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Tyrosine Kinase Inhibitor — Anti-fibrotic Pregnancy: Contraindicated — embryo-foetotoxic in animal studies; effective contraception during and for ≥3 months after stopping

Nintedanib (SSc-ILD)

Brand names: Ofev

Adult dose

Dose: 150 mg twice daily with food
Route: Oral
Frequency: Twice daily
Max: 300 mg/day
Take with food — reduces GI side effects. If diarrhoea develops: loperamide first-line; reduce dose to 100 mg BD if grade 2 toxicity persists; stop if grade 3. Dose reduction to 100 mg BD permitted if tolerability issues. Used for systemic sclerosis-associated interstitial lung disease (SSc-ILD) and idiopathic pulmonary fibrosis (IPF).

Paediatric dose

Route:
Not licensed for paediatric use — seek specialist opinion

Dose adjustments

Renal

No dose adjustment required for mild-moderate renal impairment; caution in severe renal impairment (limited data)

Hepatic

Mild hepatic impairment (Child-Pugh A): no adjustment required. Moderate (Child-Pugh B): reduce to 100 mg BD. Severe (Child-Pugh C): avoid

Clinical pearls

  • SENSCIS trial (NEJM 2019): nintedanib 150 mg BD reduced the rate of decline of FVC by 41% compared to placebo in SSc-ILD — the first trial to demonstrate pharmacological slowing of lung function decline in SSc-ILD
  • Diarrhoea management is key to treatment success: proactive loperamide prescription at initiation; dietary advice (low fat, low fibre); if severe, dose reduce to 100 mg BD before considering cessation
  • SSc-ILD screening: HRCT and pulmonary function tests (spirometry + DLCO) are standard in SSc — DLCO <70% and/or FVC <80% with ILD pattern = indication to consider nintedanib
  • Peanut/soya allergy: nintedanib capsules contain soya lecithin — contraindicated in soya or peanut allergy; check allergy history before prescribing
  • MHRA approved for SSc-ILD in UK based on SENSCIS data; also licensed for IPF (different patient population — avoid prescribing nintedanib intended for IPF to SSc patients without confirming dose and indication)

Contraindications

  • Pregnancy — embryo-foetotoxic
  • Severe hepatic impairment (Child-Pugh C)
  • Hypersensitivity to nintedanib or excipients (groundnut/soya oil excipient — peanut allergy)
  • Concurrent pirfenidone (same mechanism area — no evidence for combination)

Side effects

  • Diarrhoea — most common (>60%); usually manageable with loperamide
  • Nausea and vomiting
  • Elevated liver enzymes (ALT/AST) — potentially hepatotoxic; LFT monitoring required
  • Bleeding — increased risk due to VEGFR inhibition; caution in anticoagulated patients
  • Arterial thromboembolic events (myocardial infarction) — VEGFR2 inhibition
  • Hypertension

Interactions

  • P-gp and CYP3A4 inhibitors (ketoconazole, erythromycin) — increase nintedanib exposure; monitor for increased toxicity
  • P-gp and CYP3A4 inducers (rifampicin, carbamazepine) — reduce nintedanib levels; therapeutic failure risk
  • Anticoagulants — increased bleeding risk with warfarin or DOACs; monitor INR if on warfarin

Monitoring

  • LFTs at baseline, monthly for first 3 months, then 3-monthly
  • FVC (spirometry) at baseline and every 6 months
  • Blood pressure
  • GI symptoms — diarrhoea management
  • Signs of bleeding (platelet count, INR if on warfarin)

Reference: BNFc; BNF 90; NICE TA751 (Nintedanib SSc-ILD); SENSCIS Trial (NEJM 2019); MHRA Approval (Ofev SSc-ILD); SPC Ofev. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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