Multiple Sclerosis Centers of Excellence
Daclizumab (Zinbryta®) is a medication administered by monthly SC injection for the treatment of relapsing forms of MS. Daclizumab is an interleukin-2 receptor (IL-2R) blocking monoclonal antibody. It is theorized to bind to the alpha subunit (DC25) of the IL-2R expressed on activated T lymphocytes, thereby preventing interaction of IL-2 with its high-affinity receptor. This inhibits activation of CNS antigen-experienced proinflammatory activated T lymphocytes involved in the demyelinating process. Daclizumab has a black box warning for risk of severe liver injury, including liver failure and autoimmune hepatitis, and immune-mediated disorders, including skin reactions and lymphadenopathy. Because of its safety profile, daclizumab should generally be reserved for people who have had an inadequate response to two or more DMTs. Daclizumab is available only through a restricted distribution program called the ZINBRYTA REMS Program.
March 2, 2018 Alert
Biogen and AbbVie have announced the voluntary worldwide withdrawal of daclizumab (Zinbryta®) following an urgent review of eight cases of inflammatory encephalitis and meningoencephalitis under urgent review by the European Medicines Agency (EMA). The companies and the regulatory authorities have said that patients currently on the drug should consult with their doctors as soon as possible, but to not stop taking the drug before discussing it with their physicians. Biogen and Abbvie have stated that given the nature and complexity of adverse events being reported, characterizing the evolving benefit/risk profile of daclizumab will not be possible going forward given the limited number of patients being treated. Therefore, Biogen and AbbVie believe it is in the best interest of patients to voluntarily withdraw worldwide marketing authorizations for daclizumab.
The VA has very few Veterans on daclizumab. The details of the Class 1 recall in VA can be found here: http://vaww.recalls.ncps.med.va.gov/WebRecalls/Recalls.html. VA Pharmacy Benefits Management has notified the pharmacies and will be working with pharmacists and the providers on an appropriate transition.
For Additional Information
- VA Daclizumab (Zinbryta®) Criteria for Use
- VA Daclizumab (Zinbryta®) Drug Monograph
- VA Adverse Drug Events Reporting System
- Daclizumab (Zinbryta®) Prescribing Information for Healthcare Professionals
- Daclizumab (Zinbryta®) Medication Guide for Patients
- Zinbryta® (website for patients and healthcare professionals)