Severe diarrhea was reported in 2% of 145 The incidence of diarrhea was similar in theĬIC populations. The safety and effectiveness of LINZESS in patients less than 18 years of age have not been established.ĭiarrhea was the most common adverse reaction in LINZESS-treated patients in the pooledĬIC double-blind placebo-controlled trials. There was no age-dependent trend in GC-C intestinal expression in a clinical study of children 2 to less than 18 years of age however, there are insufficient data available on GC-C intestinal expression in children less than 2 years of age to assess the risk of developing diarrhea and its potentially serious consequences in these patients. In neonatal mice, linaclotide increased fluid secretion as a consequence of age-dependent elevated GC-C agonism which was associated with increased mortality within the first 24 hours due to dehydration. LINZESS is contraindicated in patients less than 2 years of age. Warnings and Precautions Risk of Serious Dehydration in Pediatric Patients Less Than 2 Years of Age LINZESS is contraindicated in patients with known or suspected mechanical gastrointestinal LINZESS is contraindicated in patients less than 2 years of age due to the risk of serious dehydration.
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE 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. Linaclotide does not interact with the cytochrome P450 enzyme system based on the results of in vitro studies 1 Linaclotide and its active metabolite are not measurable in plasma following administration of the recommended clinical doses hence, no systemic drug-drug interactions or drug interactions mediated by plasma protein binding of linaclotide or its metabolite are anticipated 1 No drug-drug interaction studies have been conducted with LINZESS. Keep bottles tightly closed in a dry place 1 Do not remove desiccant from the container. It is important to keep LINZESS in the original container.
Store at 25☌ (77☏) excursions permitted between 15☌ and 30☌ (59☏ and 86☏). ‡ Source: IQVIA Monthly Total Prescriptions Volume data as of October 2021. LINZESS is the #1 prescribed branded treatment for IBS-C and CIC by gastroenterologists and primary care physicians ‡ LINZESS is the #1 prescribed branded treatment for IBS-C and CIC by gastroenterologists and primary care physicians ‡
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