Risk Evaluation and Mitigation Strategies (REMS) Summary

Goals of the Zinbryta (daclizumab) REMS Program

To mitigate the risks of severe and fatal hepatic injury and serious immune-mediated disorders associated with ZINBRYTA by:

• Ensuring that prescribers are educated on the following:
- the potential risks of severe and fatal hepatic injury and serious immune-mediated disorders associated with the use of ZINBRYTA
- the need to counsel patients about these risks and the need for appropriate baseline and monthly monitoring
• Ensuring that prescribers are educated on and adhere to:
- required baseline and monthly monitoring and evaluation of patients who receive ZINBRYTA
• Ensuring that patients are informed about:
- the potential risks of severe and fatal hepatic injury and serious immune-mediated disorders associated with the use of ZINBRYTA
- appropriate baseline and monthly monitoring
• Enrollment of all patients in a registry to further support long-term safety and safe use of ZINBRYTA

REMS Elements

• Communication Plan

• Elements to Assure Safe Use

• Implementation System

Open the Full REMS Notification

REMS Summary of Terms