Idiopathic pulmonary fibrosis: Treatment of idiopathic pulmonary fibrosis (IPF)

Anti-inflammatory Agent; Antifibrotic Agent

Half-life elimination: ~3 hours Time to peak, plasma: Median: 0.5 hours (fasting); 3 hours (with food) Excretion: Urine (~80%; >99% as metabolite)

severe hepatic impairment or end-stage liver disease; severe renal impairment (CrCl <30 mL/minute) or end-stage renal disease (ESRD) requiring dialysis.

Adverse events have been observed in animal reproduction studies.

It is not known if pirfenidone is present in breast milk. According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Fatigue, headache, dizziness,Skin rash, skin photosensitivity,Nausea, diarrhea, abdominal pain, dyspepsia, anorexia , vomiting

Adult Idiopathic pulmonary fibrosis (IPF): Oral: Days 1 to 7: 267 mg 3 times daily (total dose: 801 mg/day) Days 8 to 14: 534 mg 3 times daily (total dose: 1,602 mg/day) Day 15 and thereafter: 801 mg 3 times daily (total dose: 2,403 mg/day). Maximum dose: 2,403 mg/day. Reinitiation of therapy following interruption: If interruption <14 consecutive days, may reinitiate therapy at previous daily dose without retitration; if interruption ?14 consecutive days, reinitiate therapy with the initial 2-week titration period up to recommended daily dose.

Safety and efficacy not established in pediatric patients

Mild to severe impairment: Use with caution; consider dose modification or discontinuation as needed. ESRD requiring dialysis: Use is not recommended (has not been studied).

Mild to moderate impairment (Child-Pugh class A and B): Use with caution; consider dose modification or discontinuation as needed. Severe impairment (Child-Pugh class C): Use is not recommended (has not been studied).

Store at 25 degrees C.