ZINBRYTA REMS Program
What is the ZINBRYTA (daclizumab) Risk Evaluation and Mitigation Strategy (REMS) Program?
A REMS is a strategy to manage known or potential serious risks associated with a drug product and is required by the FDA to ensure the benefits of a drug outweigh its risks. Due to the risks of severe liver injury, including life-threatening events, liver failure, and autoimmune hepatitis, and other immune-mediated disorders such as skin reactions, lymphadenopathy, and non-infectious colitis, ZINBRYTA is available only through a restricted program called the ZINBRYTA REMS Program.
*ZINBRYTA is not available to all pharmacies. If you have any questions about the ZINBRYTA REMS Program or need help enrolling, call 1-800-456-2255, Monday to Friday, 8:30 AM to 8:00 PM (ET).