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:
- the treatment of adult patients with Dupuytren's contracture with a palpable cord
- the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy
Each indication has separate REMS requirements and educational materials.
Follow the links below to learn more about the XIAFLEX REMS for each indication.