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Stroke Prevention Pregnancy: Contraindicated — risk of foetal and neonatal haemorrhage; switch to LMWH in pregnancy; consult haematology

Edoxaban (Stroke Prevention)

Brand names: Lixiana

Adult dose

Dose: 60 mg once daily (standard); 30 mg once daily (if eGFR 15–50, body weight 60 kg or below, or concomitant P-gp inhibitor)
Route: Oral
Frequency: Once daily
Max: 60 mg/day
For AF-related stroke prevention. ENGAGE AF-TIMI 48 established edoxaban. Take at the same time each day with or without food. Once-daily dosing — single pill simplifies adherence vs warfarin.

Paediatric dose

Dose: Seek specialist opinion N/A/kg
Route: Oral
Frequency: N/A
Max: N/A
Not established for stroke prevention in paediatrics; seek specialist paediatric haematology or neurology opinion

Dose adjustments

Renal

eGFR 50–80 and above 80: 60 mg once daily. eGFR 15–50: 30 mg once daily. eGFR below 15: avoid — insufficient data and significant drug accumulation risk

Hepatic

Mild impairment: no adjustment. Moderate-severe impairment: avoid — increased bleeding risk due to coagulopathy

Paediatric weight-based calculator

Not established for stroke prevention in paediatrics; seek specialist paediatric haematology or neurology opinion

Clinical pearls

  • Mechanism: direct oral factor Xa inhibitor — reversibly inhibits factor Xa; no antithrombin III requirement; predictable pharmacokinetics; once-daily dosing due to longer half-life (10–14 hours)
  • ENGAGE AF-TIMI 48 (NEJM 2013): edoxaban 60 mg vs warfarin in AF — non-inferior for stroke/SE prevention; significantly lower major bleeding (20% relative reduction); significantly lower CV mortality and ICH
  • Neurological context: edoxaban 60 mg reduces AF-related cardioembolic stroke (most disabling stroke subtype); major advantage over warfarin for intracerebral haemorrhage risk (ICH 0.39% vs 0.85% per year)
  • Andexanet alfa (Ondexxya): reversal agent for factor Xa inhibitors (apixaban, rivaroxaban, edoxaban) — licensed in UK; use in life-threatening bleeding or emergency surgery; very expensive — use per local guidelines
  • MHRA: edoxaban licensed for AF stroke prevention and VTE treatment/prevention; NICE TA373 recommended for AF; dose reduction criteria must be checked at every prescription review
  • P-gp interaction: unique to edoxaban among NOACs — requires dose reduction to 30 mg with any P-gp inhibitor; check drug list at every review; dronedarone is a common cardiac drug P-gp inhibitor

Contraindications

  • Active clinically significant bleeding
  • Lesion or condition at significant risk of major bleeding
  • Hepatic impairment with coagulopathy
  • Mechanical prosthetic heart valves or moderate-severe mitral stenosis (NOACs contraindicated — warfarin only)
  • Pregnancy and breastfeeding

Side effects

  • Bleeding (most common — GI, urogenital, intracranial; ICH significantly less than warfarin)
  • Anaemia
  • Rash
  • Liver enzyme elevation
  • Nausea

Interactions

  • P-glycoprotein inhibitors (ciclosporin, dronedarone, erythromycin, ketoconazole) — increase edoxaban exposure; reduce dose to 30 mg
  • Rifampicin (strong P-gp inducer) — reduces edoxaban exposure significantly; avoid combination
  • Antiplatelet agents and NSAIDs (additive bleeding risk — monitor)

Monitoring

  • Renal function (annually or if acute illness — dose adjustment threshold)
  • Signs and symptoms of bleeding
  • LFTs at baseline
  • Body weight (dose adjustment if 60 kg or below)
  • Drug interactions review at every prescription (P-gp inhibitors)

Reference: BNFc; BNF 90; ENGAGE AF-TIMI 48 NEJM 2013;369(22):2093-2104; NICE TA373; MHRA SPC; ESC AF Guidelines 2020. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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