Linaclotide Brand Name– Linzess
What is Linaclotide
Linaclotide is a selective guanylate cyclase C agonist indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in adults.
Safety and effectiveness for the management of IBS-C were established in 2, double-blind clinical trials.
In clinical studies, linaclotide (290 mcg) was associated with a reduction in the amount of abdominal pain as well as an increase in the number of complete spontaneous bowel movements compared to placebo.
Safety and effectiveness were established for the management of CIC in 2 additional double-blind clinical studies. In these studies, patients randomized to receive linaclotide (145 mcg or 290 mcg) experienced more complete spontaneous bowel movements as compared to placebo.
Other drug-associated benefits observed during each clinical study included improvements in the frequency and consistency of spontaneous bowel movements, as well as improvements in the amount of straining with each bowel movement.
A 72 mcg dose is also available for patients with CIC. Of note, the 290 mcg dose is not approved for CIC due to a lack of greater efficacy compared to the 145 mcg dose.
Linaclotide approval was subject to a boxed warning alerting against its use in pediatric patients 17 years of age and younger. Diarrhea was the most common side effect reported during clinical evaluation.
Linaclotide (Linzess) was approved August 2012
- irritable bowel syndrome
For the treatment of chronic idiopathic constipation (CIC)
- abdominal pain
- fecal incontinence
- gastroesophageal reflux
- GI bleeding
- laboratory monitoring not necessary
- abdominal pain
- Crohn’s disease
- fecal impaction
- gastric cancer
- GI disease
- GI obstruction
- inflammatory bowel disease
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