PLENVU® (PEG 3350, Sodium Ascorbate, Sodium Sulfate, Ascorbic Acid, Sodium Chloride, and Potassium Chloride).
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PLENVU provided patients with a positive bowel prep experience1,*

Acceptability of taste1,2,†,‡
PLENVU acceptability of taste
as many patients rated the taste of PLENVU
“very acceptable” vs patients who took Suprep

Willingness to take again2,†
78 percent willingness to take PLENVU again
of patients were willing to take PLENVU again vs 72% of those who took Suprep (P=.1435)

Other parameters tested1:

  • Very or quite easy to follow instructions for preparation (88%, PLENVU vs 89%, Suprep; P=.7911)
  • Very or quite easy to drink (56%, PLENVU vs 52%, Suprep; P=.3504)
  • Think cleaned bowel very well or quite well (87%, PLENVU vs 90%, Suprep; P=.4266)
  • Did not interfere at all or interfered a little in normal daily activities (65%, PLENVU vs 59%, Suprep; P=.1903)
* Based on patient diary ratings related to acceptability of taste and willingness to take again.2
Based on a post hoc analysis.2
Very acceptable: 15.2%, PLENVU vs 7.5%, Suprep; very acceptable or acceptable: 66.7%, PLENVU vs 50.7%, Suprep (P=.0001).

PLENVU was well tolerated2,3

Only 0.1% of patients discontinued due to side effects2
Side effects is less than 2 percent in NOCT and MORA

PLENVU can be used effectively in special patient populations

  • As many as 96% of patients with mild to moderate renal insufficiency achieved a successful colon cleanse with PLENVU2,‡,§
  • No age-related differences in safety and efficacy were observed in patients over 65 years of age (21% of the study population)3
    • However, elderly patients are more likely to have decreased hepatic, renal, or cardiac function and may be more susceptible to adverse reactions resulting from fluid and electrolyte abnormalities3
* The "One-Day Morning Dosing Regimen" (as it is labeled in the Prescribing Information) is referred to as "Same-Day Morning-of-Colonoscopy Dosing."
Includes signs and symptoms of dehydration, such as dizziness, dry mouth, orthostatic hypotension, presyncope, syncope, and thirst.3
Mild renal insufficiency was defined as a creatinine clearance (CrCl) ≥60 mL/min to <90 mL/min. Moderate renal insufficiency was defined as CrCl ≥30 mL/min to <60 mL/min.2
§ In the NOCT trial, of patients with mild renal impairment, 89% taking PLENVU achieved a successful cleanse; in the MORA trial, of patients with mild to moderate renal impairment, 96% taking PLENVU in the 2-day arm and 91% taking PLENVU in the 1-day arm achieved a successful cleanse.2

References: 1. 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. 2. Data on file. Salix Pharmaceuticals. 3. Plenvu [package insert]. Hengoed, UK: Norgine Ltd; 2018.

 
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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.