Plecanatide and Breastfeeding

Summary of use during lactation

Plecanatide is not absorbed from the gastrointestinal tract and the drug and its active metabolite are not measurable in milk following administration of recommended doses to nursing mothers. Plecanatide is not expected to cause any adverse effects in breastfed infants. No special precautions are required.

Drug levels in milk and infant serum

Maternal Levels. Plecanatide 3 mg was administered orally once daily for 2 weeks to 7 mothers who had been nursing for at least 4 weeks. Plecanatide and its active metabolite were not measurable (detection limit not specified) in breastmilk samples collected before a dose or at 2, 6, or 12 hours after a dose.[1,2] 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

(Irritable Bowel Syndrome) Linaclotide, Lubiprostone, Prucalopride, Psyllium, Tenapanor

References

1. Bausch Health Americas Inc. A postmarketing study of plecanatide in breast milk of lactating women treated with Trulance. Clinical Trials.gov 2018:NCT03551873. https://clinicaltrials.gov/ct2/show/NCT03551873?term=NCT03551873&draw=2&rank=1
2. Salix Pharmaceuticals Inc. Trulance Package Insert. 2020