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Hepatic Injury Including Autoimmune Hepatitis and Other Immune-Medicated Disorders

Hepatic Injury Including Autoimmune Hepatitis

  • ZINBRYTA can cause severe liver injury including life-threatening events, liver failure, and autoimmune hepatitis. Obtain transaminase and bilirubin levels before initiation of ZINBRYTA. Monitor and evaluate transaminase and bilirubin levels monthly and up to 6 months after the last dose. 
  • ZINBRYTA is contraindicated in patients with pre-existing hepatic disease or hepatic impairment.

Other Immune-Mediated Disorders

  • Immune-mediated disorders including skin reactions, lymphadenopathy, non-infectious colitis, and other immune-mediated disorders can occur with ZINBRYTA.
  • These conditions may require treatment with systemic corticosteroids or immunosuppressive medication.

ZINBRYTA is available only through a restrict distribution program called the Zinbryta REMS Program.

Approved Risk Evaluation and Mitigation Strategies (REMS)

ZINBRYTA (Daclizumab) Injection

Patient Counseling Information

Medication Guides

Patient Medication Guide

Package Inserts


Updated January 2018