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 (FDA) to ensure that
the benefits of a drug outweigh its risks. The FDA had required a REMS for ELIQUIS.
The goal of the ELIQUIS REMS is to inform healthcare providers (HCPs) about:
- the increased risk of thrombotic events when discontinuing ELIQUIS without an adequate alternative anticoagulant.
- the importance of following the recommendations in the US Prescribing Information (USPI) on how to convert patients with nonvalvular atrial fibrillation from ELIQUIS to warfarin or other anticoagulants.