Esbriet 267 & 801 267 mg, 801 mg Tablet
PDF Leaflet Revision Date: 18 July 2023
Clinical Summary
Quick overview from the medicine insert
Indication
Reduction of progression of mild to moderately severe idiopathic pulmonary fibrosis (IPF) in non-smoking and former-smoking adults.
Dosage (summary)
Initial: 267 mg TID for 7 days, then 534 mg TID for 7 days, then 801 mg TID (total 2403 mg/day).
Special Populations
- Elderly
- Hepatic impairment
- Renal impairment
Pregnancy & Breastfeeding
Contraindicated in pregnancy and breastfeeding.
Key Drug Interactions
- Fluvoxamine
- Strong CYP1A2 inducers
- Cigarette smoking
Contraindications
- Hypersensitivity to pirfenidone
- Severe hepatic impairment
- Severe renal impairment
- History of angioedema
Common side effects
- Nausea
- Diarrhoea
- Fatigue
- Rash
- Dizziness
Counselling Points
- Take with food to reduce nausea
- Avoid sun exposure
- Monitor for liver function abnormalities
Serious warnings
- Drug-Induced Liver Injury
- Photosensitivity reactions
- Angioedema
Important Disclaimer
The Esbriet 267 & 801 267 mg, 801 mg Tablet professional information leaflet below is the property of Roche Products and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>
Healthcare Professionals Only
This content is for registered healthcare professionals
Sign in or create a free account to read the full package insert.
Free for HPCSA-registered professionals. Powered by Medinsert.
