pirfenidone: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
pirfenidone: clinical details
Prescribing considerations
- Initiation and supervision should be by a specialist experienced in diagnosing and treating IPF.
- Review hepatic and renal function, interacting medicines, smoking status and previous pirfenidone reactions before treatment.
- Counsel about food administration, photosensitivity prevention, serious skin reactions and liver-injury symptoms.
- Monitor weight and nutritional status; consider serum sodium assessment when compatible symptoms occur.
Contraindications and cautions
- Hypersensitivity to pirfenidone or an excipient
- Previous pirfenidone-associated angioedema
- Concurrent fluvoxamine
- Severe hepatic impairment or end-stage liver disease
- Severe renal impairment or end-stage renal disease requiring dialysis
Monitoring
- Measure ALT, AST and bilirubin before treatment and monitor liver function during treatment.
- Arrange prompt clinical assessment and liver testing if symptoms suggest hepatic injury.
- Monitor tolerability, rash or photosensitivity, weight loss and clinically relevant gastrointestinal effects.
Clinical pharmacology
Pirfenidone has antifibrotic and anti-inflammatory properties. It attenuates fibroblast proliferation, fibrosis-associated mediators and extracellular-matrix accumulation. Metabolism is predominantly through CYP1A2, with smaller contributions from other CYP enzymes; elimination is mainly urinary as a metabolite.
Formulation and product differences
- The selected product is a film-coated oral tablet intended to be swallowed whole with water and taken with food.
pirfenidone preparations and strengths
Tablet
Route: Oral
Strengths: 267 mg, 534 mg, 801 mg
pirfenidone interactions
Check all prescribed, over-the-counter and herbal products with the specialist team or pharmacist. Important interactions include:
Fluvoxamine
Strongly increases pirfenidone exposure and must not be used with it.
Ciprofloxacin and other CYP1A2 inhibitors
May increase pirfenidone exposure and adverse effects, requiring specialist review and closer monitoring.
Amiodarone or propafenone
May inhibit pirfenidone metabolism; use requires caution and monitoring for toxicity.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.