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.
Notable requirements of the LEMTRADA REMS Program include the following:
- Prescribers must be certified with the program, by enrolling and completing training.
- Patients must enroll in the program and comply with ongoing monitoring requirements.
- Pharmacies must be certified with the program and must only dispense to certified healthcare facilities that are authorized to receive alemtuzumab (Lemtrada).
- Healthcare facilities must enroll in the program and verify that patients are authorized before infusing alemtuzumab (Lemtrada). Healthcare facilities must have on-site access to equipment and personnel trained to manage infusion reactions.
NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.