Edoxaban (Stroke Prevention)

eMC §4.2 (Lixiana film-coated tablets). PREVENTION OF STROKE AND SYSTEMIC EMBOLISM in non-valvular atrial fibrillation: the recommended dose is 60 mg edoxaban once daily, continued long term. REDUCED DOSE — for both NVAF and VTE the recommended dose is 30 mg once daily in patients with one or more of: moderate or severe renal impairment (CrCl 15-50 mL/min); low body weight 60 kg or less; concomitant use of the P-glycoprotein inhibitors ciclosporin, dronedarone, erythromycin or ketoconazole. OTHER INDICATION — treatment of DVT, treatment of PE and prevention of recurrent VTE: 60 mg once daily following initial use of a parenteral anticoagulant for at least 5 days (edoxaban and the initial parenteral anticoagulant must not be given simultaneously); duration individualised, at least 3 months for transient risk factors and longer for permanent risk factors or idiopathic DVT/PE. MISSED DOSE: take the dose immediately and continue the following day with the once-daily intake; do not take double the prescribed dose on the same day. SWITCHING TO EDOXABAN: from a vitamin K antagonist — discontinue the VKA and start edoxaban when INR is 2.5 or less; from dabigatran, rivaroxaban or apixaban — start edoxaban at the time of the next dose of that anticoagulant; from a subcutaneous anticoagulant (LMWH, fondaparinux) — start edoxaban at the time of the next scheduled subcutaneous dose; from intravenous unfractionated heparin — discontinue the infusion and start edoxaban 4 hours later. SWITCHING FROM EDOXABAN TO A VKA (oral option): patients on 60 mg take 30 mg once daily together with an appropriate VKA dose, and patients on 30 mg take 15 mg once daily together with an appropriate VKA dose; no VKA loading dose; measure INR at least 3 times during the first 14 days, just prior to the daily edoxaban dose; discontinue edoxaban once INR is 2.0 or more (concomitant edoxaban and VKA can increase post-dose INR by up to 46%). ELDERLY: no dose reduction is required. RENAL FUNCTION must be assessed by calculating CrCl (Cockcroft-Gault) before initiation to exclude end-stage renal disease (CrCl below 15 mL/min) and again whenever a change in renal function is suspected. US LABELLING DIFFERENCE (cross-check only): the US label states edoxaban should NOT be used for NVAF in patients with CrCl greater than 95 mL/min, and gives 5 to 10 days of initial parenteral anticoagulant before starting for DVT/PE. The eMC posology text captured in this bundle is truncated part-way through the renal impairment paragraph and does not contain a paediatric posology — the clinician should read the full SPC §4.2.