Your choice for ageing
patients with NVAF

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What is LIXIANA® indicated for?

LIXIANA® is indicated for:1 prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA)

Superior reduction
in major bleeding

vs. well-managed warfarin2

Efficacy and safety profile

even when used with appropriate dose reduction2

Once-daily dosing with or without food

in NVAF1

In patients with NVAF and high CrCl, there is a trend towards decreasing efficacy with increasing CrCl for edoxaban vs well-managed warfarin, therefore careful evaluation of thromboembolic and bleeding risk is necessary before initiation.

LIXIANA® demonstrated superior reduction in major bleeding vs. well-managed warfarin2*

In the safety-on-treatment population

the annualised rate of major bleeding events with once-daily LIXIANA® vs. well-controlled warfarin was: 2.75% vs 3.43%2*

HR 0.80; 95% CI, 0.71 to 0.91; P<0.001

Read about the ENGAGE AF-TIMI 48 trial. The longest DOAC trial to date in NVAF

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Real-world evidence reinforces LIXIANA® as your DOAC of choice for ageing patients with NVAF3,4

Data from a 1-year snapshot analysis of an ongoing observational study in 12,574 patients with NVAF (ETNA-AF** Europe),1 treated with once-daily LIXIANA® (edoxaban), reinforced the findings of the pivotal phase 3 study (ENGAGE-AF† European Cohort).2,4

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LIXIANA® – simple and convenient once-daily dosing in NVAF5

60mg Standard dose

The recommended dose of LIXIANA® is 60 mg once-daily. It can be taken with water, with or without food. To aid compliance, patients should be encouraged to take their dose at the same time every day.

30mg Reduced dose

A dose of 30 mg once daily is required for certain patients who fall into specific sub-groups.

Recommended for patients with one or more of the following factors that increase risks of bleeding:1

Renal impairment
(CrCl 15−50 ml/min)

Low body weight
(≤60 kg)

Concomitant use of potent P-gp inhibitors
(dronedarone, erythromycin, ketoconazole, ciclosporin)

Can be taken with or without food1

Not significantly affected by CYP450 inducers/inhibitors
(<10% is metabolised by CYP3A4/5)1

Rapid onset of anticoagulant therapeutic effect
(1-2 hours)1

No routine anticoagulation level monitoring required1

Lactose not listed as an excipient5††

In patients with NVAF and high CrCl, there is a trend towards decreasing efficacy with increasing CrCl for edoxaban vs well-managed warfarin, therefore careful evaluation of thromboembolic and bleeding risk is necessary before initiation.

For more information on how to use LIXIANA® please download our practical guide

Download our practical guide
Footnotes

* The primary safety endpoint was the incidence of adjudicated major bleeding2, defined by the International Society of Thrombosis and Haemostasis (ISTH) as (i) fatal bleeding; and/or (ii) symptomatic bleeding in critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, pericardial, or intramuscular with compartment syndrome, and/or (iii) bleeding causing a fall in haemoglobin level of 2.0 g/dl or more, or leading to transfusion of two or more units of whole blood or red cells.6

**ETNA-AF (Edoxaban Treatment in Routine Clinical Practice for Patients With Nonvalvular Atrial Fibrillation)

†ENGAGE-AF (Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation)

†† We cannot guarantee that there has been no contact with lactose during manufacture. Use with caution in patients that have had severe anaphylaxis with lactose products.3

CrCl, creatinine clearance; CYP, cytochrome P450; DOAC, direct oral anticoagulant; P-gp, P‑glycoprotein; VTE, venous thromboembolism.