Trulance is the only structural analog of human uroguanylin and is believed to replicate the pH-sensitive activity of uroguanylin^1-6

Uroguanylin activity modulates within the changing pH environment of the intestines, coinciding with areas of fluid secretion, and decreases pain sensation^1,6-8

Uroguanylin stimulates fluid secretion, thereby maintaining stool consistency necessary for regular bowel function^1,6

Based on pre-clinical studies. Clinical relevance of this data has not been established.

1ACTIVATES GC-C receptors in a pH-sensitive manner⁶

2Increases cGMP and regulates electrolyte homeostasis⁵

3Stimulates fluid secretion and facilitates bowel movements²

4Decreases the activity of pain-sensing nerves in the intestine^7,8

Watch Trulance in action

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 Box Warning, for additional risk information.

References:

Trulance [package insert]. New York, NY: Synergy Pharmaceuticals Inc., 2018.
Shailubhai K, Comiskey S, Foss JA, et al. Dig Dis Sci. 2013;58(9):2580-2586.
Amitiza [package insert]. Rockville, MD: Sucampo AG.
Linzess [package insert]. Cambridge, MA: Ironwood Pharmaceuticals, Inc.
DeMicco M, Barrow L, Hickey B, Shailubhai K, Griffin P. Therap Adv Gastroenterol. 2017;10(11):837-851.
Jiang C, Xu Q, Wen X, Sun H. Acta Pharm Sin B. 2015;5(4):300-309.
Hannig G, Tchemychev B, Kurtz CB, Bryant AP, Currie MG, Silos-Santiago I. Front Mol Neurosci. 2014:1-6 doi:10.3389/fnmol.2014.00031.
Silos-Santiago I, Hannig G, Eutamene H, et al. Pain. 2013;154(9):1820-1830.

Trulance is the only structural analog of human uroguanylin and is believed to replicate the pH-sensitive activity of uroguanylin1-6