IMPORTANT SAFETY INFORMATION
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.
LINZESS is contraindicated in patients less than 2 years of age due to the risk of serious dehydration.
LINZESS is contraindicated in patients with known or suspected mechanical gastrointestinal
Warnings and Precautions
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 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. 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. The safety and effectiveness of LINZESS in patients less than 18 years of age have not been established.
Diarrhea was the most common adverse reaction in LINZESS-treated patients in the pooled
CIC double-blind placebo-controlled trials. The incidence of diarrhea was similar in the
CIC populations. Severe diarrhea was reported in 2% of 145
mcg and 290 mcg LINZESS-treated patients, and in <1% of 72 mcg LINZESS-treated CIC
If severe diarrhea occurs, dosing
should be suspended and the patient rehydrated.
Common Adverse Reactions (incidence ≥2% and greater than
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%).
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 a
trial of a 72 mcg dose: diarrhea
(19% vs 7% placebo) and abdominal distension (2% vs <1%).
LINZESS® (linaclotide) is indicated in adults for the treatment of both irritable
constipation (IBS‑C) and chronic
idiopathic constipation (CIC).
If you are a patient, and have any questions, please discuss them with your doctor or healthcare
professional. For additional information
about LINZESS, call AbbVie Medical Information at 1-800-678-1605.
Please see additional Important Safety Information throughout, including Boxed Warning.
Please see full Prescribing Information, including Boxed Warning, or visit https://www.rxabbvie.com/pdf/linzess_pi.pdf.