Nifurtimox use while Breastfeeding
Nifurtimox Levels and Effects while Breastfeeding
Summary of Use during Lactation
Limited information indicates that maternal doses of nifurtimox up to 15 mg/kg daily produce do not cause any adverse serious effects in breastfed infants. Breastmilk levels and a computer simulation found that the dose that an exclusively breastfed infant would receive through breastmilk would be much less than the dose given to treat Chagas disease in newborn infants. Other authors consider that breastfeeding is not contraindicated during the use of nifurtimox.
Maternal Levels. A computer simulation using pharmacokinetic data from adults and assuming milk-plasma ratios of 1 resulted in an estimated median infant dose of 0.19% of the maternal weight-adjusted dosage. Assuming milk-plasma ratios of 6 resulted in an estimated maximum infant dose of 3.1% of the maternal weight-adjusted dosage.
Four women with Chagas disease were treated with nifurtimox 10 to 15 mg/kg daily in 3 divided doses provided breastmilk samples for analysis after 4 to 10 days of therapy. The timing of the sample with respect to doses was not reported. Breastmilk concentrations of nifurtimox ranged from nonquantifiable (<0.55 mg/L) to 8.2 mg/L.
Infant Levels. Relevant published information was not found as of the revision date.
Effects in Breastfed Infants
A cohort of 33 infants who were breastfed (extent not stated) by hospitalized mothers taking nifurtimox was followed in the Democratic Republic of the Congo. Thirty mothers took a full course of 30 doses of oral nifurtimox 15 mg/kg daily and all received 14 doses of intravenous eflornithine 400 mg/kg daily for 7 days for human African trypanosomiasis. (sleeping sickness). Nursing mothers also took a median of 4 other concomitant medications. No serious adverse events were reported in any of the breastfed infants.
Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date.
1. Sankale M, Brun A. Les medicaments des parasitoses tropicales au cours de la grossesse et de l'allaitement. (2 parts). Concours Medl. 1991;14:2335-9; 2248-51.
2. Barennes H, Choonara I. Breast feeding and drug therapy in neglected diseases. Arch Dis Child. 2010;95:222-3. PMID: 20308339
3. Garcia-Bournissen F, Altcheh J, Panchaud A, Ito S. Is use of nifurtimox for the treatment of Chagas disease compatible with breastfeeding? A population pharmacokinetics analysis. Arch Dis Child. 2010;95:224-8. PMID: 19948512
4. Padro JM, Vidal RB, Echevarria RN et al. Development of an ionic-liquid-based dispersive liquid-liquid microextraction method for the determination of antichagasic drugs in human breast milk. Optimization by central composite design. J Sep Sci. 2015;38:1591-600. PMID: 25711461
5. Schmid C, Kuemmerle A, Blum J et al. In-hospital safety in field conditions of nifurtimox eflornithine combination therapy (NECT) for T. b. gambiense sleeping sickness. PLoS Negl Trop Dis. 2012;6:e1920. PMID: 23209861
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