Additional trial findings

Patients suffering from Irritable Bowel Syndrome with Constipation (IBS-C) and Chronic Idiopathic Constipation (CIC) don’t want to wait for relief. LINZESS is a once-daily treatment that can allow patients to proactively manage their symptoms.1

Improvement in abdominal pain and CSBMs was seen at Week 1, with maximum effect on abdominal pain at Weeks 6-91

IBS-C Trials 1 and 2: time to maximum CSBM frequency and abdominal pain with LINZESS treatment1

  • This illustrative “line of best fit” graph depicts the time to maximum CSBM frequency and maximum abdominal pain improvement in trials evaluating LINZESS in adults with IBS-C (Trials 1 and 2)
  • In each IBS-C trial, maximum effect on CSBM frequency was reached within the first week of treatment with LINZESS and was maintained until the end of the trial
  • In each IBS-C trial, for change from baseline in the 11-point abdominal pain scale, LINZESS began to separate from placebo in the first week
    • Maximum effect on abdominal pain was seen at Weeks 6-9 of treatment with LINZESS and was maintained until the end of the study

In clinical trials, patients experienced reduced abdominal pain and more frequent CSBMs over the 12-week treatment period. During the 4-week randomized withdrawal period of Trial 1, LINZESS-treated patients re-randomized to placebo experienced a return in abdominal pain severity toward baseline within 1 week.1

IBS-C Trial 1: change in abdominal pain observed during the 4-week randomized withdrawal (RW) period1,21

  • This illustrative “line of best fit” graph depicts abdominal pain levels during the 4-week randomized withdrawal period in one trial evaluating LINZESS in adults with IBS-C (Trial 1)
  • During the 4-week randomized withdrawal period, patients who received LINZESS during the 12-week treatment period were re-randomized to receive placebo or continue treatment on LINZESS 290 mcg
  • DE: Patients on placebo who were allocated to LINZESS had decreases in abdominal pain levels that were similar to the levels observed in patients taking LINZESS during the treatment period
  • AB: Patients who continued on LINZESS maintained their response to therapy over the additional 4 weeks
  • AC: In LINZESS-treated patients re-randomized to placebo, abdominal pain levels returned towards baseline within 1 week and did not result in worsening compared with baseline

LINZESS-treated patients re-randomized to placebo experienced a decrease of CSBM frequency toward baseline within 1 week, while patients who continued on LINZESS maintained their response for the additional 4 weeks of the study.1

IBS-C Trial 1: change in CSBM frequency observed during the 4-week randomized withdrawal (RW) period1,21

  • This illustrative “line of best fit” graph depicts change in CSBM frequency during the 4-week randomized withdrawal period in one trial evaluating LINZESS in adults with IBS-C (Trial 1)
  • During the 4-week randomized withdrawal period, patients who received LINZESS during the 12-week treatment period were re-randomized to receive placebo or continue treatment on LINZESS 290 mcg
  • AB: Patients who continued on LINZESS maintained their response over the additional 4 weeks
  • DE: Patients on placebo who were allocated to LINZESS had increases in CSBM frequency that were similar to the levels observed in patients taking LINZESS during the treatment period
  • AC: In LINZESS-treated patients re-randomized to placebo, CSBM frequency returned towards baseline within 1 week and did not result in worsening compared with baseline

As this study shows, LINZESS is a treatment that patients with IBS-C can use to help them proactively manage their symptoms.1 LINZESS is the #1 prescribed brand by healthcare professionals for adults with IBS-C and CIC.1,19

Learn more about this 12-week randomized, placebo-controlled trial with a 4-week randomized withdrawal period of linaclotide in IBS-C
Overall Abdominal Symptoms Data
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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.