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).
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
Superior reduction in major bleeding vs. well-managed warfarin2
Consistent efficacy and safety profile even when used with dose reduction2,3
Once-daily dosing with or without food1
Nonvalvular atrial fibrillation (NVAF)
Once-daily LIXIANA® was superior to warfarin in reducing the risk of major bleeding across a broad range of NVAF patients2*
Continue to know more about LIXIANA® for NVAF
LIXIANA® demonstrated superior reduction in major bleeding vs. well managed warfarin in ENGAGE AF-TIMI 48 study2*
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
FIND OUT MORELIXIANA® – simple and convenient once-daily dosing in NVAF1
60 mg Standard doseThe recommended dose of LIXIANA® is 60 mg in a once-daily tablet. 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.
30 mg Standard doseA dose of 30 mg once daily is required for certain patients with one or more of the clinical factors.
Renal function in NVAF
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.1
Clinical factors
A dose of 30 mg is recommended for patients with one or more of the following factors that increase risks of bleeding:1
Moderate or severe renal impairment (CrCl 15−50 ml/min)
Low body weight (≤60 kg)
Concomitant use of potent P-gp inhibitors (ciclosporin, dronedarone, erythromycin, or ketoconazole)
For more information on how to use LIXIANA® please download our practical guide
DOWNLOAD OUR PRACTICAL GUIDEFootnotes
* The primary safety endpoint of ENGAGE AF-TIMI 48 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.4
*** 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.1
CrCl, creatinine clearance; CYP, cytochrome P450; DOAC, direct oral anticoagulant; P-gp, P‑glycoprotein; VTE, venous thromboembolism.
Venous thromboembolism (VTE)
Once-daily LIXIANA® was superior to warfarin in reducing the risk of clinically relevant bleeding (the composite of major and clinically relevant nonmajor [CRNM] bleeding**) across a broad range of VTE patients
Continue to know more about LIXIANA® for VTE
LIXIANA® was superior to warfarin in reducing the risk of clinically relevant bleeding across a broad range of eligible VTE patients in Hokusai-VTE study3,**
In the safety-on-treatment population, the composite of major and clinically relevant nonmajor bleeding events with once-daily LIXIANA® vs. warfarin was: 8.5% vs. 10.3%3,**
HR 0.81; 95% CI, 0.71 to 0.91; p=0.004
Read about the Hokusai-VTE trial. The VTE—the largest single VTE (DVT and/or PE) trial to date.
FIND OUT MORELIXIANA® – simple and convenient once-daily dosing in VTE1
60 mg Standard doseThe recommended dose of LIXIANA® is 60 mg in a once-daily tablet. 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.
30 mg Standard doseA dose of 30 mg once daily is required for certain patients with one or more of the clinical factors.
Renal function in VTE
In patients with VTE, the duration of therapy for treatment of DVT and PE, and prevention of recurrent VTE should be individualised after careful assessment of the treatment benefit against the risk for bleeding. Short duration of therapy (at least 3 months) should be based on transient risk factors (e.g. recent surgery, trauma, immobilisation) and longer durations should be based on permanent risk factors or idiopathic DVT or PE.1
Clinical factors
A dose of 30 mg is recommended for patients with one or more of the following factors that increase risks of bleeding:1
Moderate or severe renal impairment (CrCl 15−50 ml/min)
Low body weight (≤60 kg)
Concomitant use of potent P-gp inhibitors (ciclosporin, dronedarone, erythromycin, or ketoconazole)
For more information on how to use LIXIANA® please download our practical guide
DOWNLOAD OUR PRACTICAL GUIDEFootnotes
* The primary safety endpoint of Hokusai- VTE was the incidence of adjudicated clinically relevant bleeding3, which was defined as a composite of major or clinically relevant nonmajor bleeding. Bleeding was defined as major if it was overt and was associated with a decrease in haemoglobin of 2 .0 g/dl or more or required a transfusion of 2 or more units of blood, occurred in a critical site, or contributed to death. Clinically relevant nonmajor bleeding was defined as overt bleeding that did not meet the criteria for major bleeding but was associated with the need for medical intervention, contact with a physician, or interruption of the study drug or with discomfort or impairment of activities of daily life.4
*** 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.1
CrCl, creatinine clearance; CYP, cytochrome P450; DOAC, direct oral anticoagulant; P-gp, P‑glycoprotein; VTE, venous thromboembolism.
