Antifibrotic (Tyrosine Kinase Inhibitor) Pregnancy: Contraindicated — teratogenic in animal studies; mandatory contraception

Nintedanib

Brand names: Ofev

Adult dose

Dose: 150 mg BD with food, separated by approximately 12 hours. Reduce to 100 mg BD if not tolerated.

Route: Oral

Frequency: Twice daily

Max: 300 mg/day

For idiopathic pulmonary fibrosis (IPF) and other progressive fibrosing ILDs and systemic sclerosis-ILD. Take with food to reduce GI side effects.

Paediatric dose

Route: N/A

Frequency: N/A

Max: Not licensed in children

No established paediatric dosing

Dose adjustments

Renal

No dose adjustment required in mild-moderate renal impairment

Hepatic

Contraindicated in moderate-severe hepatic impairment. Reduce to 100 mg BD in mild impairment.

Clinical pearls

INPULSIS trial: slows FVC decline in IPF by approximately 50% (−125.3 mL/year vs −187.8 mL/year)
Diarrhoea management key for adherence — start loperamide proactively with first dose if needed
Mandatory contraception for women of childbearing potential (teratogenic)
Monitor LFTs monthly for first 3 months, then 3-monthly

Contraindications

Moderate-severe hepatic impairment
Pregnancy
Active major bleeding

Side effects

Diarrhoea (62% — most common, often manageable with loperamide)
Nausea/vomiting
Abdominal pain
Liver enzyme elevation
Bleeding
Arterial thromboembolism
Hypothyroidism (rare)

Interactions

P-gp and CYP3A4 substrates — nintedanib is P-gp and CYP3A4 substrate
Anticoagulants — increased bleeding risk
Rifampicin — reduces nintedanib exposure
Ketoconazole — increases nintedanib levels

Monitoring

LFTs monthly (first 3 months), then 3-monthly
FVC every 6 months
Bleeding symptoms
GI symptoms and weight

Reference: BNFc; INPULSIS Trial (Richeldi et al, NEJM 2014); BNF; NICE TA379. Verify against your local formulary and the latest BNF before prescribing.

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways