Tenapanor and Breastfeeding

Summary of use during lactation

Tenapanor is virtually not absorbed systemically, with undetectable plasma concentrations following oral administration. Tenapanor and its major metabolite were not detected in the breastmilk of lactating women. No special precautions are necessary.

Drug levels in milk and infant serum

Maternal Levels. A clinical lactation study was conducted in seven healthy women. Following oral administration of tenapanor 50 mg twice daily for 3 days, milk samples were collected before a dose then at 1, 2, 4, 6, 8, and 24 hours after the dose. The concentrations of tenapanor and its major metabolite were undetectable (<1 mcg/L) in all milk samples collected over 24 hours after a dose.[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.

References

1. Brenner DM, Raju K, Kozuka K, et al. Neither tenapanor nor its major metabolite were detected in the breast milk of healthy lactating females after 4 days of dosing: A phase 1, open-label, pharmacokinetic study. Gastroenterology 2025;169:S–499. doi:10.1016/S0016-5085(25)02085-2