Tecfidera (dimethyl fumarate) was detected in the breast milk of two women using the oral therapy to treat their multiple sclerosis, but at concentrations well below the “theoretical threshold of concern” for an infant, a case study reported.
According to its investigators, this is the first evidence of Tecfidera’s transfer to the breast milk of relapsing-remitting multiple sclerosis (RRMS) patients, and levels found there — even at peak concentration — were acceptably low and not accumulating, suggesting Tecfidera might be compatible with breastfeeding.
Larger and more extensive studies are needed for confirmation, they added.
Tecfidera, marketed by Biogen, is an oral medication that reduces MS exacerbations and flares by modulating the immune response. It is widely approved as a first-line treatment of RRMS, including across Europe, and for all relapsing forms of MS in the U.S.
Following intake, Tecfidera is metabolized into the active metabolite monomethyl fumarate (MMF). Its safety while breastfeeding and the risk of MMF transfer to the infant through breast milk are unknown, and patients taking Tecfidera are advised either to assess risks and benefits or to discontinue the therapy.
Researchers in Germany sought to determine if MMF is excreted into breast milk at a concentration harmful to the nursing infant.
Two RRMS patients, both breastfeeding mothers with the German MS and pregnancy registry, took part in their study. The women stopped breastfeeding when their disease required them to resume Tecfidera at a standard twice-daily oral dose of 240 mg.
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