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Published on: April 13, 2019
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Dimethyl fumarate transfer into human milk.
Andrea I Ciplea1, Palika Datta2, Kathleen Rewers-Felkins2
1Department of Neurology, St. Josef Hospital, Ruhr University Bochum, Germany.
Therapeutic Advances in Neurological Disorders
|November 16, 2020
Summary
Dimethyl fumarate (DMF) treatment for multiple sclerosis may transfer its metabolite, monomethyl fumarate (MMF), into breast milk. This study found limited MMF exposure in infants via human milk.
Area of Science:
- Pharmacology
- Toxicology
- Human Lactation
Background:
- Dimethyl fumarate (DMF) is a key therapy for relapsing-remitting multiple sclerosis (MS).
- The excretion of DMF or its metabolite, monomethyl fumarate (MMF), into human breast milk is not well understood.
- Assessing infant exposure is crucial for breastfeeding mothers with MS.
Purpose of the Study:
- To investigate the transfer of monomethyl fumarate (MMF) into human milk.
- To quantify infant exposure to MMF through breastfeeding.
Main Methods:
- Two lactating patients undergoing oral DMF treatment donated milk samples.
- Samples were analyzed using liquid chromatography-mass spectrometry (LC-MS).
- Relative infant doses (RID) were calculated based on MMF concentrations.
Main Results:
- Monomethyl fumarate (MMF) was detected in human milk samples from mothers taking dimethyl fumarate (DMF).
- The calculated relative infant doses were low, at 0.019% and 0.007%.
- This represents the first study to quantify MMF transfer into human milk.
Conclusions:
- Monomethyl fumarate (MMF) is transferred into human milk following maternal dimethyl fumarate (DMF) therapy.
- Infant exposure to MMF via breastfeeding appears to be limited.
- These findings provide initial data for counseling breastfeeding mothers with MS on DMF use.

