IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
LINZESS is contraindicated in patients less than 6 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.
Use of
LINZESS should be avoided in
patients 6 years to less than 18 years of age. The safety and effectiveness of LINZESS have
not been
established in patients
less than 18 years of age.
Contraindications
-
LINZESS is contraindicated in patients less than 6 years of age due to the risk of serious
dehydration.
-
LINZESS is contraindicated in patients with known or suspected mechanical gastrointestinal
obstruction.
Warnings and Precautions
Pediatric Risk
-
LINZESS is contraindicated in patients less than 6 years of age. The safety and
effectiveness of
LINZESS in patients less than 18 years
of age have not been established. In neonatal mice, linaclotide increased fluid secretion as
a
consequence of GC-C agonism resulting
in mortality within the first 24 hours due to dehydration. Due to increased intestinal
expression of
GC-C, patients less than 6 years of
age may be more likely than patients 6 years of age and older to develop severe diarrhea and
its
potentially serious consequences.
-
Use of LINZESS should be avoided in pediatric patients 6 years to less than 18 years of age.
Although there were no deaths in older
juvenile mice, given the deaths in young juvenile mice and the lack of clinical safety and
efficacy
data in pediatric patients, use of
LINZESS should be avoided in pediatric patients 6 years to less than 18 years of age.
Diarrhea
-
Diarrhea was the most common adverse reaction in LINZESS-treated patients in the pooled
IBS-C and
CIC double-blind placebo-controlled trials. The incidence of diarrhea was similar in the
IBS-C and
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
patients.
If severe diarrhea occurs, dosing
should be suspended and the patient rehydrated.
Common Adverse Reactions (incidence ≥2% and greater than
placebo)
-
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
CIC
clinical 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
bowel
syndrome with
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 Allergan Medical Information at 1.800.678.1605.