Dimethyl Fumarate Levels and Effects while Breastfeeding
Summary of Use during Lactation
No information is available on the clinical use of dimethyl fumarate during breastfeeding. However, amounts of the active metabolite of dimethyl fumarate, monomethyl fumarate, in breastmilk appear to be low and would not be expected to cause any adverse effects in breastfed infants. Before any data were available, some authors recommend avoiding breastfeeding during dimethyl fumarate therapy,[1,2] others and the US manufacturer did not.[3] Breastfed infants should be monitored for adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants. Some authors also recommend monitoring breastfed infants for flushing, vomiting and diarrhea.[3,4]
Drug Levels
Dimethyl 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 oral dimethyl fumarate 240 mg 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.[4]
Infant Levels. Relevant published information was not found as of the revision date.
Effects in Breastfed Infants
Relevant published information was not found as of the revision date.
Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date.
Bove R, Alwan S, Friedman JM, et al. Management of multiple sclerosis during pregnancy and the reproductive years: A systematic review. Obstet Gynecol. 2014;124:1157–68. [PubMed: 25415167]
2.
Thöne J, Thiel S, Gold R, et al. Treatment of multiple sclerosis during pregnancy - safety considerations. Expert Opin Drug Saf. 2017;16:523–34. [PubMed: 28333552]
3.
Almas S, Vance J, Baker T, et al. Management of multiple sclerosis in the breastfeeding mother. Mult Scler Int. 2016;2016:6527458. [PMC free article: PMC4757692] [PubMed: 26966579]
4.
Ciplea AI, Datta P, Rewers-Felkins K, et al. Dimethyl fumarate transfer into human milk. Ther Adv Neurol Disord. 2020;13 [PMC free article: PMC7607748] [PubMed: 33193814] [CrossRef]
Substance Identification
Substance Name
Dimethyl Fumarate
CAS Registry Number
624-49-7
Drug Class
Breast Feeding
Lactation
Milk, Human
Dermatologic Agents
Immunosuppressive Agents
Radiation-Sensitizing Agents
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