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COMMITTED TO PATIENT SAFETY...

XARELTO® establishing real-world outcomes
IMPORTANT SAFETY INFORMATION (cont’d)
Nursing Mothers: It is not known if rivaroxaban is
excreted in human milk.
Pediatric Use: Safety and effectiveness in pediatric
patients have not been established.
Females of Reproductive Potential: Females of
reproductive potential requiring anticoagulation
should discuss pregnancy planning with their physician.

ADVERSE REACTIONS IN CLINICAL STUDIES
The most common adverse reactions with
XARELTO® were bleeding complications.
Please see accompanying Brief Summary of full
Prescribing Information, including Boxed WARNINGS,
or visit www.XareltoHCP.com/PI.

038573-150812

USE IN SPECIFIC POPULATIONS (cont’d)

OVERDOSAGE
Discontinue XARELTO® and initiate appropriate
therapy if bleeding complications associated with
overdosage occur. A specific antidote for rivaroxaban
is not available. The use of activated charcoal to
reduce absorption in case of XARELTO® overdose
may be considered. Due to the high plasma protein
binding, rivaroxaban is not expected to be dialyzable.

References: 1. Data on file. Janssen Pharmaceuticals, Inc. Based on IMS Health, NPA Weekly, December 2015. 2. Beyer-Westendorf J, Förster K, Pannach S, et al. Rates,
management, and outcome of rivaroxaban bleeding in daily care: results from the Dresden NOAC registry. Blood. 2014;124(6):955-962. 3. Beyer-Westendorf J, Lützner J, Donath
L, et al. Efficacy and safety of thromboprophylaxis with low-molecular-weight heparin or rivaroxaban in hip and knee replacement surgery. Findings from the ORTHO-TEP registry.
Thromb Haemost. 2013;109(1):154-163. 4. Ogawa S, Ikeda T, Kitazono T, et al; on behalf of the Rivaroxaban Postmarketing Surveillance Registry Investigators. Present profiles of
novel anticoagulant use in Japanese patients with atrial fibrillation: insights from the rivaroxaban postmarketing surveillance registry. J Stroke Cerebrovasc Dis. 2014;23(10):25202526. 5. Laliberté F, Cloutier M, Nelson WW, et al. Real-world comparative effectiveness and safety of rivaroxaban and warfarin in nonvalvular atrial fibrillation patients.
Curr Med Res Opin. 2014;30(7):1317-1325. 6. Turpie AGG, Haas S, Kreutz R, et al. A non-interventional comparison of rivaroxaban with standard of care for thromboprophylaxis
after major orthopaedic surgery in 17,701 patients with propensity score adjustment. Thromb Haemost. 2014; 111(1):94-102. 7. Abraham NS, Singh S, Alexander CG, et al.
Comparative risk of gastrointestinal bleeding with dabigatran, rivaroxaban, and warfarin: population based cohort study. BMJ. 2015;350:h1857. 8. Chang H-Y, Zhou M,
Tang W, Alexander GC, Singh S. Risk of gastrointestinal bleeding associated with oral anticoagulants: population based retrospective cohort study. BMJ. 2015;350:h1585.
9. Lauffenburger JC, Farley JF, Gehi AK, Rhoney DH, Brookhart MA, Fang G. Factors driving anticoagulant selection in patients with atrial fibrillation in the United States.
Am J Cardiol. 2015;115(8):1095-1101. 10. Olesen JB, Sørensen R, Hansen ML, et al. Non-vitamin K antagonist oral anticoagulation agents in anticoagulant naïve atrial fibrillation
patients: Danish nationwide descriptive data 2011-2013. Europace. 2015;17(2):187-193. 11. Ageno W, Mantovani LG, Haas S, et al. Safety and effectiveness of oral rivaroxaban
versus standard anticoagulation for the treatment of symptomatic deep-vein thrombosis (XALIA): an international, prospective, non-interventional study. Lancet Haematol. 2016;
3(1):e12-e21. 12. Camm AJ, Amarenco P, Haas S, et al; on behalf of the XANTUS investigators. XANTUS: a real-world, prospective, observational study of patients treated with
rivaroxaban for stroke prevention in atrial fibrillation. Euro Heart J. 2015;1-9. 13. Tamayo S, Peacock WF, Patel M, et al. Characterizing major bleeding in patients with nonvalvular
atrial fibrillation: a pharmacovigilance study of 27,467 patients taking rivaroxaban. Clin Cardiol. 2015;38(2):63-68. 14. Patel MR, Mahaffey KW, Garg J, et al; and the ROCKET AF
Steering Committee, for the ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365(10):883-891.

XARELTO® is licensed from Bayer HealthCare AG, 51368 Leverkusen, Germany.
© Janssen Pharmaceuticals, Inc. 2016
March 2016
047166-160318

Janssen Pharmaceuticals, Inc.