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.
Adult dose
Dose adjustments
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 UKTreatment 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.