Pirfenidone

Preview FDA label, Aurobindo Pharma Limited, oral, effective 2026-04-22. Full label on DailyMed

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using. Not yet reviewed by a ClinDose pharmacist.

Dosing in kidney impairment

Renal Impairment Pirfenidone should be used with caution in patients with mild (CL cr 50 to 80 mL/min), moderate (CL cr 30 to 50 mL/min), or severe (CL cr less than 30 mL/min) renal impairment [see Clinical Pharmacology ]. Monitor for adverse reactions and consider dosage modification or discontinuation of pirfenidone as needed [ see Dosage and Administration ] .

The safety, efficacy, and pharmacokinetics of pirfenidone have not been studied in patients with end-stage renal disease requiring dialysis. Use of pirfenidone in patients with end-stage renal diseases requiring dialysis is not recommended.

Dosing in liver impairment

Testing Prior to Pirfenidone Capsules Administration Conduct liver function tests prior to initiating treatment with pirfenidone capsules [see Warnings and Precautions ].

Preparation and administration

If patients experience significant adverse reactions (i.e., gastrointestinal, photosensitivity reaction or rash, severe cutaneous adverse reactions (SCAR)), consider temporary dosage reductions or interruptions of pirfenidone capsules to allow for resolution of symptoms. If a SCAR is confirmed, permanently discontinue pirfenidone capsules [see Warnings and Precautions (5.1 , 5.2 , 5.3 , 5.4) ] .

Calculators for pirfenidone