Ibrexafungerp and Breastfeeding

Summary of use during lactation

No information is available on the clinical use of ibrexafungerp during breastfeeding. However, the amounts in milk are low and unlikely to affect the breastfed infant. If ibrexafungerp is required by the mother of an older infant, it is not a reason to discontinue breastfeeding, but until more data become available, use caution especially while nursing a newborn or preterm infant.

Drug levels in milk and infant serum

Maternal Levels. The manufacturer repots a milk-only pharmacokinetic lactation study that evaluated concentrations of ibrexafungerp in the plasma and breast milk of 5 healthy lactating women, who were between 33 and 346 days postpartum. Two oral doses of 300 mg of ibrexafungerp were administered 12 hours apart for one day. Ibrexafungerp was detected in breastmilk with a median peak concentration of 72.22 mcg/L (range 32.1 to 94.1 mcg/L) in the 2- to 4- hour milk collection and an average concentration of 45.39 mcg/L. The mean calculated daily infant dosage was 0.05 mg which is <1% of the maternal weight-adjusted dose or RID.[1] 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.

Alternative drugs to consider

Clotrimazole, Fluconazole, Miconazole, Nystatin

References

1. Scynexis Inc. Pharmacokinetic study in healthy lactating women exposed to ibrexafungerp. 2025. https://clinicaltrials.gov/study/NCT06954493?intr=NCT06954493&rank=1&tab=results#results-overview