Please see the full Prescribing Information, including boxed warning.

Review the 2020 American College of Gastroenterology (ACG) Clinical Guidance on Management of Irritable Bowel Syndrome

Review the 2020 American College of Gastroenterology (ACG) Clinical Guidance

Indication

Trulance (plecanatide) 3 mg tablets are 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.

Please see additional Important Safety Information below and please click here for full Prescribing Information.

Dear {{customText[Dr|Mr|Ms|Mrs]}} {{accLname}}, {{customText[I appreciate your time meeting with me today. I’ve included some information below that I mentioned earlier and I’d love to discuss in more detail when you are available.|I’m sorry we were not able to meet today. I am sharing some information I thought you would find interesting. I look forward to discussing this at your next availability.|I wanted to send you the information about ACG Clinical Guidelines. I’ll be sure we discuss this during our next conversation.]}}

The ACG Clinical Guideline gave Trulance a STRONG RECOMMENDATION with a HIGH QUALITY OF EVIDENCE for the treatment of global IBS-C symptoms as a GC-C agonist¹

•

Effective for relieving overall and individual symptoms of IBS‑C¹

•

Responses develop quickly and are maintained over time¹

•

Diarrhea is the most common adverse event experienced, but it was well-tolerated, and discontinuation rates due to diarrhea are low¹

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.'

Prescribe Trulance With Confidence

Examine some of the efficacy data from clinical trials that were evaluated by the ACG when making their recommendation involving Trulance.

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IMPORTANT SAFETY INFORMATION (continued)

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.

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Sincerely,

Reference: 1. Lacy BE, Pimentel M, Brenner DM, et al. ACG clinical guideline: management of irritable bowel syndrome. Am J Gastroenterol. 2021;116(1):17‑44.

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Indication

The ACG Clinical Guideline gave Trulance a STRONG RECOMMENDATION with a HIGH QUALITY OF EVIDENCE for the treatment of global IBS-C symptoms as a GC-C agonist1

Prescribe Trulance With Confidence

Want to learn more? Speak with a rep!

The ACG Clinical Guideline gave Trulance a STRONG RECOMMENDATION with a HIGH QUALITY OF EVIDENCE for the treatment of global IBS-C symptoms as a GC-C agonist¹

Want to learn more?
Speak with a rep!