Daclizumab (drug discontinued 2019)

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.

Patient counseling

REMS

Medical guidelines

Package inserts

Keywords: Zinbryta
Updated: January 2023