A REMS (Risk Evaluation and Mitigation Strategy) is a program required by the Food and Drug Administration (FDA) to manage known or potential serious risks associated with a drug product
ULTOMIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS).
HCPs who prescribe ULTOMIRIS must be specifically certified. Certification consists of review of REMS educational materials and enrollment in the ULTOMIRIS REMS program.
HCPs should report all suspected adverse events, including reports of meningococcal infection by contacting Alexion Pharmaceuticals, Inc. at 1-888-765-4747 or reporting the information to the FDA MedWatch Reporting System by phone at 1.800.FDA.1088 (1.800.332.1088) or by mail using Form 3500 at http://www.fda.gov/MedWatch