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XIAFLEX REMS (Risk Evaluation and Mitigation Strategy)

A REMS is a strategy to manage known or potential serious risks associated with a drug and is required by the Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks. Auxilium has worked with the FDA to develop materials to communicate to healthcare providers and patients, the potential serious risks associated with use of XIAFLEX.

XIAFLEX is approved for two indications:

Each indication has separate REMS requirements and educational materials.

Follow the links below to learn more about the XIAFLEX REMS for each indication.