LINACLOTIDE CAP,ORAL

Clinical Criteria Summary

Mechanical gastrointestinal obstruction, known or suspected
Age less than 18 years
Presence of severe or frequent diarrhea
Chronic idiopathic constipation (CIC) excludes drug-induced chronic constipation and chronic constipation due to neurogenic and non-neurogenic disorders

Men or women 18 years or older with a documented diagnosis of chronic idiopathic constipation (CIC)
Intolerance or inadequate response to a 1-month trial of at least one bulk forming laxative (e.g., psyllium, oxidized cellulose, calcium polycarbophil) with fluids unless there is a contraindication or risk factor(s) for serious adverse event(s)
Intolerance or inadequate response to a 1-month trial of either PEG-3350 powder for oral solution (17 g twice daily) or other osmotic laxative, unless there is a contraindication or risk factor(s) for serious adverse event(s)
Intolerance or inadequate response to a 1-month trial of lubiprostone (24 mcg twice daily) unless there is a contraindication or risk factor(s) for serious adverse event(s)

GI consultation (including e-consult) is highly recommended prior to using linaclotide for CIC
Examples of osmotic laxatives include lactulose, sorbitol, magnesium citrate, magnesium hydroxide, and glycerin rectal suppositories
During the 1-month trial, escalation/titration of therapy up to bowel-prep doses of PEG-3350 may be considered case by case to achieve the desired response

Mechanical gastrointestinal obstruction, known or suspected
Age less than 18 years
Presence of severe or frequent diarrhea
IBS excludes drug-induced chronic constipation and chronic constipation due to neurogenic and non-neurogenic disorders

Men or women 18 years or older with irritable bowel syndrome with constipation (IBS-C)
Intolerance or inadequate response to a 1-month trial of either PEG-3350 powder for oral solution or other osmotic laxative, unless there is a contraindication or risk factor(s) for serious adverse event(s)
GI consultation (including e-consult) is highly recommended prior to using linaclotide for IBS-C

For men: Intolerance or inadequate response to a 1-month trial of plecanatide (3 mg once daily), unless there is a contraindication or risk factor(s) for serious adverse event(s)
For women: Intolerance or inadequate response to a 1-month trial of lubiprostone (8 mcg twice daily), unless there is a contraindication or risk factor(s) for serious adverse event(s). Use of lubiprostone is off-label for IBS-C in men.

Examples of osmotic laxatives: lactulose, sorbitol, magnesium citrate, magnesium hydroxide, glycerin rectal suppositories
During the 1-month trial, escalation/titration of therapy up to bowel-prep doses of PEG-3350 may be considered case by case to achieve the desired response.