Linaclotide (Linzess) is the first approved treatment for functional constipation in pediatric patients ages six to 17 years. It is taken orally once daily.
Functional constipation is defined as difficult or infrequent bowel movements that deviate from normal frequency. Typically, it is not from an underlying anatomical defect or systemic cause, but from multiple factors including environmental conditions, stress, diet, coping skills, and social support. Functional constipation is frequently seen in preschool children during toilet training but may occur in any pediatric age group.1 It is a frequent childhood problem with a reported global prevalence ranging from 0.5% to 32.2%.2
Linaclotide is a guanylate cyclase-C agonist that was previously approved for treating irritable bowel syndrome with constipation and chronic idiopathic constipation in adults. Linaclotide and its active metabolite bind to receptors on the luminal surface of the intestinal epithelium. Stimulation of these receptors leads to increased secretion of chloride and bicarbonate into the intestinal lumen. The result is increased intestinal fluid and accelerated transit of waste through the gastrointestinal tract.
The efficacy of linaclotide in treating pediatric functional constipation was determined in a 12-week double-blind, placebo-controlled, randomized, multicenter clinical trial of 328 patients. The primary efficacy end point was a 12-week change from baseline in spontaneous bowel movement frequency. Patients who received linaclotide had a greater improvement in their bowel movement frequency than those who received placebo. The drug's effect was noted during the first week of treatment and continued throughout the 12-week treatment period.
Similar to when adults take linaclotide, children may experience diarrhea; this was the most common adverse effect observed during the clinical trial. Nausea, abdominal discomfort, and dehydration are also possible. Children under two years of age should not receive linaclotide because of a risk of severe dehydration.
Nurses should teach patients and their parents that the drug should be taken at least 30 minutes before a meal and that the capsule should be swallowed whole. If the child has trouble swallowing the capsule, its contents can be mixed in one teaspoon of room temperature applesauce or in 30 mL of room temperature bottled water. If using water, the contents should be swirled for at least 20 seconds and then taken immediately. Parents should keep the drug out of reach of children under the age of six years.
For complete prescribing information for linaclotide, go to http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202811s021lbl.pdf.
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