linaclotide (Linzess)

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.

What brand names are available for linaclotide (Linzess)?

Linzess

Is linaclotide (Linzess) available as a generic drug?

No

Do I need a prescription for linaclotide (Linzess)?

Yes

The most common side effects of linaclotide are:

• diarrhea,
• stomach pain,
• gas, and
• stomach distention.

Linaclotide should be stopped if patients develop severe diarrhea. Other important side effects include:

• headache,
• fatigue,
• respiratory infections,
• sinusitis, and
• stomach or intestinal viral infections.

Rarely, patients may experience passage of blood from the rectum.

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 interaction studies have not been conducted.

Linaclotide has not been adequately evaluated in pregnant women.

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.

What preparations of linaclotide (Linzess) are available?

Capsules: 145 and 290 mcg

How should I keep linaclotide (Linzess) stored?

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.