Antifibrotic (Tyrosine Kinase Inhibitor) Pregnancy: Contraindicated in pregnancy - may cause foetal harm. Pregnancy testing must be conducted before and, as appropriate, during treatment; women of childbearing potential must use highly effective contraception during and for at least 3 months after the last dose. Breast-feeding should be discontinued during treatment.

Nintedanib

Brand names: Ofev

Nintedanib is an oral tyrosine kinase inhibitor used to treat idiopathic pulmonary fibrosis and other chronic fibrosing interstitial lung diseases with a progressive phenotype, including systemic sclerosis-associated interstitial lung disease.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 150 mg

Route: Oral (soft capsules, taken with food, swallowed whole with water - not chewed, opened or crushed)

Frequency: Twice daily, approximately 12 hours apart

Max: 300 mg daily (the recommended maximum daily dose of 300 mg should not be exceeded)

Treatment should be initiated by physicians experienced in the management of the approved indications. The 100 mg twice daily dose is only recommended for patients who do not tolerate 150 mg twice daily; if a patient does not tolerate 100 mg twice daily, treatment should be discontinued. Management of adverse reactions may require dose reduction (100 mg twice daily) or temporary interruption; after interruption for AST/ALT elevations >3x ULN, treatment may be reintroduced at 100 mg twice daily once transaminases return to baseline and then increased to 150 mg twice daily. Mild hepatic impairment (Child Pugh A): recommended dose 100 mg twice daily; not recommended in Child Pugh B or C. Elderly: no a-priori dose adjustment, but patients 75 years and over may be more likely to need dose reduction. Missed dose: resume at the next scheduled time at the recommended dose - do not take an additional dose. Paediatric: the SPC states nintedanib should not be used in children. Interactions listed below are taken from the US FDA label section 7 because SPC section 4.5 was not captured in this bundle; eMC sections 4.4 and 4.8 were truncated at the source-fetch limit, so the drafted lists may be incomplete.

Dose adjustments

Renal

Adjustment of the starting dose in mild to moderate renal impairment is not required. Safety, efficacy and pharmacokinetics have not been studied in severe renal impairment (creatinine clearance < 30 ml/min).

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Pregnancy
Hypersensitivity to nintedanib, to peanut or soya, or to any of the excipients

Side effects

Diarrhoea (very common)
Nausea and vomiting (very common)
Abdominal pain (very common)
Hepatic enzyme increased (very common)
Decreased appetite and weight decreased (common)
Bleeding and drug-induced liver injury

Interactions

P-gp and CYP3A4 inhibitors (e.g. ketoconazole, erythromycin) may increase nintedanib exposure - monitor closely for tolerability (US label section 7.1)
P-gp and CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenytoin, St John's wort) decrease exposure and should be avoided (US label section 7.1)
Anticoagulants: nintedanib is a VEGFR inhibitor and may increase bleeding risk - monitor patients on full anticoagulation closely (US label section 7.2)
Oral hormonal contraceptive efficacy may be compromised by vomiting and/or diarrhoea - an alternative highly effective method should be used (SPC section 4.6)

Clinical monograph

How it works

It inhibits receptor tyrosine kinases including those for vascular endothelial growth factor, fibroblast growth factor and platelet-derived growth factor, slowing the fibroproliferative processes that drive lung fibrosis.

Prescribing in practice

Hepatotoxicity can occur, so liver function must be checked before treatment and monitored during therapy, with dose modification or interruption for significant derangement.
Diarrhoea is very common and should be managed promptly with hydration and antidiarrhoeal measures to maintain treatment.
It is contraindicated in pregnancy and carries a bleeding and gastrointestinal perforation risk; use caution with anticoagulants and recent surgery.

Monitoring

Check liver function before starting and periodically thereafter, and monitor for diarrhoea, weight loss and bleeding.

Counselling the patient

Take the capsules with food and report persistent diarrhoea, vomiting or abdominal pain.
Effective contraception is essential as this medicine can harm an unborn baby.
Report yellowing of the skin or eyes, dark urine or unusual bruising or bleeding.

Evidence & guidelines

Pivotal trials (INPULSIS and the SENSCIS study) demonstrated that nintedanib slows decline in forced vital capacity, supporting NICE-recommended use in fibrosing lung disease.

Reference: INPULSIS Trial (Richeldi et al, NEJM 2014); NICE TA379; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways