Tyrosine Kinase Inhibitor — Anti-fibrotic Pregnancy: Contraindicated during pregnancy — nintedanib may cause foetal harm in humans and pre-clinical animal studies have shown reproductive toxicity. Women of childbearing potential should be advised to avoid becoming pregnant and to use highly effective contraceptive methods at initiation of, during, and for at least 3 months after the last dose. Pregnancy testing must be conducted prior to treatment and during treatment as appropriate. If a patient becomes pregnant while receiving nintedanib, treatment must be discontinued and she should be apprised of the potential hazard to the foetus.

Nintedanib (SSc-ILD)

Brand names: Ofev

Nintedanib is an oral antifibrotic tyrosine kinase inhibitor used in rheumatology to slow lung function decline in systemic sclerosis-associated interstitial lung disease and in other progressive fibrosing interstitial lung diseases.

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 — capsules taken with food, swallowed whole with water; they should not be chewed, opened or crushed

Frequency: Twice daily, administered approximately 12 hours apart

Max: 300 mg daily — the recommended maximum daily dose should not be exceeded

Fetched UK SPC: Nintedanib 100 mg Soft Capsule (eMC product 102144). Treatment should be initiated by physicians experienced in the management of the diseases for which nintedanib soft capsules are approved (the §4.8 adverse reaction table covers idiopathic pulmonary fibrosis, other chronic fibrosing ILDs with a progressive phenotype, and systemic sclerosis associated interstitial lung disease). The 100 mg twice daily dose is only recommended for patients who do not tolerate the 150 mg twice daily dose. Management of adverse reactions may include dose reduction and temporary interruption until the reaction has resolved to a level allowing continuation; treatment may then be resumed at the full dose (150 mg twice daily) or a reduced dose (100 mg twice daily). If an adult patient does not tolerate 100 mg twice daily, nintedanib should be discontinued. If diarrhoea, nausea and/or vomiting persist despite appropriate supportive care (including anti-emetic therapy), dose reduction or treatment interruption may be required; in case of persisting severe diarrhoea, nausea and/or vomiting despite symptomatic treatment, therapy should be discontinued. After interruption for AST or ALT elevations greater than 3 times the upper limit of normal, once transaminases have returned to baseline treatment may be reintroduced at 100 mg twice daily and subsequently increased to 150 mg twice daily. Missed dose: administration should resume at the next scheduled time at the recommended dose — the patient should not take an additional dose. Hepatic impairment: in adults with mild hepatic impairment (Child-Pugh A) the recommended dose is 100 mg twice daily approximately 12 hours apart, and treatment interruption or discontinuation for management of adverse reactions should be considered; treatment of patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment is not recommended. Elderly: no a-priori dose adjustment is required, but patients aged 75 years and over may be more likely to require dose reduction to manage adverse effects. Paediatric (no per-kg dose is stated, so paedDose is null): the SPC states nintedanib should not be used in children. Verify any under-18 use against a children's formulary.

Dose adjustments

Renal

Adjustment of the starting dose in patients with mild to moderate renal impairment is not required. The safety, efficacy and pharmacokinetics of nintedanib have not been studied in patients with severe renal impairment (creatinine clearance below 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, nausea, abdominal pain and vomiting (very common in SSc-ILD)
Hepatic enzyme increased (very common); ALT, AST, GGT and alkaline phosphatase increased; drug induced liver injury (uncommon)
Weight decreased and decreased appetite (common)
Bleeding (common) and hypertension (common)
Headache (common)
Renal failure (uncommon in SSc-ILD); colitis (uncommon); thrombocytopenia (uncommon); pruritus (uncommon)

Interactions

P-glycoprotein and CYP3A4 inhibitors (e.g. ketoconazole, erythromycin) — may increase nintedanib exposure (ketoconazole increased exposure by 60%); monitor closely for tolerability, and interruption, dose reduction or discontinuation may be required (US labelling §7.1)
P-glycoprotein and CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenytoin, St John's wort) — decrease nintedanib exposure (rifampicin decreased exposure by 50%); concomitant use should be avoided (US labelling §7.1)
Anticoagulants — nintedanib is a VEGFR inhibitor and may increase the risk of bleeding; monitor patients on full anticoagulation therapy closely for bleeding (US labelling §7.2)
Oral hormonal contraceptives — nintedanib does not relevantly affect ethinylestradiol or levonorgestrel exposure, but their efficacy may be compromised by vomiting and/or diarrhoea, so an alternative highly effective contraceptive measure should be used if these occur (§4.6)

Clinical monograph

How it works

It inhibits multiple tyrosine kinases including the platelet-derived, fibroblast and vascular endothelial growth factor receptors, attenuating fibroblast proliferation and the fibrotic processes that drive progressive lung scarring.

Prescribing in practice

Diarrhoea is very common and can be severe enough to cause dehydration, so manage it promptly with hydration and antidiarrhoeals and adjust the dose as directed rather than stopping abruptly.
It can cause hepatotoxicity, and because of its antiangiogenic action it raises the risk of bleeding, impaired wound healing and rare gastrointestinal perforation.
It is teratogenic, so effective contraception is required for people of childbearing potential and it should be taken with food.

Monitoring

Monitor liver function before and during treatment and watch for gastrointestinal effects, bleeding and signs of dehydration.

Counselling the patient

Take capsules with food and report troublesome diarrhoea early so it can be managed.
Report yellowing of the skin, unusual bleeding or severe abdominal pain.
Use effective contraception and tell the team before any planned surgery.

Evidence & guidelines

Nintedanib is approved and NICE-appraised for systemic sclerosis-associated and other progressive fibrosing interstitial lung diseases on the basis of trials showing reduced lung function decline.

Reference: NICE TA751 (Nintedanib SSc-ILD); SENSCIS Trial (NEJM 2019); MHRA Approval (Ofev SSc-ILD); SPC Ofev; 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