Constella (linaclotide) now approved for treating functional constipation in children

Health Canada has approved a new therapeutic use for AbbVie’s Constella (linaclotide capsules). The product is now indicated for the treatment of functional constipation in children six to 17 years of age. Linaclotide is also indicated for use in the treatment of irritable bowel syndrome with constipation (IBS-C) in adults and chronic idiopathic constipation in adults.1 The recommended dosage of linaclotide for the treatment of functional constipation in children six to 17 years of age is one 72 µg capsule, taken once daily on an empty stomach, at least 30 minutes before a meal. If children are unable to swallow the capsules whole, the capsules can be opened and administered orally in applesauce or with water, or administered with water via a nasogastric or gastric tube; detailed instructions are provided in the product monograph.1 Functional constipation is a common condition in children. It is characterized by hard, infrequent bowel movements that can be difficult or painful to pass, and often accompanied by fecal incontinence. The underlying cause in most children is unknown, but multiple factors, such as withholding defecation, may contribute to the disorder.2,3 First-line treatments for functional constipation include normal fibre and fluid intake, increased physical activity and a good toileting routine (see reference 3 for further guidance). If these treatments are ineffective, osmotic laxatives (e.g., polyethylene glycol 3350) should be tried.2,3 Stimulant laxatives, stool softeners and probiotics are other possible options.2 Linaclotide, a guanylate cyclase-C receptor agonist, stimulates the secretion of chloride and bicarbonate into the intestinal lumen, which increases intraluminal fluid and accelerates gastrointestinal transit. It is minimally absorbed following oral administration.2The efficacy of linaclotide for the treatment of functional constipation in children was established in a 12-week double-blind, placebo-controlled, randomized clinical trial. The trial included 328 children (6–17 years of age) with functional constipation who were randomized to receive linaclotide 72 µg or placebo once daily. At week 12, the mean increase from baseline in the number of spontaneous bowel movements per week was statistically significantly greater with linaclotide compared to placebo (2.6 vs 1.3). Improvements were seen during the first week of treatment and were maintained throughout the 12-week treatment period.The most common adverse effect of linaclotide in children with functional constipation is diarrhea (4% linaclotide vs 2% placebo); the drug should be stopped if severe diarrhea occurs.1,2 In Canada , Constella is contraindicated in children under six years of age because it has the potential to cause severe dehydration.1 Medical Letter consultants consider linaclotide to be modestly more effective than placebo in increasing the number of spontaneous bowel movements per week in children with functional constipation. They prefer the use of osmotic and/or stimulant laxatives first, which cost much less.2References:AbbVie Corporation. Constella (linaclotide capsules) product monograph. St-Laurent, QC; September 5, 2024. (accessed October 1, 2024).Anon. Linaclotide (Linzess) for functional constipation. Med Lett Drugs Ther 2023;65:135-6.Khafagy R. Managing constipation in pediatric patients. Canadian Healthcare Network, December 22, 2022. (accessed October 1, 2024).

Constella (linaclotide) now approved for treating functional constipation in children

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