NEXT:
Next Page Goes Here
LINZESS (linaclotide) is indicated in adults for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).

Important Safety Information

WARNING: PEDIATRIC RISK
LINZESS is contraindicated in pediatric patients up to 6 years of age. Use should be avoided in pediatric patients 6 through 17 years of age. In nonclinical studies, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths in young juvenile mice.

Contraindications

  • LINZESS is contraindicated in pediatric patients up to 6 years of age.
  • LINZESS is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.

WARNINGS AND PRECAUTIONS

Pediatric Risk

  • LINZESS is contraindicated in pediatric patients up to 6 years of age. In nonclinical studies, deaths occurred within 24 hours in young juvenile mice (1 to 3 week‑old mice; approximately equivalent to human pediatric patients less than 2 years of age) following administration of one or two daily oral doses of linaclotide.
  • Use of LINZESS should be avoided in pediatric patients 6 through 17 years of age. Linaclotide did not cause deaths in older juvenile mice (approximately equivalent to humans age 12 to 17 years). 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 through 17 years of age.

Diarrhea

  • Diarrhea was the most common adverse reaction of LINZESS‑treated patients in the pooled IBS‑C and CIC double‑blind placebo‑controlled trials. Severe diarrhea was reported in 2% of LINZESS‑treated patients. The incidence of diarrhea was similar in the IBS‑C and CIC populations.
  • Patients should be instructed to stop LINZESS if severe diarrhea occurs and to contact their healthcare provider, who should consider dose suspension.

ADVERSE REACTIONS

  • In IBS‑C clinical trials, the most common adverse reactions in LINZESS‑treated patients (incidence ≥2% and greater than placebo) were 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 clinical trials, the most common adverse reactions in LINZESS‑treated patients (incidence ≥2% and greater than placebo) were 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%).
Please also see the full Prescribing Information for LINZESS.
You are now leaving www.LinzessHCP.com

Thank you for visiting www.LinzessHCP.com. You are now being redirected to an external site.

References
  1. LINZESS (linaclotide) [prescribing information]. St. Louis, MO:Forest Pharmaceuticals, Inc.; 2012.
  2. Chey WD, Lembo AJ, Lavins BJ, et al. Linaclotide for irritable bowel syndrome with constipation: a 26-week, randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety. Am J Gastroenterol. 2012;107:1702-1712.
  3. Rao S, Lembo AJ, Shiff SJ, et al. A 12-week, randomized, controlled trial with a 4-week randomized withdrawal period to evaluate the efficacy and safety of linaclotide in irritable bowel syndrome with constipation. Am J Gastroenterol. 2012;107:1714-1724.
  4. Data on file. Forest Laboratories, Inc.
  5. Lembo AJ, Schneier HA, Shiff SJ, et al. Two randomized trials of linaclotide for chronic constipation. N Engl J Med. 2011;365(6):527-536.
  6. Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F and Spiller RC. Functional bowel disorders. Gastroenterology. 2006;130:1480-1491.
  7. Brandt LJ, et al. An Evidence-Based Systematic Review on the Management of Irritable Bowel Syndrome American College of Gastroenterology Task Force on IBS. Am J Gastroenterol. 2009; 104 (1): S1-S35.
  8. Andrews EB, Eaton, SC, Hollis KA. Prevalence and demographics of irritable bowel syndrome: results from a large web-based survey. Ailment Pharmacol Ther 2005; 22: 935-942.
  9. Feldman M, Friedman LS, Brandt LJ. Sleisenger and Fordtran’s Gastrointestinal and Liver Disease: Pathophysiology/Diagnosis/Management. 9th ed. Philadelphia, PA: Saunders Elsevier; 2010.
  10. Delvaux M. Role of visceral sensitivity in the pathophysiology of irritable bowel syndrome. Gut 2002;51(suppl I):i67–i7.
  11. Wald A, Talley NJ and Grover S. Pathophysiology of irritable bowel syndrome. Available at: http://www.uptodate.com/contents/pathophysiology-of-irritable-bowel-syndrome?view=print. Updated September 24, 2012. Accessed October 2, 2012.
  12. Karantanos T, Markoutsaki T, Gazouli M, Anagnou NP and Karamanolis DG. Current insights into the pathophysiology of Irritable Bowel Syndrome. Gut Pathog. 2010;2:3.
  13. NDDIC: NIH Publication. Constipation. NIH Publication No. 07–2754. July 2007.
  14. Tortora GJ, Derrickson B. Principles of Anatomy and Physiology. 13th ed. Hoboken, NJ: John Wiley and Sons, Inc.; 2012.
  15. Chang L and Drossman DA. Irritable bowel syndrome (IBS). 2010. International Foundation for Functional Gastrointestinal Disorder.www.iffgd.org. Accessed October 1, 2012.
  16. Brandt LJ, Prather CM, Quigley EMM, Schiller LR, Schoenfeld P, Talley NJ. Systematic review on the management of chronic constipation in North America. Am J Gastroenterol. 2005;100(100):S1-S21.
  17. U.S. Census Bureau, Statistical Abstract of the United States: 2012.
  18. Velio P, Bassotti G. Chronic idiopathic constipation: pathophysiology and treatment. J Clin Gastroenterol. 1996;22:190-196.
  19. Johanson JF, Kralstein J. Chronic constipation: a survey of the patient perspective. Aliment Pharmacol Ther. 2007;25:599–608.
For Patients

The information contained in this Web site is intended for United States citizens only. I certify that I am a citizen of the United States.

WHO WOULD YOU LIKE TO SHARE THIS WITH?

By submitting an email address, you are requesting that we contact the person you specify below on your behalf. Your contact information and recipient's contact information are required, but this information will not be retained or used other than to send your message about LINZESS™ (linaclotide).

All fields are required.

Thank you. Your email has been sent.