Dimethyl fumarate - MS Research Australia

Dimethyl fumarate

Dimethyl fumarate

Administration Route: Oral
Injection site:
Frequency: Two times daily
TGA approval date: Jul 2013
PBS listed: Yes
Mechanism of action Tecfidera (dimethyl fumarate) is an oral, small molecule immune modulator. The mechanism by which dimethyl fumarate exerts its therapeutic effect in multiple sclerosis is unknown. However, it has been postulated that dimethyl fumarate has the potential to reduce the activity and impact of inflammatory cells on the central nervous system (CNS) and induce direct cytoprotective responses in CNS cells.
%reduction in relapse rate, impact of progression 53% RRR in annual relapes rate,90% RRR for new Gad Lesions, 85% RRR new T2 lesions, 38% RRR disability
Pregnancy Category B1
Safe in Pregnancy Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Breastfeeding (information predominatly from  LACTMED database) There is no published experience with dimethyl fumarate during breastfeeding. Although the drug is not contraindicated during breastfeeding, some authors recommend its avoidance. An alternate drug may be preferred, especially while nursing a newborn or preterm infant.
Monitoring requirements Complete blood count every 3 mths
Potential side effects (not a comprehensive list) Flushing, abdominal pain, diarrhea, nausea, Lymphopenia, risk of PML
Manufacturer Biogen
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