Most common adverse reactions and related risk information1

LINZESS was evaluated in 4 Phase 3 placebo‑controlled trials involving more than 2800 adults with IBS‑C and CIC1

*“Abdominal pain” term includes the preferred terms: abdominal pain, upper abdominal pain, and lower abdominal pain.1

  • In Trial 5, adverse reactions that occurred at a frequency of ≥2% in LINZESS 72 mcg–treated patients (n=411) and at a higher rate than placebo (n=401) were:
    • Diarrhea (LINZESS 72 mcg 19%, LINZESS 145 mcg 22%, placebo 7%)
    • Abdominal distension (LINZESS 72 mcg 2%, LINZESS 145 mcg 1%, placebo <1%)
  • Diarrhea was the most commonly reported adverse reaction of LINZESS1
    • In placebo-controlled clinical trials, 2% of the IBS-C patients treated with LINZESS and less than 1% of the 72 mcg LINZESS–treated CIC patients and 2% of the 145 mcg LINZESS–treated CIC patients reported severe diarrhea vs less than 1% in patients receiving placebo
    • The majority of reported cases of diarrhea started within the first 2 weeks of LINZESS treatment
    • In post-marketing experience, severe diarrhea associated with dizziness, syncope, hypotension, and electrolyte abnormalities (hypokalemia and hyponatremia) requiring hospitalization or intravenous fluid administration have been reported in patients treated with LINZESS
    • If severe diarrhea occurs, suspend dosing and rehydrate the patient
  • The incidence of discontinuation due to adverse reactions in IBS-C was 9% of patients treated with LINZESS compared with 3% of patients treated with placebo (Trials 1 and 2). In CIC, 3% of patients treated with 72 mcg LINZESS (Trial 5) and between 5% (Trial 5) to 8% (Trials 3 and 4) of patients treated with 145 mcg LINZESS discontinued due to adverse reactions compared with less than 1% (Trial 5) to 4% (Trials 3 and 4) of placebo-treated patients1
    • In the LINZESS treatment group, the most common reasons for discontinuation due to adverse reactions were diarrhea (5% in IBS-C and in CIC 2% [72 mcg LINZESS] and 3% to 5% [145 mcg LINZESS]) and abdominal pain (1% in IBS-C and 1% in 145 mcg LINZESS). In comparison, less than 1% of all placebo patients withdrew due to diarrhea or abdominal pain

    • Please see below and full Prescribing Information, including Boxed Warning, for additional risk information.

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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.

Contraindications

  • 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 obstruction.

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

  • 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 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 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.

IMPORTANT SAFETY INFORMATION

More
 

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.

Contraindications

  • 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 obstruction.

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

  • 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 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 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.