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Direct Factor Xa Inhibitor (DOAC) Pregnancy: Contraindicated during pregnancy and breast-feeding. Women of childbearing potential should avoid becoming pregnant during treatment.

Edoxaban (AF Stroke Prevention / VTE)

Brand names: Lixiana, Savaysa (US)

Edoxaban is a direct oral anticoagulant (a factor Xa inhibitor) used for stroke prevention in atrial fibrillation and for the treatment and prevention of venous thromboembolism.

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: 60 mg once daily; reduce to 30 mg once daily if any of: moderate or severe renal impairment (CrCl 15-50 mL/min), body weight 60 kg or less, or concomitant ciclosporin, dronedarone, erythromycin or ketoconazole
Route: Oral
Frequency: Once daily
Same 60 mg once-daily dose for prevention of stroke and systemic embolism in NVAF (continue long term) and for treatment of DVT/PE and prevention of recurrent VTE. For VTE, edoxaban follows initial use of a parenteral anticoagulant for at least 5 days — edoxaban and the initial parenteral anticoagulant must not be given simultaneously. VTE treatment duration should be individualised: at least 3 months where risk factors are transient (recent surgery, trauma, immobilisation), longer for permanent risk factors or idiopathic DVT/PE. Elderly: no dose reduction is required, but co-administration with acetylsalicylic acid in elderly patients should be used cautiously because of a potentially higher bleeding risk. Missed dose: take immediately and continue once daily the following day; do not double the dose. Switching from a VKA: discontinue the VKA and start edoxaban when INR is 2.5 or below; from unfractionated heparin infusion: stop the infusion and start edoxaban 4 hours later. The 15 mg strength is not indicated as monotherapy — it is only for switching from edoxaban 30 mg to a VKA (patients on 60 mg switch via 30 mg once daily with an appropriate VKA dose). Hepatic impairment: not recommended in severe hepatic impairment. No specific reversal agent is available and haemodialysis does not significantly contribute to edoxaban clearance.

Dose adjustments

Renal

Assess CrCl (Cockcroft-Gault) before starting. CrCl >50-80 mL/min: 60 mg once daily. CrCl 15-50 mL/min: 30 mg once daily. Not for use in end stage renal disease (CrCl <15 mL/min) or on dialysis. Use in NVAF with high CrCl only after careful evaluation of individual thromboembolic and bleeding risk (US label: do not use if CrCl >95 mL/min). Reassess renal function when a change is suspected.

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.

US labelling (FDA)

Reference — US labelling, may differ from UK

Treatment of NVAF: Assess CrCL before initiating therapy ( 2.1 ) The recommended dose is 60 mg once daily in patients with CrCL >50 to ≤ 95 mL/min. Do not use SAVAYSA in patients with CrCL > 95 mL/min ( 2.1 ) Reduce dose to 30 mg once daily in patients with creatinine clearance 15 to 50 mL/min ( 2.1 ) Treatment of DVT and PE: The recommended dose is 60 mg once daily ( 2.2 ) Reduce dose to 30 mg once daily for patients with CrCL 15 to 50 mL/min or body weight less than or equal to 60 kg or who use certain P-gp inhibitors ( 2.2 ) 2.1 Nonvalvular Atrial Fibrillation The recommended dose of SAVAYSA is 60 mg taken orally once daily [see Warnings and Precautions (5.1) and Clinical Studies (14.1) …

Source: US FDA prescribing information (openFDA / DailyMed), label dated 2025-07-10. Accessed 2026-06-12. US dosing and indications can differ from UK practice — use UK sources for prescribing decisions.

Contraindications

  • Hypersensitivity to edoxaban or any excipient
  • Clinically significant active bleeding
  • Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
  • Lesion or condition considered a significant risk for major bleeding (e.g. current/recent GI ulceration, malignancy at high bleeding risk, recent brain/spinal injury or surgery, recent intracranial haemorrhage, oesophageal varices, arteriovenous malformations, vascular aneurysms)
  • Uncontrolled severe hypertension
  • Concomitant treatment with any other anticoagulant (UFH, LMWH, heparin derivatives, warfarin, dabigatran, rivaroxaban, apixaban), except when switching or when UFH is used to keep a central venous or arterial catheter open
  • Pregnancy and breast-feeding

Side effects

  • Epistaxis (7.7%)
  • Macroscopic haematuria/urethral haemorrhage (6.9%)
  • Anaemia (5.3%)
  • Upper and lower gastrointestinal haemorrhage, oral/pharyngeal haemorrhage, abdominal pain and nausea
  • Rash and pruritus; abnormal liver function tests (raised bilirubin, GGT)

Interactions

  • P-glycoprotein inhibitors — ciclosporin, dronedarone, erythromycin or ketoconazole require the reduced 30 mg once-daily dose
  • Other anticoagulants — contraindicated concomitantly except during defined switching
  • Antiplatelet drugs, aspirin, NSAIDs, thrombolytics and SSRIs/SNRIs increase bleeding risk; monitor closely
  • Acetylsalicylic acid in elderly patients — use cautiously (higher bleeding risk)

Clinical monograph

How it works

It directly and reversibly inhibits activated factor Xa, reducing thrombin generation and clot formation.

Prescribing in practice

  • Bleeding is the main risk; assess bleeding and thrombotic risk, and the dose depends on renal function and body weight.
  • In atrial fibrillation, efficacy may be reduced in patients with high creatinine clearance, which is a labelled caution when choosing therapy.
  • It is taken once daily and does not require routine anticoagulant monitoring.

Monitoring

Monitor renal function, full blood count and for signs of bleeding; reassess if renal function or weight changes.

Counselling the patient

  • Report unusual bruising or bleeding, black stools or blood in the urine.
  • Do not stop the medicine without advice, and tell other clinicians and dentists you take an anticoagulant.

Evidence & guidelines

Non-inferior to warfarin for stroke prevention in atrial fibrillation (ENGAGE AF-TIMI 48) and recommended in UK guidance (NICE NG196).

Reference: ENGAGE-AF TIMI 48 (Giugliano et al. NEJM 2013); NICE NG196 (AF); MHRA SPC Lixiana; NICE NG185 (VTE); 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).

Related

Curated clinical cross-links plus same-class fallbacks.