Fexinidazole use while Breastfeeding

Summary of Use during Lactation

No adverse effects to breastfed infants have been associated with fexinidazole exposure through breastmilk based on a limited number of reported cases. If a mother requires fexinidazole, it is not a reason to discontinue breastfeeding. Until more data are available, fexinidazole should only be used during breastfeeding with careful infant monitoring for vomiting, insomnia, nausea, tremor, and decreased appetite.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

According to the manufacturer, no adverse effects to the breastfed child have been associated with fexinidazole exposure through breastmilk based on a limited number of reported cases.

In a phase 3b, prospective, open-label, non-randomized, cohort study of fexinidazole for treating gambiense African trypanosomiasis in the Democratic Republic of the Congo, 17 infants were breastfed (extent not stated, but probably exclusively). The babies developed normally, except one who died from a neonatal infection and two who died because of anemia in the context of severe or complicated malaria. None of these fatalities were considered related to fexinidazole.[1]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

References

1.

Kumeso VKB, Perdrieu C, Menétrey C, et al. Effectiveness and safety of fexinidazole for gambiense human African trypanosomiasis and exploration of adherence in outpatients: A phase 3b, prospective, open-label, non-randomised, cohort study. Lancet Glob Health 2025;13:e900–e09. [PMC free article: PMC12041186] [PubMed: 40288399]

Substance Name

Fexinidazole

CAS Registry Number

59729-37-2

Drug Class

Breast Feeding

Lactation

Milk, Human

Anti-Infective Agents

Antiprotozoal Agents

Nitroimidazoles