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

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LIXIANA® – 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.

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

Can be coadministered with other commonly used cardiovascular agents and proton pump inhibitors3

Lactose not listed as an excipient1***

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

DOWNLOAD OUR PRACTICAL GUIDE

Footnotes

* 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 MORE

LIXIANA® – 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.

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

Can be coadministered with other commonly used cardiovascular agents and proton pump inhibitors3

Lactose not listed as an excipient1***

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

DOWNLOAD OUR PRACTICAL GUIDE

Footnotes

* 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.