Pirfenidone Dosage

Medically reviewed by Drugs.com. Last updated on Aug 18, 2023.

Applies to the following strengths: 267 mg; 801 mg; 534 mg

Usual Adult Dose for:

Idiopathic Pulmonary Fibrosis

Additional dosage information:

Renal Dose Adjustments
Liver Dose Adjustments
Dose Adjustments
Precautions
Dialysis
Other Comments

Usual Adult Dose for Idiopathic Pulmonary Fibrosis

Initial dose:

Days 1 to 7: 267 mg (one capsule) orally three times a day
Days 8 to 14: 534 mg (two capsules) orally three times a day

Maintenance/Maximum dose (Day 15 onward): 801 mg (three capsules) orally three times a day

Comments:

Take with food to reduce nausea and dizziness.
Doses should be taken at the same time each day.

Use: Idiopathic pulmonary fibrosis (IPF)

Renal Dose Adjustments

Mild to severe renal impairment (CrCl 80 mL/min or less): Use with caution
End-stage renal disease requiring dialysis: Not recommended

Liver Dose Adjustments

Mild to moderate liver impairment (Child-Pugh A and B): Use with caution
Severe liver impairment (Child-Pugh C): Not recommended

If hepatotoxicity develops during treatment:

ALT and/or AST greater than 3 but less than or equal to 5 times the upper limit of normal (ULN) without symptoms or hyperbilirubinemia: Maintain or reduce full daily dose as clinically appropriate, or interrupt therapy with subsequent re-titration to the full dose as tolerated after discontinuing confounding medications and excluding other causes.
ALT and/or AST greater than 3 but less than or equal to 5 X ULN accompanied by symptoms or hyperbilirubinemia: Permanently discontinue treatment and do not re-challenge patient with this drug.
ALT and/or AST greater than 5 X ULN: Permanently discontinue treatment and do not re-challenge patient with this drug.

Dose Adjustments

Treatment interruption 14 days or more: Re-initiate therapy by undergoing the initial 2-week titration regimen up to the full maintenance dose of 801 mg (three capsules) orally three times a day.
Treatment interruption less than 14 days: Resume daily dose prior to interruption.
Significant adverse reactions (i.e. GI, photosensitivity reaction or rash): Consider temporary dose reductions or treatment interruptions to allow for resolution of symptoms.
Concomitant use of strong CYP450 1A2 inhibitors: Reduce dose to 267 mg (one capsule) orally three times a day.
Concomitant use of ciprofloxacin 250 mg or 500 mg once daily: Close monitoring recommended.
Concomitant use of ciprofloxacin 750 mg twice daily: Reduce dose to 534 mg (2 capsules) orally three times a day.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Not recommended

Other Comments

Administration advice:

Dosages above 2403 mg per day (9 capsules) are not recommended.

Monitoring:

Conduct liver function tests (ALT, AST, and bilirubin) prior to treatment initiation, at monthly intervals for the first 6 months, and then every 3 months thereafter.
Closely monitor patients with aminotransferase elevations more than 3 times the upper limit of normal (ULN) after starting treatment.
Monitor closely for signs of toxicity and adverse reactions, especially in hepatically impaired patients concomitantly taking a CYP450 1A2 inhibitor.

Patient advice:

Avoid grapefruit, grapefruit juice, and smoking as they may affect how well this drug works.
This drug can make your skin sensitive to light from the sun, sunlamps, and tanning beds. Avoid sun exposure, use sunblock (SPF 50 or higher) every day, and wear a hat and clothes that cover your skin when you're exposed to sunlight.