PLECANATIDE TAB,ORAL
Clinical Criteria Summary
Document 764
Exclusion Criteria
- Mechanical gastrointestinal obstruction, known or suspected
- Age less than 18 years
- Presence of severe or frequent diarrhea
- Chronic constipation due to drug-induced causes, neurogenic disorders, or non-neurogenic disorders (excluded from IBS definition)
Inclusion Criteria
- Men or women 18 years or older with a documented diagnosis of irritable bowel syndrome with constipation (IBS-C)
- 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 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)
Additional Clinical Recommendations & Notes
- GI consultation (including e-consult) is highly recommended prior to using plecanatide for IBS-C
- Osmotic laxatives include lactulose, sorbitol, magnesium citrate, magnesium hydroxide, and glycerin rectal suppositories
- Escalation/titration of therapy up to bowel-prep doses of PEG-3350 may be considered case by case during the 1-month trial
Document 765
Indication
- Chronic idiopathic constipation (CIC)
- Note: CIC excludes drug-induced chronic constipation and chronic constipation due to neurogenic and non-neurogenic disorders.
Exclusion Criteria
- Mechanical gastrointestinal obstruction, known or suspected
- Age less than 18 years
- Presence of severe or frequent diarrhea
Inclusion Criteria & Prerequisites
- Men or women 18 years or older with 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)
Laxative Trial Specifications
- 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
Consultation Recommendations
- GI consultation (including e-consult) is highly recommended prior to using plecanatide for CIC.