XARELTO® (rivaroxaban) Risk Evaluation and Mitigation Strategy
A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration to ensure that the benefits of the drug outweigh its risks.
FDA has required a REMS for XARELTO® to communicate the risks of:
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
The REMS program materials are designed to inform healthcare providers (HCPs) and patients about the risks with XARELTO® and include a Dear Healthcare Professional Letter. It is important that you discuss with your patients the information included in the Medication Guide.
To learn more about the serious risks of XARELTO®, read the Important Safety Information provided in this link and use the links below to access REMS supporting materials:
For additional information, please call our Medical Information Center at 1-800-526-7736.