A powerful cleansing prep with comparable and reliable efficacy1,2
Overall colon:
successful cleanse achieved1,2
mITT: P=.528
2-Day Split-Dosing
Patients, %
PP: P=.600
2-Day Split-Dosing
Patients, %
NOCT Trial Study Design: Randomized, multicenter, colonoscopist/central reader-blinded phase 3 noninferiority study assessed the bowel-cleansing efficacy, safety, and tolerability of PLENVU® vs Suprep in 556 adults on a 2-day split-dosing regimen using the validated Harefield Cleansing Scale (HCS).1,2
The HCS criteria are applied after precleaning of the colon3
- Successful Cleansing: Grade A or B. Grade A, there must be full visibility of the entire bowel mucosa before precleaning. Grade B, all 5 bowel segments must contain only brown liquid/fully removable semisolid stools, clear liquid, or be empty and clean
- High-Quality Cleansing: Defined as “excellent” or “good.” Excellent rating, the bowel segment must be empty and clean. Good rating, the bowel segment must contain only clear liquid. High-quality cleansing results in the ascending colon were a secondary endpoint
- Adequate: Brown liquid or semisolid stools remain but can be cleared easily
Ascending colon:
high-quality cleanse achieved2,4
(NOCT Trial) Colonoscopist/Central Reader*
mITT: P=.059
2-Day Split-Dosing
Patients, %
(Post Hoc) On-Site Colonoscopist†
mITT: P=.079
2-Day Split-Dosing
Patients, %
*Trained central readers assessed the efficacy of bowel cleansing based on video review, using both the HCS and the Boston Bowel Preparation Scale (BBPS)2
†This post hoc analysis shows the cleansing assessment by the site colonoscopists, who typically guide clinical decision-making; hence this analysis may be useful for clinical practice. In the NOCT study, 621 patients (males and females, aged 18–85 years) were randomly assigned in a 1:1 ratio to receive either PLENVU® or Suprep, each administered as an overnight split-dose. Data from the 523 patients who underwent a colonoscopy and had a site colonoscopist assessment were used in this analysis. Colonoscopists were blinded to the preparation administered. Cleansing was assessed according to the HCS; segmental scores 3 and 4 were judged as high-quality cleansing4
mITT, modified intent-to-treat: Used as the primary population for all efficacy analyses and included all randomized patients except for any patient who was randomized but subsequently failed to meet entry criteria or if the same patient did not receive any study drug2
PP, per protocol: Included patients without major protocol deviations, who met eligibility criteria, who took at least 75% of each bowel prep, and who had available data for at least 1 of the primary end points2
References: 1. Plenvu. Prescribing information. Salix Pharmaceuticals, a division of Bausch Health US, LLC; 2023.. 2. DeMicco MP et al. Gastrointest Endosc. 2018;87(3):677-687.e3. doi:10.1016/j.gie.2017.07.047 3. Data on file. Salix Pharmaceuticals. 4. Epstein M et al. Poster presented at: WCOG at ACG 2017; October 13-18, 2017; Orlando, FL. Presentation number P1789.
INDICATION
PLENVU® (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.
IMPORTANT SAFETY INFORMATION
- PLENVU® is contraindicated in patients with gastrointestinal (GI) obstruction, bowel perforation, gastric retention, ileus, toxic megacolon, and hypersensitivity to any of its ingredients.
- Advise patients to hydrate adequately before, during, and after the use of PLENVU®. It is encouraged that patients drink additional clear liquids to help avoid cases of fluid and electrolyte abnormalities. Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures, and renal impairment.
- There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. These occur predominantly in patients with underlying cardiac risk factors and electrolyte disturbances. Consider obtaining ECGs in patients at an increased risk of serious cardiac arrhythmias.
- Use PLENVU® with caution in patients with a history of seizures and those at an increased risk of seizures, including patients taking medications that lower the seizure threshold, patients withdrawing from alcohol or benzodiazepines, or patients with hyponatremia.
- Use PLENVU® with caution in patients with renal impairment or those taking concomitant medications that affect renal function. Advise these patients to adequately hydrate before, during, and after the use of PLENVU® and consider performing laboratory tests in these patients.
- Do not administer PLENVU® to patients with GI obstruction or perforation. If GI obstruction or perforation is suspected, perform appropriate diagnostic studies prior to administering PLENVU®.
- Use caution in patients with severe ulcerative colitis.
- Patients with impaired gag reflex or those prone to regurgitation or aspiration should be observed during the administration of PLENVU®. Use with caution in these patients. Do not combine PLENVU® with starch-based thickeners.
- Use PLENVU® with caution in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- Phenylalanine can be harmful to patients with phenylketonuria (PKU). PLENVU® contains phenylalanine, a component of aspartame. Each PLENVU® treatment contains 491 mg of phenylalanine.
- PLENVU® contains polyethylene glycol and may cause serious hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, and pruritus. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should signs and symptoms occur.
- In clinical trials, the most common adverse reactions (>2% of patients taking PLENVU®) were nausea, vomiting, dehydration, and abdominal pain/discomfort. Adverse reactions were similar between the two dosing regimens.
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.
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INDICATION
PLENVU® (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.
IMPORTANT SAFETY INFORMATION
PLENVU® is contraindicated in patients with gastrointestinal (GI) obstruction, bowel perforation, gastric retention, ileus, toxic megacolon, and hypersensitivity to any of its ingredients.
