Is Diroximel Fumarate safe while breastfeeding?
Here is what NIH LactMed, the U.S. National Library of Medicine's authority on medicines and breastfeeding, reports about Diroximel Fumarate. This is a summary of that source — not our own verdict.
Effects on the breastfed infant
Twenty-six women taking dimethyl fumarate for relapsing-remitting multiple sclerosis were followed during 29 pregnancies from 2015 to 2020. Dimethyl fumarate was administered through week 24 of pregnancy and resumed 1 month after delivery. Twenty-two of 26 mothers breastfed (extent not stated) for 4 to 7 months. Infants were monitored up to the third year of life for infections and developmental disorders. All children were the 70th and 95th percentile for height and weight. The authors concluded that continuing dimethyl fumarate while breastfeeding is safe,[ 1 ] although infants were not exposed during the first month of life.
Effects on milk supply
Relevant published information was not found as of the revision date.
Levels in milk
Diroximel fumarate is not found in the plasma because it is rapidly converted to the active drug, monomethyl fumarate, which has a half-life of about 1 hour. Maternal Levels. Two nursing mothers with relapsing-remitting multiple sclerosis began the closely related drug dimethyl fumarate 240 mg orally twice daily after discontinuing breastfeeding. They continued pumping milk and on day 8 of therapy, they each provided milk samples at 1, 2, 4, 8 and 12 hours after a dose. Peak monomethyl fumarate milk levels were 3.7 mcg/L in one mother and 11.2 mcg/L in the other and occurred at about 2 hours after the dose. Average milk levels were 2.7 mcg/L and 7.5 mcg/L, respectively. These values indicate that the infants would receive daily dosages of about 0.8 mcg/kg and 1.13 mcg/kg, respectively, or weight-adjusted relative infant dosages of 0.007% and 0.019% of the maternal dosage.[ 3 ] Infant Levels. Relevant published information was not found as of the revision date.
Alternatives LactMed lists
Source: NIH LactMed (National Library of Medicine).
Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.