Skip to main content

For US Healthcare Professionals

US Prescribing Information Medication Guide

NOW APPROVED WITH 2 INDICATIONS IN PEDIATRIC PATIENTS

Choose Adult IndicationDrugDrug name X

NVAF Reduce stroke risk
PAD Reduce the risk of major thrombotic vascular events
CAD Reduce the risk of major CV events
VTE Prophylaxis Acutely Ill Medical Patients
DVT/PE Initial treatment
DVT/PE Extended treatment
DVT Prophylaxis After hip/knee replacement surgery

Home
Clinical Trial
Efficacy Profile
Safety Profile
Dosing

Home
Clinical Trials
Efficacy
Safety
Net Clinical Benefit
Summary
Dosing

Home
Clinical Trials
Efficacy Profile
Safety Profile
Dosing

Home
Clinical Trials
Efficacy Profile
Safety Profile
Dosing

Home
Clinical Trial
Efficacy Profile
Safety Profile
Dosing

Home
Clinical Trials
Efficacy Profile
Safety Profile
Dosing

Home
Clinical Trial
Efficacy Profile
Safety Profile
Dosing

Adult Dosing
- NVAF
- CAD/PAD
- DVT/PE
Adult Switch and Management
Access and Support
Resources
- Resources Hub
- FAQs
Pediatric
- VTE (Pediatrics)
- Post Fontan (Pediatrics)

Important Safety Information
US Prescribing Information
Medication Guide
For Non-US Visitors
Patient Site
SEARCH

For

Choose Adult Indication

NVAFReduce stroke risk
PADReduce the risk of major thrombotic vascular events
CADReduce the risk of major CV events
VTE ProphylaxisAcutely Ill Medical Patients
DVT/PEInitial treatment
DVT/PEExtended treatment
DVT ProphylaxisAfter hip/knee replacement surgery

My patient can't afford XARELTO^®. Do you offer any resources to help him/her?

Janssen CarePath can help eligible patients find financial assistance options to help them pay for their XARELTO^® prescriptions.

Your patients can call 877-CarePath (877-227-3728) between 8:00 AM–8:00 PM ET, Monday to Friday, to talk with a Care Coordinator who will explain available options to them. Multilingual phone support is available.

If a patient does not have coverage for XARELTO^®, a comprehensive list of additional programs is available at JanssenPrescriptionAssistance.com.

People also ask…

Is there anyone who should not use XARELTO^®?
How do I switch patients from warfarin to XARELTO^®?
How do I switch patients from anticoagulants other than warfarin to XARELTO^®?

View all FAQs

^◇For VTE prophylaxis in acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding.

X

The 2023 ACC/AHA/ACCP/HRS Guideline Recommends XARELTO^® (rivaroxaban) as an Option for Eligible Patients With AF,* With No Age Limitations for Older Adults^¹

LEARN MORE

Use in Patients With Renal Impairment: Periodically assess renal function as clinically indicated (ie, more frequently in situations in which renal function may decline) and adjust therapy accordingly. Consider dose adjustment or discontinuation of XARELTO^® in patients who develop any renal failure while on XARELTO^®.²

Patients With End-Stage Renal Disease on Dialysis: Clinical efficacy and safety studies with XARELTO^® did not enroll patients with CrCl <30 mL/min or ESRD on dialysis. In patients with ESRD maintained on intermittent hemodialysis, administration of XARELTO^® 15 mg once daily will result in concentrations of rivaroxaban and pharmacodynamic activity similar to those observed in the ROCKET AF study. It is not known whether these concentrations will lead to similar stroke reduction and bleeding risk in patients with ESRD on dialysis, as was seen in ROCKET AF.²

*XARELTO^® is indicated to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. The use of XARELTO^® is not recommended in patients with prosthetic heart valves. While no longer using the "valvular" and "nonvalvular classifications of AF and concluding that those terms are obsolete, the 2023 Guideline for the Diagnosis and Management of Atrial Fibrillation notes that DOACs are currently recommended as first-line therapy over warfarin in patients with AF (except moderate to severe mitral stenosis or mechanical heart valve recipients).

ACC = American College of Cardiology; ACCP = American College of Clinical Pharmacy; AF = atrial fibrillation; AHA = American Heart Association; CrCl = creatinine clearance; DOAC = direct oral anticoagulant; ESRD = end-stage renal disease; HRS = Heart Rhythm Society; NVAF = nonvalvular atrial fibrillation.

References: 1. Joglar JA, Chung MK, Armbruster AL, et al. 2023 ACC/AHA/ACCP/HRS Guideline for the diagnosis and management of atrial fibrillation: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2024;83(1):109-279. 2. XARELTO^® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.

X

Do you want to leave XARELTOhcp.com?

By clicking on “Yes” below, you will leave XARELTOhcp.com.

Clicking on “Yes” below will take you to a website to which our site’s Privacy Policy does not apply. You are solely responsible for your interactions with that website. The links on XARELTOhcp.com are provided for informational purposes only and do not represent an endorsement, direct or implied, of the websites to which you will be directed.

YES NO

Dosing Across Indications
Legal Notice
Privacy Policy
Medical Information Center
Site Map

XARELTO^® is licensed from Bayer HealthCare AG, 51368 Leverkusen, Germany.

This site is published by Janssen Pharmaceuticals, Inc., which is solely responsible for its contents. This site is intended for use by healthcare professionals of the United States and Puerto Rico. Janssen Pharmaceuticals, Inc., recognizes that the Internet is a global communications medium; however, laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here may not be appropriate for use outside the United States and Puerto Rico.

Third party trademarks used herein are trademarks of their respective owners.

Legal Notice | Privacy Policy | Medical Information Center

Do not sell my personal information

Last Updated 01/24

Loading Common Footer...

Updated AF Guideline

X

2023 ACC/AHA/ACCP/HRS Guideline Recommends XARELTO^® as an Option for Eligible Patients with AF,^* With No Age Limitations for Older Adults^¹

LEARN MORE

*XARELTO^® is indicated to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. The use of XARELTO^® is not recommended in patients with prosthetic heart valves. While no longer using the "valvular" and "nonvalvular" classifications of AF and concluding that those terms are obsolete, the 2023 Guideline for the Diagnosis and Management of Atrial Fibrillation notes that DOACs are currently recommended as first-line therapy over warfarin in patients with AF (except moderate to severe mitral stenosis or mechanical heart valve recipients).

ACC = American College of Cardiology; ACCP = American College of Clinical Pharmacy; AF = atrial fibrillation; AHA = American Heart Association; DOAC = direct oral anticoagulant; HRS = Heart Rhythm Society; NVAF = nonvalvular atrial fibrillation.

Reference: 1. Joglar JA, Chung MK, Armbruster AL, et al. 2023 ACC/AHA/ACCP/HRS Guideline for the diagnosis and management of atrial fibrillation: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2024;83(1):109-279.

Need Help?

XARELTO^® HCP and Staff Assistance

X

REQUEST A MEDICAL SCIENCE LIAISON (MSL) Schedule time with an MSL

My patient can't afford XARELTO®. Do you offer any resources to help him/her?

People also ask…

My patient can't afford XARELTO^®. Do you offer any resources to help him/her?