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For adults with irritable bowel syndrome with constipation (IBS-C)1

Help Address the Symptoms of IBS-C With the Relief of Trulance

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For adults with irritable bowel syndrome with constipation (IBS-C)1

Help Address the Symptoms of IBS-C With the Relief of Trulance

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

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In clinical trials of adults with IBS-C

There was a significantly greater percentage of efficacy responders in the Trulance group vs the placebo group1,2

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).1,2,b

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regular, well-formed BOWEL MOVEMENTS1–3,c

LESS IBS-C related

IBS-C related abdominal PAIN and BLOATING1,3,d

bIn 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 score of worst abdominal pain in the past 24 hours [measured daily] of ≥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).1,2

cIn 12-week clinical studies, more Trulance-treated patients had improvements in stool frequency (as measured by increased CSBMs, 21–48% Trulance vs 10–35% placebo) and consistency of bowel movements (as measured by mean increase in BSFS score, 1.5 Trulance vs 0.8–0.9 placebo).1,2,4,5

dAbdominal pain and constipation were components of the primary endpoint. Mean change from baseline in abdominal symptoms, including bloating, were measured as a secondary endpoint over 12 weeks in Phase III registrational trials. In clinical studies, more Trulance-treated patients were IBS-C abdominal pain responders (33–41%) compared to placebo (23–32%). Greater improvements in mean bloating score were also seen with Trulance (0.5–1.5) as compared to placebo (0.4–1.1).1,2,4,5

Strong recommendation from ACG Clinical Guideline6

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

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The 2020 American College of Gastroenterology (ACG) Clinical Guideline gave Trulance, as a guanylate cyclase-C (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

*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,e commercially insured patients may have a copay as low as $25 for up to a 90-day supply

Examine data from
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See the Trulance clinical trial results for IBS-C and CIC

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ePatient 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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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. Avoid use of TRULANCE in patients 6 years to less than 18 years of age. The safety and effectiveness of TRULANCE have not been established in patients less than 18 years of age.

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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. Avoid use of TRULANCE in patients 6 years to less than 18 years of age. The safety and effectiveness of TRULANCE have not been established in 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 into the intestines 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.
  • Avoid the use of TRULANCE 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, avoid the use of TRULANCE 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, 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).

To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Please click here for full Prescribing Information for Trulance, including BOXED WARNING.

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