bannerhome image Trulance® (plecanatide)

For adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC)2

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SEE TRULANCE CLINICAL DATA

aMean change from baseline in abdominal symptoms including bloating were measured as a secondary endpoint over 12 weeks in phase III registrational trials.

bIQVIA SMART NPA Monthly 09/2022.

Read the recommendation for Trulance

In clinical trials of adult patients with IBS-C and CIC

There was a significantly greater percentage of efficacy responders in the Trulance group vs the placebo group1-4

In Study 3 of IBS-C patients, the percentage of overall efficacy responders (abdominal pain and stool frequency) was 30% for Trulance vs 18% for placebo (P<0.001).2,3,c In Study 1 of CIC patients, the percentage of overall efficacy responders (durable complete spontaneous bowel movement) was 21% for Trulance vs 10% for placebo (P<0.005).2

MORE

regular, well-formed bowel movements2-5

LESS

IBS-C–related
abdominal pain

LOW

incidence of
diarrhea (≤5%)2

cIn Study 3 of IBS-C patients, 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 of worst abdominal pain in the past 24 hours score [measured daily] of at least 30% compared to weekly baseline average) and stool frequency responder (a patient who experienced an increase of at least 1 complete spontaneous bowel movement per week from baseline).2 In Study 1 of CIC patients, a responder was defined as a patient who had at least 3 complete spontaneous bowel movements in a given week and an increase of at least 1 complete spontaneous bowel movement 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.2

Strong recommendation
from the ACG Clinical Guidelines6

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The 2020 American College of Gastroenterology (ACG) Clinical Guideline gave Trulance, as a GC-C agonist, a strong recommendation with a high quality of evidence for the treatment of global IBS-C symptoms6:

  • Effective for relieving overall and individual symptoms of IBS-C
  • Responses develop quickly and are maintained over time
  • Diarrhea is the most common adverse event experienced, but it is well tolerated, and discontinuation rates due to diarrhea are low

GC-C, guanylate cyclase-C.

Strength of recommendation: Strong=Most patients should receive the recommended course of action. Quality of evidence: High=The estimate of effect is unlikely to change with new data.6

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Eligible,d commercially insured patients may have a copay as low as $25 for up to a 90-day supply
Examine data from
4 clinical trials >
See the Trulance clinical trial results for IBS-C and CIC.
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dPatient is not eligible if he/she participates in, seeks reimbursement or submits a claim for reimbursement to any federal or state healthcare program with prescription drug coverage, such as Medicaid, Medicare, Medigap, VA, DOD, TRICARE, or any similar federal or state healthcare program (each a Government Program), or where prohibited by law. Patient must be enrolled in, and must seek reimbursement from or submit a claim for reimbursement to, a commercial insurance plan. Offer excludes full-cash–paying patients. Maximum benefits and other restrictions apply. Visit Trulance.com/savings for full eligibility criteria, terms, and conditions.

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FASTEST-GROWING GC-C AGONIST PRESCRIBED FOR IBS-C AND CIC1,b

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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.