Why PLENVU®?
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When your patients prep for a colonoscopy
All it takes is Little PEG

PLENVU: the first and only 1-L PEG bowel prep with a powerful cleanse comparable to Suprep®1-3

Successful cleansing
in the overall colon1-3,*,†

PLENVU overall colon efficacy vs Suprep

High-quality cleansing in the
ascending colon4,*,†

PLENVU efficacy of the ascending colon vs Suprep

Most common side effects

The most common side effects (>2%) in the NOCT trial were1:

  • PLENVU: nausea, vomiting, and dehydration
  • Suprep: vomiting

PLENVU delivered successful cleansing comparable to MoviPrep®, with 50% less active solution1,3

Successful cleansing
in the overall colon1,3,*,‡

PLENVU efficacy in the overall colon vs Moviprep
Peggie cleaning with a mop

Most common side effects

The most common side effects (>2%) in the MORA trial were1:

  • PLENVU: vomiting, nausea, dehydration, and abdominal pain/discomfort
  • MoviPrep: nausea and abdominal pain/discomfort
Peggie cleaning with a mop.

Successful cleansing
in the ascending colon3,*,‡

PLENVU efficacy in the ascending colon vs Moviprep
  • PLENVU achieved superior cleansing of the ascending colon vs MoviPrep (HCS rating of good or excellent)3

Most common side effects

The most common side effects (>2%) in the MORA trial were1:

  • PLENVU: vomiting, nausea, dehydration, and abdominal pain/discomfort
  • MoviPrep: nausea and abdominal pain/discomfort
Peggie cleaning with a mop.
Patients had a positive experience with PLENVU. Learn more Go To - Arrow Symbol See available dosing options Go To - Arrow Symbol
mITT, modified intent-to-treat; PP, per protocol.
* The Harefield Cleansing Scale (HCS) criteria are applied after precleaning of the colon. A successful cleansing is defined as a grade A or B. To receive a grade of A, there must be full visibility of the entire bowel mucosa before precleaning. To receive a grade of B, all 5 bowel segments must contain only brown liquid/fully removable semisolid stools, clear liquid, or be empty and clean. A high-quality cleansing is defined as “excellent” or “good.” To receive an “excellent” rating, the bowel segment must be empty and clean. To receive an HCS rating of “good,” the bowel segment must contain only clear liquid. An “adequate” rating means the bowel segment has brown liquid/removable semisolid stools.3
The NOCT trial was a multicenter, randomized, parallel-group, phase 3 study comparing the bowel-cleansing efficacy, safety, and tolerability of PLENVU vs Suprep using a 2-day split-dosing regimen in adults. The mITT was used as the primary population for all efficacy analyses and included all randomized patients with the exception of any patient who was randomized but subsequently failed to meet entry criteria or if the same patient did not receive any study drug. The PP set 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 one of the primary end points.1,2
The MORA trial was a multicenter, randomized, parallel-group, phase 3 study comparing the bowel-cleansing efficacy, safety, and tolerability of the PLENVU same-day morning-of-colonoscopy and 2-day split-dosing regimens vs the MoviPrep 2-day split-dosing regimen in adults.1
§ The “One-Day Morning Dosing Regimen” (as it is labeled in the Prescribing Information) is referred to as “Same-Day Morning-of-Colonoscopy Dosing.”

References: 1. Plenvu [package insert]. Hengoed, UK: Norgine Ltd; 2018. 2. DeMicco MP, Clayton LB, Pilot J, Epstein MS; NOCT Study Group. Novel 1 L polyethylene glycol-based bowel preparation NER1006 for overall and right-sided cleansing of the colon: a randomized controlled phase 3 trial versus trisulfate. Gastrointest Endosc. 2018;87(3):677-687.e3. 3. Data on file. Salix Pharmaceuticals. 4. Epstein M, Shing RN, Bekal P. Bowel preparation quality of NER1006 versus oral trisulfate solution as assessed by colonoscopists at site: a post hoc analysis from a randomized controlled trial [ACG 2017 abstract 175]. Am J Gastroenterol. 2017;112(suppl 1):S45-S104.

 
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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.
  • 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 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.

Please click here for full Prescribing Information.