linaclotide (Linzess)

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Pharmacy Author:

Omudhome Ogbru, PharmD

Omudhome Ogbru, PharmD

Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in 1995. He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in 1996. He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from 1996-99.

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Medical and Pharmacy Editor:

Jay W. Marks, MD

Jay W. Marks, MD

Jay W. Marks, MD, is a board-certified internist and gastroenterologist. He graduated from Yale University School of Medicine and trained in internal medicine and gastroenterology at UCLA/Cedars-Sinai Medical Center in Los Angeles.

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GENERIC NAME: linaclotide

BRAND NAME: Linzess

DRUG CLASS AND MECHANISM: Linaclotide is an oral medication for the treatment of constipation. It is the first in a new class of drugs called guanylate cyclase-C agonists. It is used for relieving symptoms of irritable bowel syndrome (IBS) with constipation and for treating chronic constipation of unknown cause (idiopathic constipation). Linaclotide works locally in the intestine (it is not absorbed into the body) to increase bowel movements and reduce pain. Linaclotide's effects are due to an increase in the production of a chemical called cyclic guanosine monophosphate which increases fluid secretion into the intestine and reduces the sensitivity of pain-sensing nerves. The FDA approved linaclotide in August 2012.

PRESCRIPTION: Yes

GENERIC AVAILABLE: No

PREPARATIONS: Capsules: 145 and 290 mcg

STORAGE: Linaclotide should be stored at room temperature, 15 C to 30 C (59 F to 86 F). It should be kept in the original container and protected from moisture. The dessicant (drying agent) should not be removed from the container.

PRESCRIBED FOR: Linaclotide is used for treatment of adults with IBS and constipation and for treating chronic constipation of unknown cause. It should not be used in children 17 years old or younger.

DOSING: The dose for treating IBS with constipation is 290 mcg once daily, and the dose for treating chronic idiopathic constipation is 145 mcg once daily. Linaclotide should be taken on an empty stomach at least 30 minutes before the first meal of the day.

DRUG INTERACTIONS: Drug interaction studies have not been conducted.

PREGNANCY: Linaclotide has not been adequately evaluated in pregnant women.

NURSING MOTHERS: It is not known whether linaclotide is excreted in human milk. It is unlikely that linaclotide is excreted in breast milk because it is poorly absorbed and therefore undetectable in blood at recommended doses.

SIDE EFFECTS: The most common side effects are diarrhea, stomach pain, gas, and stomach distention. Linaclotide should be stopped if patients develop severe diarrhea. Headache, fatigue, respiratory infections, sinusitis, and stomach or intestinal viral infections also may occur. Rarely, patients may experience passage of blood from the rectum.

Reference: FDA Prescribing Information

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