For adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC)

ELEVATE THEIR EXPERIENCE

Help your adult patients with IBS-C or CIC reach symptom relief

In clinical trials of CIC and IBS-C, there was a significantly greater percentage of efficacy responders in the Trulance group vs the placebo group1-3*

Please see study designs below.

MORE regular, well-formed bowel movements1-3

In CIC patients:

  • Trulance significantly improved mean change in complete spontaneous bowel movement (CSBM) frequency to 2.5 per week vs 1.2 per week for placebo (P<0.001)2
  • Trulance significantly improved spontaneous bowel movement (SBM) frequency from 2 per week to more than 5 per week (P<0.001)1,4
  • Significantly more CIC patients experienced CSBMs and SBMs within 24 hours vs placebo (P<0.001)2
  • Consistent and significant improvements in stool consistency were demonstrated with a mean Bristol Stool Form Scale (BSFS) score of 4 (P<0.001)2

In IBS-C patients:

  • Consistent and significant improvements in stool consistency vs placebo (P<0.001)3

LESS IBS-C-related abdominal pain1,3

  • Significant reduction in abdominal pain in IBS-C vs placebo (P≤0.05)

Trulance established safety across two indications1

LOW incidence of diarrhea1

  • Treatment-related diarrhea was observed in ≤5% of patients1
    • Incidence of diarrhea was 5% vs 1% with placebo in CIC, and 4.3% vs 1% with placebo in IBS-C
  • No additional adverse events (AEs) occurred at an incidence of ≥2% in patients and were greater than placebo1

*Studied in more than 3,100 patients across 4 double-blind, placebo-controlled, 12-week studies1

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CIC Study Design

Trulance was studied in two 12-week, double-blind, placebo-controlled, randomized, multicenter clinical studies in 1,775 adult patients who met Rome III criteria for CIC and were randomized 1:1 to either placebo (n=892) or Trulance 3 mg (n=883) once daily without respect to food. Efficacy was assessed using information provided by patients on a daily basis in an electronic diary.

Primary Endpoint: A responder was defined as a patient who had at least 3 CSBMs in a given week and an increase of at least 1 CSBM from baseline in the same week for at least 9 weeks out of the 12-week treatment period and at least 3 of the last 4 weeks of the study.1

IBS-C Study Design

Trulance was studied in two 12-week, double-blind, placebo-controlled, randomized, multicenter clinical studies in 1,453 adult patients who met Rome III criteria for IBS-C and received placebo (n=729) or Trulance 3 mg (n=724) once daily without respect to food. Efficacy was assessed using information provided by patients on a daily basis through an electronic phone diary system.

Primary Endpoint: A responder was defined as a patient who met both the abdominal pain intensity and stool frequency responder criteria in the same week for at least 6 of the 12 treatment weeks, which were defined as an abdominal pain intensity responder (a patient who experienced a decrease in the weekly average score of worst abdominal pain in the past 24 hours [measured daily] of at least 30% compared to weekly baseline average) and a stool frequency responder (a patient who experienced an increase of at least 1 CSBM per week from baseline).1

Indication

Trulance (plecanatide) 3 mg tablets is indicated in adults for the treatment of Chronic Idiopathic Constipation (CIC) and Irritable Bowel Syndrome with Constipation (IBS-C).

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
Trulance® is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile mice administration of a single oral dose of plecanatide caused deaths due to dehydration. Use of Trulance should be avoided in patients 6 years to less than 18 years of age. The safety and efficacy of Trulance have not been established in pediatric patients less than 18 years of age.

 

Contraindications
  • Trulance is contraindicated in patients less than 6 years of age due to the risk of serious dehydration.
  • Trulance is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
Warnings and Precautions
Risk of Serious Dehydration in Pediatric Patients
  • Trulance is contraindicated in patients less than 6 years of age. The safety and effectiveness of Trulance in patients less than 18 years of age have not been established. In young juvenile mice (human age equivalent of approximately 1 month to less than 2 years), plecanatide increased fluid secretion as a consequence of stimulation of guanylate cyclase-C (GC-C), resulting in mortality in some mice within the first 24 hours, apparently due to dehydration. Due to increased intestinal expression of GC-C, patients less than 6 years of age may be more likely than older patients to develop severe diarrhea and its potentially serious consequences.
  • Use of Trulance should be avoided in patients 6 years to less than 18 years of age. Although there were no deaths in older juvenile mice, given the deaths in young mice and the lack of clinical safety and efficacy data in pediatric patients, use of Trulance should be avoided in patients 6 years to less than 18 years of age.
Diarrhea
  • Diarrhea was the most common adverse reaction in the four placebo-controlled clinical trials for CIC and IBS-C. Severe diarrhea was reported in 0.6% of Trulance-treated CIC patients, and in 1% of Trulance-treated IBS-C patients.
  • If severe diarrhea occurs, the health care provider should suspend dosing and rehydrate the patient.
Adverse Reactions
  • In the two combined CIC clinical trials, the most common adverse reaction in Trulance-treated patients (incidence ≥2% and greater than in the placebo group) was diarrhea (5% vs 1% placebo).
  • In the two combined IBS-C clinical trials, the most common adverse reaction in Trulance-treated patients (incidence ≥2% and greater than in the placebo group) was diarrhea (4.3% vs 1% placebo).

Please also see the full Prescribing Information, including BOXED Warning, for additional risk information.