From the Guidelines
Linzess (linaclotide) is approved for adults aged 18 and older and is not recommended for pediatric patients under 18 years of age. This medication treats irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in adults. The typical dosing ranges from 72 to 290 mcg taken once daily on an empty stomach, at least 30 minutes before the first meal of the day.
Key Points
- Linzess works by increasing intestinal fluid secretion and accelerating intestinal transit, which helps relieve constipation 1.
- It should never be given to children under 6 years due to serious safety concerns, as studies in young juvenile mice showed increased fluid secretion that resulted in deaths.
- For adolescents between 6-17 years, alternative constipation treatments should be discussed with a healthcare provider.
- Common side effects include diarrhea, abdominal pain, and flatulence, which typically occur within the first two weeks of treatment 1.
Important Considerations
- Linaclotide is contraindicated in individuals with known or suspected mechanical GI obstruction 1.
- The use of linaclotide might be associated with diarrhea leading to discontinuation or dose reduction; however, this was not very common 1.
- There were no clear differences in outcomes among individuals older than 65 years in clinical trials, although the sample size was too small to support formal analysis on differences in outcomes related to age 1.
From the FDA Drug Label
LINZESS is contraindicated in patients less than 2 years of age; in nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.4)]. The safety and effectiveness of LINZESS for the treatment of FC in pediatric patients 6 to 17 years of age have been established. The safety and effectiveness of LINZESS in patients with FC less than 6 years of age or in patients with IBS-C less than 18 years of age have not been established.
The age limitation for Linzess medicine is that it is contraindicated in patients less than 2 years of age due to the risk of serious dehydration. It is approved for use in pediatric patients 6 to 17 years of age for the treatment of functional constipation (FC). However, its safety and effectiveness have not been established in patients with FC less than 6 years of age or in patients with IBS-C less than 18 years of age 2.
From the Research
Linzess Medicine Age Limitation
- The provided studies do not explicitly mention an age limitation for the use of Linzess (linaclotide) medicine 3, 4, 5, 6, 7.
- However, the studies mention that linaclotide is approved for treating irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in adults 4, 5.
- The studies do not provide information on the use of linaclotide in pediatric patients, suggesting that it may not be recommended for children 3, 4, 5, 6, 7.
- It is essential to consult the prescribing information and consult with a healthcare professional to determine the appropriate use of linaclotide in different age groups 4, 5.
Efficacy and Safety of Linaclotide
- Linaclotide has been shown to be effective in treating IBS-C and CIC in adults, with improvements in bowel function, abdominal pain, and overall symptom severity 3, 4, 5, 6, 7.
- The most common adverse event associated with linaclotide is diarrhea, which can be mild to moderate in severity 4, 5, 7.
- The safety and tolerability of linaclotide have been evaluated in several studies, with no significant concerns identified 5.