There was no age-dependent trend in GC-C intestinal expression in a clinical study of children 2 to <18 years of age there are insufficient data available on GC-C intestinal expression in children aged <2 years to assess the risk of developing diarrhea and its potentially serious consequences in these patients. In neonatal mice, fluid secretion increased because of GC-C agonism resulting in mortality within the first 24 hr due to dehydration. Contraindicated in patients <2 years of age. 
Known or suspected mechanical gastrointestinal obstruction Cautions Pediatric risk Patients aged <2 years due to risk of serious dehydration In nonclinical studies in neonatal mice, oral administration of a single, clinically relevant adult dose of linaclotide caused deaths due to dehydration Contraindications
LINZESS 145 MCG CAPSULE TRIAL
In a CIC trial of a 72 mcg dose: diarrhea (19% vs 7% placebo) and abdominal distension (2% vs <1%).Risk of serious dehydration in pediatric patientsĬontraindicated in pediatric patients aged <2 years
In CIC trials of a 145 mcg dose: diarrhea (16% vs 5% placebo), abdominal pain (7% vs 6%), flatulence (6% vs 5%), upper respiratory tract infection (5% vs 4%), sinusitis (3% vs 2%) and abdominal distension (3% vs 2%). In IBS-C clinical trials: diarrhea (20% vs 3% placebo), abdominal pain (7% vs 5%), flatulence (4% vs 2%), headache (4% vs 3%), viral gastroenteritis (3% vs 1%) and abdominal distension (2% vs 1%). If severe diarrhea occurs, dosing should be suspended and the patient rehydrated.Ĭommon Adverse Reactions (incidence ≥2% and greater than placebo) Severe diarrhea was reported in 2% of 145 mcg and 290 mcg LINZESS-treated patients, and in <1% of 72 mcg LINZESS-treated CIC patients. The incidence of diarrhea was similar in the IBS-C and CIC populations. Diarrhea was the most common adverse reaction in LINZESS-treated patients in the pooled IBS-C and CIC double-blind placebo-controlled trials. The safety and effectiveness of LINZESS in patients less than 18 years of age have not been established. 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 obstruction. 
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.
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