (5.3)                                   02/2023

Pirfenidone tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).

• Take with food.

• Recommended dosage: 801 mg three times daily (2403 mg/day). (2)

• Upon initiation of treatment, titrate to the full dosage of 2403 mg/day over a 14-day period as follows:

• 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. (2.1)

Pirfenidone tablets are available as:

• 267 mg, yellow, oval, biconvex, film coated tablet, debossed with “L” on one side and “749” on other side.
• 801 mg, brown, oval, biconvex, film coated tablet, debossed with “L” on one side and “750” 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. (8.6, 12.3)

• 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. (8.7, 12.3)

• Smokers: Decreased exposure has been noted in smokers which may  alter the efficacy profile of pirfenidone. (8.8)