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About your adult patients with Irritable Bowel Syndrome
with Constipation (IBS‑C)

DISEASE STATE OVERVIEW

Irritable Bowel Syndrome with Constipation (IBS‑C) is one of the 3 subtypes of IBS,7 a chronic functional GI disorder that arises from an abnormal functioning of the GI tract and not from structural or biochemical abnormalities.8  The other 2 subtypes of IBS are IBS with diarrhea (IBS‑D) and IBS with mixed bowel pattern (IBS‑M), which can vary between constipation and diarrhea.7

IBS‑C is defined as abdominal pain or discomfort that occurs in association with constipation.7 IBS‑C is associated with hard or lumpy stool consistency in at least 25% of bowel movements, and loose or watery stool consistency in less than 25% of bowel movements.7 In IBS‑C, symptoms are chronically present.8

In an Internet-based survey,* adult IBS‑C sufferers indicated that they often experience multiple symptoms, including constipation, abdominal pain, and incomplete evacuation. These symptoms occur frequently and can be severe in sufferers.4


Adults-with-IBSC-Prevalence-graphic
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Adult IBS-C Sufferers Reported Frequent Symptoms, Including Abdominal Pain and Constipation*4
Adults-with-IBSC-Symptoms
*
This Web-based survey was commissioned by Ironwood Pharmaceuticals, Inc. and Forest Laboratories, LLC 571 individuals qualified for the detailed survey after meeting Rome II, Rome III, or modified Manning criteria for IBS-C based on reponses to a symptom checklist.4
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Many Adult IBS-C Sufferers Reported Self-Treating with OTC Medications and Actively Seeking Physician Care*4
Adults-with-IBSC-Symptoms
*
This Web-based survey was commissioned by Ironwood Pharmaceuticals, Inc. and Forest Laboratories, LLC 571 individuals qualified for the detailed survey after meeting Rome II, Rome III, or modified Manning criteria for IBS-C based on reponses to a symptom checklist.4

IBS‑C: Pathophysiology

The exact cause of IBS‑C has not been identified. Instead, IBS‑C is considered to be a disorder resulting from the interaction of a number of factors.9 Potential factors include:

Visceral hypersensitivity
Visceral hypersensitivity is an enhanced responsiveness or perception within the intestine that can occur even in response to normal events.10,11 Sufferers may feel more pain than healthy individuals when their intestines are stimulated or stretched. Visceral hypersensitivity may also lead to changes in intestinal motility and secretion.12

Disturbance in water balance and GI tract motility
Colonic motility may be delayed in IBS‑C sufferers, which may be due to decreased contractions that move contents through the colon leading to infrequent defecation.9 Water imbalance may also occur due to the colon absorbing too much water, resulting in stools that are hard, dry, and difficult to pass.13,14

Brain‑gut dysfunction
IBS‑C patients may have altered brain‑gut communication leading to changes in motility, sensation, and secretion in the bowel.15

Additional possible causes of IBS‑C include local inflammation of GI tract, intestinal bacterial overgrowth, and psychological factors.9



TALKING TO PATIENTS ABOUT THEIR SYMPTOMS

Talking to sufferers can be a challenge. Many find their condition embarrassing to talk about and may not think to bring up multiple symptoms. Since IBS‑C is a multi‑symptom condition, additional prompting may be required.



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.