Pirfenidone
ESBRIET
What it isTGF-beta-modulating antifibrotic; idiopathic pulmonary fibrosis.
Why this oneUnlike nintedanib, its tolerability profile centers on photosensitivity and appetite or weight loss rather than diarrhea.
What limits itGI upset, weight loss and photosensitivity limit use; monitor liver tests. CYP1A2 interactions matter, and smoking lowers exposure.
FDA-approved for
- idiopathic pulmonary fibrosis (2014)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Idiopathic pulmonary fibrosis | Adult | 267 mg TID | 801 mg TID (2,403 mg/day) | 2,403 mg/day |
Titration Days 1-7: 267 mg TID; days 8-14: 534 mg TID; day 15 onward: 801 mg TID
Renal Use with caution in mild/moderate/severe impairment; not recommended in ESRD on dialysis
Hepatic Use with caution in mild/moderate (Child-Pugh A/B); not recommended in severe (Child-Pugh C)
Instructions
- Take with food at the same time each day
- Conduct liver function tests before and during treatment
- Avoid sunlight/sunlamps; use sunscreen (SPF 50+) and protective clothing
- Stop smoking before and during treatment
- If ≥14 days missed, re-initiate with 2-week titration
Cautions
- Elevated liver enzymes and drug-induced liver injury (including fatal)
- Photosensitivity reaction or rash
- Severe cutaneous adverse reactions (SJS, TEN, DRESS)
- Gastrointestinal disorders (nausea, vomiting, diarrhea, dyspepsia, GERD, abdominal pain)
Adverse reactions
- Nausea
- Rash
- Abdominal pain
- Upper respiratory tract infection
- Diarrhea
- Fatigue
- Headache
- Decreased appetite
- Dyspepsia
- Dizziness
- Vomiting
- GERD
Pregnancy Insufficient human data; not teratogenic in animals.
Lactation No information on presence in human milk.
NO BOXED WARNINGS
Principal riskPhotosensitivity and weight loss
Cost, est. cash$100–$5,000/month
Generic entry2022
Classes and tags
Clinical profile
Legacy pregnancy categoryC
Defining liabilitySerious infection, cytopenias, hepatic injury and malignancy risk require laboratory and clinical monitoring.
Mechanism of action: Pirfenidone ballicule
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