Dear The Association of Black Cardiologists,
The FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS), which consists of a Medication Guide and a Communication Plan, is necessary to ensure that the benefits of XARELTO® (rivaroxaban) outweigh the potential risks to patients with nonvalvular atrial fibrillation, including:
- Increased risk of thrombotic events, including stroke, if XARELTO® is discontinued without introducing an adequate alternative anticoagulant
- Potential decreased efficacy of XARELTO®; (15 mg and 20 mg) if not taken with the evening meal Janssen Pharmaceuticals, Inc., respectfully requests that you disseminate REMS materials to your membership and also post this information to your organization’s website.
National Advocacy Director
Janssen Pharmaceuticals, Inc.©