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Daclizumab (Zinbryta▼) 150 mg solution for injection is authorised for adults with relapsing forms of multiple sclerosis. Initiate daclizumab in restricted groups of patients who have highly active relapsing multiple sclerosis that has failed to respond to at least one disease-modifying therapy or severe relapsing multiple sclerosis unsuitable for treatment with other disease-modifying therapies.
Treatment with daclizumab is contraindicated in patients with pre-existing hepatic disease or hepatic impairment. Treatment initiation is not recommended in patients with alanine transaminase or aspartate aminotransferase 2 or more times the upper limit of normal.Treatment initiation is not recommended in patients with a history of concurrent autoimmune conditions (except for multiple sclerosis). Caution should be used when concomitantly administering medicinal products of known hepatotoxic potential, including non-prescription products and herbal supplements.
Wide review of daclizumab started after the death from liver injury (fulminant liver failure) of a patient involved in an ongoing observational study, as well as 4 cases of serious liver injury. The risk of liver damage with daclizumab was already known at time of its approval in the EU. Several measures are already in place to manage this risk, including the requirement to monitor liver function regular...