Edoxaban (AF / VTE)

REDUCED DOSE — 30 mg edoxaban once daily is recommended, for both NVAF and VTE, in patients with one or more of the following: moderate or severe renal impairment (creatinine clearance 15-50 mL/min); low body weight 60 kg or less; concomitant use of the P-glycoprotein inhibitors ciclosporin, dronedarone, erythromycin or ketoconazole. DURATION: NVAF therapy should be continued long term. For DVT/PE the duration should be individualised — at least 3 months for transient risk factors (recent surgery, trauma, immobilisation), longer for permanent risk factors or idiopathic DVT/PE. Edoxaban and the initial parenteral anticoagulant must NOT be given simultaneously. 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 the INR is 2.5 or less; from dabigatran/rivaroxaban/apixaban — discontinue and start edoxaban at the time of the next scheduled dose; from subcutaneous LMWH or 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; patients on 30 mg take 15 mg once daily together with an appropriate VKA dose; no VKA loading dose; discontinue edoxaban once the INR is 2.0 or above (after 14 days discontinue edoxaban and continue titrating the VKA to INR 2-3). CARDIOVERSION: edoxaban can be initiated or continued; for TOE-guided cardioversion in anticoagulant-naive patients start at least 2 hours before cardioversion, and perform cardioversion no later than 12 hours after the dose on the day of the procedure. NVAF WITH HIGH CrCl: a trend towards decreasing efficacy with increasing CrCl was observed versus well-managed warfarin — use in patients with NVAF and high CrCl only after careful evaluation of individual thromboembolic and bleeding risk (the US label states edoxaban should not be used in NVAF with CrCl above 95 mL/min). HEPATIC: contraindicated in hepatic disease associated with coagulopathy and clinically relevant bleeding risk; not recommended in severe hepatic impairment; mild to moderate hepatic impairment 60 mg once daily, with caution; perform liver function testing before initiating. ELDERLY and GENDER: no dose reduction required. PAEDIATRIC: edoxaban is not recommended for use in children and adolescents from birth to 18 years with confirmed VTE, as efficacy has not been established. NO REVERSAL AGENT: a specific anticoagulant reversal agent for edoxaban is not available, and the anticoagulant effect cannot be reliably monitored with standard laboratory testing. PROVENANCE NOTE: the fetched eMC record is 'Lixiana 15mg Film-Coated Tablets', but the section 4.2 text retrieved is the full Lixiana posology covering the 60/30/15 mg strengths and literally states 'The recommended dose is 60 mg edoxaban once daily'. Section 4.4 of that same SPC warns that 'Edoxaban 15 mg is not indicated as monotherapy, as it may result in decreased efficacy' — the 15 mg strength is only for the step-down when switching from 30 mg edoxaban to a VKA. Confirm the headline dose against the 60 mg SPC record.