Drug Safety Warnings and Updates: July-September 2017

Teresa Rubio, PharmD


January 03, 2018

Editorial Collaboration

Medscape &

In This Article

Daclizumab (ZINBRYTA®)

For more on this Drug Safety Labeling Change, click here.

For full prescribing information, click here.

Updated Boxed Warning

Hepatic Injury Including Autoimmune Hepatitis

  • ZINBRYTA can cause severe liver injury, including autoimmune hepatitis and liver failure. Fatal cases have occurred. Liver injury, including autoimmune hepatitis and acute liver failure, can occur at any time during treatment with ZINBRYTA, with cases reported up to 5 months after the last dose of ZINBRYTA.

Other Immune-Mediated Disorders

  • In addition to autoimmune hepatitis, a variety of immune-mediated disorders, including skin reactions, lymphadenopathy, non-infectious colitis, and other serious conditions, can occur in patients treated with ZINBRYTA. Overall, serious immune-mediated disorders were observed in 5% of patients treated with ZINBRYTA.