Download Trulance™ - plecanatide

New Drug Introduction: Trulance / plecanatide
Pharmacology
Manufacturer
Approval Date
Indication
Contraindications
Black Box Warnings
Warnings/
Precautions
Pregnancy
Lactation
Pharmacokinetics
Drug Interactions –
Object/Precipitant
Drug
Adverse Effects
(plecanatide) [placebo]
Monitoring Efficacy
Monitoring Toxicity
Dosing
Dosing – Maximum
Renal Adjustment
Hepatic Adjustment
Administration

Trulance™, plecanatide, is structurally related to human uroguanylin. It
functions as a guanylate cyclase-C agonist that acts locally on the
luminal surface of the intestinal epithelium.
Synergy Pharmaceuticals Inc.
January 19, 2017
Treatment of chronic idiopathic constipation (CIC) in adults
 Patients less than 6 years of age due to the risk of serious dehydration
 Patients with known or suspected mechanical gastrointestinal
obstruction
Risk of serious dehydration in pediatric patients
Diarrhea: Patients may experience severe diarrhea. If severe diarrhea
occurs, suspend dosing and rehydrate the patient.
Category B – Available data on use in pregnant women is not sufficient to
inform any drug-associated risks for major birth defects and miscarriage.
Animal developmental studies observed no risk on embryo-fetal
development with oral administration.
Lactation Recommendation: No information available
A – Minimally absorbed; AUC and Cmax cannot be calculated
D – Plecanatide concentrations following clinically relevant doses are not
measurable, thus, plecanatide is expected to be minimally distributed in
tissues
M – Metabolized in the GI tract to an active metabolite by low of the
terminal leucine moiety; both plecanatide and the metabolite are
proteolytically degraded within the intestinal lumen to smaller peptides and
naturally occurring amino acids
E – No excretion studies have been conducted in humans; plecanatide and
its active metabolite are not measurable in plasma following administration
of the recommended clinical doses.
 Neither plecanatide nor its active metabolite inhibited the CYP P450
enzymes 2C9 and 3A4, and they did not induce CYP3A4 in vitro.
 Plecanatide and its active metabolite are neither substrates nor
inhibitor of the transporters P-gp or BCRP in vitro.
Diarrhea (5%) [1%]
Frequency of bowel movements
No findings of toxicity observed in study
3 mg PO once daily
The maximum recommended human dose is approximately 0.05
mg/kg/day, based on a 60-kg body weight.
No adjustment necessary
No adjustment necessary
 Take with or without food.
 Swallow tablets whole.
 For adult patients with swallowing difficulties, Trulance™ tablets can be
crushed and administered either in applesauce or with water or
administered with water via a nasogastric or gastric feeding tube. The
use of crushed tablets has not been tested.
Cost: Lexicomp: Accessed 2/22/2016
Dose(s)
Brandor – Generic
Trulance™ - plecanatide
LinzessTM - linaclotide
AmitizaTM – lubiprostone
ZelnormTM – tegaserod
3 mg tablet
145 mcg capsule;
290 mcg capsule
8 mcg capsule;
24 mcg capsule
2 mg tablet;
6 mg tablet
$ (30 day supply)
Not yet available
$388
$396
$148
Summary

Trulance™, plecanatide, is a guanylate cyclase-C agonist indicated in adults for the
treatment of chronic idiopathic constipation (CIC)

Plecanatide is dosed by mouth as a once daily 3 mg tablet, which can be taken without
regard to food

The most common adverse effect is diarrhea, which typically occurs within 4 weeks of
treatment initiation. If severe diarrhea occurs, suspend dosing and rehydrate the
patient

Plecanatide contains a black box warning for risk of serious dehydration in pediatric
patients. For this reason, it is contraindicated in patients less than 6 years old. The
safety and effectiveness of plecanatide have not been established in patients less than
18 years old.

Plecanatide provides a new option for patients with CIC who have not found relief in
other medications
References:
1. www.trulancehcp.com
2. Trulance (plecanatide) [prescribing information]. New York, NY: Synergy
Pharmaceuticals Inc.; January 2017.
3. Miner PB Jr, Koltun WD, Wiener GJ, De La Portilla M, Prieto B, Shailubhai K, Layton
MB, Barrow L, Magnus L, Griffin PH. A randomized phase III clinical trial of
plecanatide, a uroguanylin analog, in patients with chronic idiopathic constipation. Am
J Gastroenterol 2017. doi: 10.1038/ajg.2015.611. [Epub ahead of print]
Date Prepared: 2/22/2016
Editor: Peter G. Koval, Pharm.D., BCPS
Author: Kristin Aloi, Pharm.D. Candidate, UNC Eshelman School of Pharmacy