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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 under 6 years of age. In nonclinical studies, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration in young juvenile mice. Use of LINZESS should be avoided in pediatric patients 6 through 17 years of age. The safety and efficacy of LINZESS has not been established in pediatric patients under 18 years of age.

Contraindications

  • LINZESS is contraindicated in pediatric patients under 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 under 6 years of age. The safety and effectiveness of LINZESS in pediatric patients under 18 years of age have not been established. In neonatal mice, increased fluid secretion as a consequence of GC-C agonism resulted in mortality within the first 24 hours due to dehydration. Due to increased intestinal expression of GC-C, children under 6 years of age may be more likely than older children and adults to develop significant diarrhea and its potentially serious consequences.
  • Use of LINZESS should be avoided in pediatric patients 6 through 17 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 through 17 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. 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. The healthcare provider should consider dose suspension and rehydration.

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.
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References
  1. LINZESS (linaclotide) [prescribing information]. St. Louis, MO: Forest Pharmaceuticals, Inc.; 2015.
  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, LLC
  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. Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997;32:920-924.
  7. Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology. 2006;130:1480-1491.
  8. 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.
  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–i71.
  11. Wald A, Talley NJ, Grover S. Pathophysiology of irritable bowel syndrome. Available at: http://www.uptodate.com/contents/pathophysiology-of-irritable-bowel-syndrome?view=print. Updated May 7, 2013. Accessed June 21, 2013.
  12. Karantanos T, Markoutsaki T, Gazouli M, Anagnou NP, 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, 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(Supp 1):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.
For Patients

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PROGRAM RULES AND ELIGIBILITY
REQUIREMENTS FOR PATIENTS:
The LINZESS® Instant Savings Program is applicable ONLY when accompanied by a valid prescription for LINZESS (linaclotide) capsules 145 mcg or 290 mcg. Offer is valid toward out-of-pocket expense for commercially insured eligible patients and cash-paying patients. If the total out-of-pocket cost exceeds $105, the patient will be responsible for $30 plus any additional amount over $105. If the copay is $30 or less, this offer does not apply. Offer valid in the U.S. only. Offer not valid for prescriptions reimbursed under Medicaid, a Medicare drug benefit plan, or other federal or state healthcare programs (such as medical assistance programs), or where the patient has secondary coverage for out-of-pocket expenses. If the patient is eligible for drug benefits under any such program, the patient cannot use this offer. By using this offer, the patient certifies that he or she meets the eligibility criteria and will comply with any terms of his or her health insurance contract requiring notification to his or her payor of the existence and/or value of this coupon. Any step edits or prior authorizations required by the insurance plan still apply. Offer not valid for patients under 18 years of age. It is illegal to (or offer to) sell, purchase, or trade the coupon. This program includes automatic savings and use of the LINZESS Instant Savings coupon. Automatic savings are not extended on prescriptions for patients who are cash-paying customers, prescriptions filled by mail order pharmacies, and prescriptions filled at non-participating pharmacies. The LINZESS Instant Savings coupon may be used for cash-paying customers and commercially insured eligible patients using non-participating pharmacies. Patients using the LINZESS Instant Savings coupon must present the coupon each time a prescription for LINZESS is presented at the pharmacy. This program expires 02/01/2014. This offer is not transferable and is limited to one offer per person. Void where prohibited by law. Forest Laboratories, Inc. and Ironwood Pharmaceuticals, Inc. reserve the right to change or end this program at any time without notice. This is not insurance.