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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 and fatal liver injury, including autoimmune hepatitis and liver failure, and other immune-mediated disorders such as skin reactions, lymphadenopathy, immune-mediated colitis, and other serious conditions, 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.

Indication

ZINBRYTA is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of ZINBRYTA should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.

Please see Prescribing Information, including BOXED WARNING, for additional information.