Summary of Use during Lactation

Maternal intravenous eflornithine 400 mg/kg daily for 7 days did not cause any adverse serious effects in breastfed infants. After topical application, eflornithine is poorly absorbed so it is not likely to reach the bloodstream of the infant or cause any adverse effects in breastfed infants.

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

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, including amoxicillin, ciprofloxacin, metronidazole, trimethoprim-sulfamethoxazole, aspirin, and diclofenac (1 patient each); hydrocortisone, promethazine and quinine (2 patients each); levamisole (6 patients); sulfadoxine-pyrimethamine (8 patients); dipyrone (13 patients); acetaminophen (16 patients); and mebendazole (17 patients). No serious adverse events were reported in any of the breastfed infants.[1-3]

Effects on Lactation and Breastmilk

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

References

1.

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. [PMC free article: PMC3510081] [PubMed: 23209861]

2.

Kuemmerle A, Schmid C, Kande V, et al. Prescription of concomitant medications in patients treated with nifurtimox eflornithine combination therapy (NECT) for T.b. gambiense second stage sleeping sickness in the Democratic Republic of the Congo. PLoS Negl Trop Dis. 2020;14:e0008028. [PMC free article: PMC7004379] [PubMed: 31986140]

3.

Kuemmerle A, Schmid C, Bernhard S, et al. Effectiveness of nifurtimox eflornithine combination therapy (NECT) in T. b. gambiense second stage sleeping sickness patients in the Democratic Republic of Congo: Report from a field study. PLoS Negl Trop Dis. 2021;15:e0009903. [PMC free article: PMC8601604] [PubMed: 34748572]

Substance Name

Eflornithine

CAS Registry Number

70052-12-9

Drug Class

Breast Feeding

Lactation

Antiparasitic Agents

Antiprotozoal Agents

Enzyme Inhibitors

Trypanocidal Agents