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