Summary of Use during Lactation

Linaclotide is minimally absorbed from the gastrointestinal tract and the drug and its active metabolite is not measurable in plasma following administration of recommended doses. Linaclotide would not be expected to enter the breastmilk or cause any adverse effects in breastfed infants. Linaclotide appears to be acceptable in nursing mothers and no special precautions are required.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date. However, the manufacturer reports that following oral administration of 72 mcg, 145 mcg, or 290 mcg of linaclotide once daily for 3 days to breastfeeding mothers taking linaclotide therapeutically, the concentrations of linaclotide and its metabolite were below the limits of quantitation (<0.25 mcg/L and <1 mcg/L, respectively) in all breast milk samples collected over 24 hours. No further details were provided.

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

Substance Name

Linaclotide

CAS Registry Number

851199-59-2

Drug Class

Breast Feeding

Lactation

Gastrointestinal Agents

Peptides

Guanylate Cyclase C Agonists

Laxatives