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Xarelto (rivaroxaban)

Company: Janssen Pharmaceuticals
Approval Status: Approved November 2011
Treatment for: stroke and systemic embolism resulting from atrial fibrillation
Areas: Cardiovascular / Cardiology
Possible similar drugs: Xarelto

| General Information | Clinical Results | Side Effects | Mechanism of Action | Literature References | Additional Information |


General Information

Xarelto (rivaroxaban) is an orally bioavailable factor Xa inhibitor that selectively blocks the active site of factor Xa and does not require a cofactor (such as Anti-thrombin III) for activity. Activation of factor X to factor Xa (FXa) via the intrinsic and extrinsic pathways plays a central role in the cascade of blood coagulation.

Xarelto is specifically indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

Xarelto is supplied as a tablet for oral administration. The recommended dose for patients with creatinine clearance (CrCl) >50 mL/min, is 20 mg taken orally once daily with the evening meal. For patients with CrCl 15 to 50 mL/min, the recommended dose is 15 mg once daily with the evening meal.


Clinical Results

FDA Approval
The FDA approval of Xarelto for the reducuction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation was based on a multi-national, double-blind, non-inferiority study. This study, ROCKET AF, enrolled 14,264 subjects with nonvalvular atrial fibrillation. The subjects received Xarelto (at a dose of 20 mg once daily with the evening meal in patients with CrCl >50 mL/min and 15 mg once daily with the evening meal in patients with CrCl 30 to <50 mL/min) or warfarin (titrated to INR 2.0 to 3.0), the standard of care. The median treatment duration was 590 days.The trial was designed to demonstrate that Xarelto preserved more than 50% of warfarin’s effect on stroke and non-CNS systemic embolism. Xarelto demonstrated non-inferiority to warfarin for the primary composite endpoint of time to first occurrence of stroke (any type) or non-CNS systemic embolism, but superiority to warfarin was not demonstrated.


Side Effects

The most common adverse event associated with the use of Xarelto for the reducuction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation is bleeding.


Mechanism of Action

Xarelto (rivaroxaban) is an orally bioavailable factor Xa inhibitor that selectively blocks the active site of factor Xa and does not require a cofactor (such as Anti-thrombin III) for activity. Activation of factor X to factor Xa (FXa) via the intrinsic and extrinsic pathways plays a central role in the cascade of blood coagulation.


Literature References

Fox KA, Piccini JP, Wojdyla D, Becker RC, Halperin JL, Nessel CC, Paolini JF, Hankey GJ, Mahaffey KW, Patel MR, Singer DE, Califf RM Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in patients with non-valvular atrial fibrillation and moderate renal impairment. European Heart Journal 2011 Oct;32(19):2387-94

Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM; ROCKET AF Investigators Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. New England Journal of Medicine 2011 Sep 8;365(10):883-91


Additional Information

For additional information regarding Xarelto or the reduction in the risk of stroke and systemic embolism due to nonvalvular atrial fibrillation, please visit the Xarelto web page.




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Xarelto Drug Information

The Xarelto drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.





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