Natalizumab - MS Research Australia

Natalizumab

Natalizumab

Administration Route: Infusion
Injection site:
Frequency: monthly
TGA approval date: Nov 2006
PBS listed: Yes
Mechanism of action Binds to the α4-subunit of α4b 1 and α4b 7 integrins expressed on the surface of all leukocytes except neutrophils, and inhibits the α4-mediated adhesion of leukocytes to their counter-receptor(s).
%reduction in relapse rate, impact of progression 68% RRR in annual relapes rate,92% RRR for new Gad Lesions, 83% RRR new T2 lesions, 54% 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.
Breastfeeding (information predominatly from  LACTMED database) One case indicates that natalizumab is excreted into breastmilk in increasing amounts over several weeks after initiation of therapy. The actual time of the peak level is unknown, but might be as long as 6 months. Because natalizumab is a large protein molecule with a molecular weight of about 149,000, absorption is unlikely because it is probably destroyed in the infant’s gastrointestinal tract. Some, but not all, experts recommend avoiding breastfeeding with natalizumab. Until more data become available, natalizumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.
Monitoring requirements Liver function test, 3-12 monthly. JCV antibody 6 monthly
Potential side effects (not a comprehensive list) PML, pain or stinging when passing urine, sore throat, runny or blocked up nose, shivering, itchy rash (hives), headache, dizziness, nausea, vomiting, joint pain, fever, tiredness.
Manufacturer Biogen
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