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linaclotide (Linzess)

Indications: - treatment of chronic constipation in patients >= 18 years - treatment of functional constipation in children >= 6 years [6] - treatment of irritable bowel syndrome with predominance of constipation [4] Dosage: - 145 ug PO QD, taken on an empty stomach, at least 30 minutes before the 1st meal of the day Capsule: 72 ug, 145 ug, 290 ug Storage: - store in orginal container - must be protected from moisture - original container has a desiccant [5] Adverse effects: - diarrhea (most common) Mechanism of action: - guanylate cyclase-C agonist [4] - chloride channel activator - increases chloride, bicarbonate & fluid secretion into the intestine, thus reducing fecal transit time - improves symptoms in some patients - number need to treat to benefit one patient = 5-8 [3]

General

laxative

Database Correlations

PUBCHEM correlations

References

  1. Lembo AJ et al Two Randomized Trials of Linaclotide for Chronic Constipation N Engl J Med 2011; 365:527-536 PMID: 21830967
  2. FDA News Release: Aug. 30, 2012 FDA approves Linzess to treat certain cases of irritable bowel syndrome and constipation http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm317505.htm
  3. Chey WD et al. Linaclotide for irritable bowel syndrome with constipation: A 26-week, randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety. Am J Gastroenterol 2012 Nov; 107:1702 PMID: 22986437 http://www.nature.com/ajg/journal/v107/n11/full/ajg2012254a.html - Rao S et al. A 12-week, randomized, controlled trial with a 4-week randomized withdrawal period to evaluate the efficacy and safety of linaclotide in irritable bowel syndrome with constipation. Am J Gastroenterol 2012 Nov; 107:1714. PMID: 22986440 http://www.nature.com/ajg/journal/v107/n11/full/ajg2012255a.html
  4. Prescriber's Letter 19(12): 2012 New Drug: Linzess (Linaclotide) Detail-Document#: 281204 (subscription needed) http://www.prescribersletter.com
  5. Prescriber's Letter 21(6): 2014 Oral Meds to Keep in Original Containers Detail-Document#: 300622 (subscription needed) http://www.prescribersletter.com
  6. Brooks M FDA Approves First Treatment for Constipation in Kids. Medscape. June 12, 2023 https://www.medscape.com/viewarticle/993074