NOTE:
In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.
NOTE:
Alemtuzumab (Lemtrada) is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) program called the LEMTRADA REMS Program, because of the risks of autoimmunity, infusion reactions, and malignancies.
NOTE:
Alemtuzumab (Lemtrada) is not recommended for use in individuals with clinically isolated syndrome (CIS) due to its safety profile