Summary of Use during Lactation

Linaclotide is minimally absorbed from the gastrointestinal tract and the drug and its active metabolite are not measurable in milk following administration of doses up to 290 mcg daily. Linaclotide appears to be acceptable in nursing mothers and no special precautions are required.

Drug Levels

Linaclotide is metabolized in the gastrointestinal tract to its active metabolite, MM-419447.

Maternal Levels. In a multicenter study, 7 lactating women were taking linaclotide in doses of 72 mcg (n = 5), 145 mcg (n = 1) or 290 mcg (n = 1) once daily. Milk was pumped on day 1 and day 3 of the study. Over 24-hours of milk collection on day 3, concentrations of linaclotide and MM-419447 in milk samples were below the quantitation limits (<0.25 mcg/L and <1 mcg/L, respectively) at all time points in all participants.[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.

Alternate Drugs to Consider

(Irritable Bowel Syndrome) Lubiprostone, Plecanatide, Polyethylene Glycol, Psyllium, Tenapanor

References

1.

Crittenden N, McGeeney D, Assouline-Dayan Y, et al. Linaclotide is not detectable in breast milk of lactating women: An open-label, phase 1 study. J Can Assoc Gastroenterol 2021;4 (Suppl 1):Abstract A236.

Substance Name

Linaclotide

CAS Registry Number

851199-59-2

Drug Class

Breast Feeding

Lactation

Milk, Human

Gastrointestinal Agents

Peptides

Guanylate Cyclase C Agonists

Laxatives