Linaclotide

The Basics

What is Linaclotide?

Used to treat irritable bowel syndrome with constipation and chronic constipation with no known cause.

Brand names for Linaclotide

Linzess

How Linaclotide is classified

Gastrointestinal Agents, Peptides, Guanylate Cyclase C Agonists, Laxatives

Linaclotide During Pregnancy

Linaclotide pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Linaclotide while pregnant

Linaclotide and its active metabolite are negligibly absorbed systemically following oral administration [see CLINICAL PHARMACOLOGY], and maternal use is not expected to result in fetal exposure to the drug.The available data on LINZESS use in pregnant women are not sufficient to inform any drug-associated risk for major birth defects and miscarriage. In animal developmental studies, no effects on embryo-fetal development were observed with oral administration of linaclotide in rats and rabbits during organogenesis at doses much higher than the maximum recommended human dosage. Severe maternal toxicity associated with effects on fetal morphology were observed in mice . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Taking Linaclotide While Breastfeeding

What are recommendations for lactation if you're taking Linaclotide?

No information is available on the use of linaclotide during breastfeeding. 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 and cause any adverse effects in breastfed infants

Maternal / infant drug levels

No information is available on the use of linaclotide during breastfeeding. 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 and cause any adverse effects in breastfed infants

Possible effects of Linaclotide on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Linaclotide

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