Daclizumab - MS Research Australia

Daclizumab

Daclizumab – [withdrawn]

Administration Route: Injection
Injection site:
Frequency: Monthly
TGA approval date: Sep 2016
PBS listed: Yes
Mechanism of action Daclizumab is a humanized monoclonal antibody that binds to CD25 (IL-2Rα), and prevents IL-2 binding to CD25. The immunomodulatory effects of daclizumab are believed to reduce CNS pathology in MS and thereby reduce the occurrence of relapses and disability progression
%reduction in relapse rate, impact of progression 56% RRR in annual relapes rate,31% RRR for new Gad Lesions, 30% RRR new T2 lesions, 24% RRR disability
Pregnancy Category C
Safe in Pregnancy Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
Breastfeeding (information predominatly from  LACTMED database) No information is available on the clinical use of daclizumab during breastfeeding. Because daclizumab is a large protein molecule with a molecular weight of about 144,000, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant’s gastrointestinal tract. Until more data become available, daclizumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.
Monitoring requirements Liver function, monthly
Potential side effects (not a comprehensive list) Infections, anemia, depression, rash, fever, elevation of alanine aminotransferase levels.
Manufacturer Biogen
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