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. 2020 Oct 31:13:1756286420968414.
doi: 10.1177/1756286420968414. eCollection 2020.

Dimethyl fumarate transfer into human milk

Andrea I Ciplea  1 , Palika Datta  2 , Kathleen Rewers-Felkins  2 , Teresa Baker  3 , Ralf Gold  1 , Thomas W Hale  2 , Kerstin Hellwig  4
Affiliations

Dimethyl fumarate transfer into human milk

Andrea I Ciplea et al. Ther Adv Neurol Disord. .

Abstract

Dimethyl fumarate (DMF) is approved for the treatment of relapsing-remitting multiple sclerosis. It is unknown whether DMF or its primary metabolite monomethyl fumarate (MMF) are excreted into human milk. We present two cases of lactating patients who donated milk samples to study the transfer of MMF into human milk following a week of 2 × 240 mg daily oral dose. Samples were analyzed using liquid chromatography mass spectrometry. The calculated relative infant dose was 0.019% and 0.007%. This is the first study to demonstrate that MMF is transferred into human milk, with only limited exposure to an infant.

Keywords: Multiple sclerosis; dimethyl fumarate; human milk; lactation; tecfidera.

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Conflict of interest statement

Conflict of interest statement: Andrea I. Ciplea has received speaker honoraria from Bayer Healthcare and travel grants from Sanofi Genzyme, Teva and Novartis. Palika Datta declares that there is no conflict of interest. Kathleen Rewers-Felkins declares that there is no conflict of interest. Teresa Baker is a consultant for Biohaven Pharmaceuticals. Ralf Gold has received payments for consultancy from Biogen and Teva; speaker honoraria and research grants from Biogen Idec Germany, Teva, Sanofi Aventis, Novartis, Bayer Healthcare and Merck Serono. Thomas W. Hale is a consultant for Biohaven Pharmaceuticals. Kerstin Hellwig has received travel grants from Biogen, Novartis and Merck; received speaker and research honoraria from Biogen Idec Germany, Teva, Sanofi Genzyme, Novartis, Bayer Healthcare, Merck Serono and Roche. Ralf Gold is the Editor-in-Chief of Therapeutic Advances in Neurological Disorders. Therefore, the peer review and editorial decision-making process was managed by alternative members of the Board and the submitting Editor was not involved in the decision-making process.

Figures

Figure 1.
Figure 1.
Concentration–time profile of MMF in human milk (n = 2). MMF concentrations (in ng/ml; bars indicate SEM in milk of patient 1 (@) and patient 2 [X] over a time course of 12 h after intake of 240 mg DMF. DMF, dimethyl fumarate; MMF, monomethyl fumarate; SEM, standard error of mean.
See this image and copyright information in PMC

References

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