Products
Daclizumab was approved in the United States and EU in 2016 and in many countries in 2017 as a solution for injection for MS treatment (Zinbryta). In 2018, the drug was withdrawn from the market due to serious adverse effects. These adverse effects included liver damage and reports of encephalopathies (encephalitis, meningoencephalitis). Daclizumab had been approved in many countries since 1998 as an infusion concentrate to prevent rejection after kidney transplantation (Zenapax). Zenapax is now no longer available.
Structure and properties
Daclizumab is a humanized IgG1 monoclonal antibody with a molecular weight of 144 kDa. It is produced by biotechnological methods.
Effects
Daclizumab (ATC L04AC01) has immunosuppressive properties. The antibody binds to CD25, the alpha subunit of the interleukin-2 receptor (IL-2R) on T lymphocytes, and interacts with interleukin-2 (IL-2) to inhibit it. This reduces the number of activated T cells. Daclizumab has a long half-life of 21 days.
Indications
For the treatment of adult patients with relapsing-remitting multiple sclerosis (Zinbryta). Formerly: prophylaxis of acute rejection after allogeneic renal transplantation (Zenapax).
Dosage
According to the SmPC. The solution for injection is injected subcutaneously once a month.
Contraindications
- Hypersensitivity
- Severe active infections as well as patients at increased risk
- Active chronic infections
For complete precautions, see the drug label.
Interactions
Daclizumab should not be combined with drugs that are toxic to the liver.
Adverse effects
The most common possible adverse effects include a rash, an increase in alanine aminotransaminases (ALT), and depression. Rarely, severe liver injury may occur.