Natalizumab

Natalizumab

Administration Route: Infusion
Injection site:
Frequency: Every four weeks
TGA approval date: Nov 2006
PBS listed: Yes
Mechanism of action Binds to the surface of white blood cells (except neutrophils) and stops them moving across the blood brain barrier to the brain and spinal cord where the site of inflammation is.
%reduction in relapse rate, impact of progression 68% reduction in annualised relapse rate

92% RRR for new Gad Lesions

83% RRR new T2 lesions

42% reduction in disability risk

Pregnancy Category C
Safe in Pregnancy Studies in laboratory models have shown reproductive toxicity.

There are no adequate and well-controlled studies of natalizumab therapy in pregnant women. This drug should be used during pregnancy only if clearly needed. If a woman becomes pregnant while taking natalizumab, discontinuation of therapy should be considered.

Breastfeeding (information predominatly from  LACTMED database) Natalizumab is excreted into breastmilk in some, but not all, women. The time of the peak level in breastmilk is variable, but might be as long as 6 months. Because natalizumab is a large protein molecule, absorption is unlikely because it is probably destroyed in the infant’s gastrointestinal tract. Some experts recommend avoiding breastfeeding with natalizumab, while others do not. 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 if there’s a history of liver disease

JCV antibody testing every 6 months

Annual MRIs to check for progressive multifocal leukoencephalopathy (PML). This is a severe viral infection of the brain.

Potential side effects (not a comprehensive list) PML, urinary tract infection, sore throat, runny or blocked up nose, shivering, rash, headache, depression, diziness, nausea, fever, hypertension, tiredness.
Manufacturer Biogen
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