PLENVU® has a well-established safety profile1
Common Adverse Events in the NOCT Trial
| Most Common Adverse Events (≥2%) | PLENVU® 2-Day Split-Dosing (n=275) | Suprep® 2-Day Split-Dosing (n=271) |
| Nausea | 7% | 2% |
| Vomiting | 6% | 3% |
| Dehydration* | 4% | 2% |
| Abdominal Pain/Discomfort† | 2% | 2% |
| Decline in Glomerular Filtration Rate (GFR)‡ | 2% | 2% |
| Electrolyte abnormalities§ | 2% | 1% |
| Fatigue | 2% | 1% |
| Headache | 2% | 1% |
*Includes signs and symptoms of dehydration, such as dizziness, dry mouth, orthostatic hypotension, presyncope, syncope, and thirst1
†Includes abdominal discomfort, abdominal pain, lower abdominal pain, upper abdominal pain, and abdominal tenderness1
‡Decreased or abnormal GFR1
§Includes increased anion gap, decreased blood bicarbonate, hypomagnesemia, hyperosmolarity, hypokalemia, hyperkalemia, hypercalcemia, hypernatremia, hyperosmolar state, hyperuricemia, hypocalcemia, and hypophosphatemia1
Demonstrated effective use in special patient populations1,2
Of approximately 1000 patients in clinical trials who received PLENVU®:
experienced no age-related differences in safety and efficacy (21% of the study population)1
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 abnormalities.1
with mild to moderate renal insufficiency achieved a successful cleanse of the overall colon with PLENVU®2,||
Percentage reflective of patients who participated in the NOCT and MORA trials. 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 cleanse2
||Successful Cleansing—Grade A and B. For Grade A, there must be full visibility of the entire bowel mucosa before precleaning. For Grade B, all 5 bowel segments must contain only brown liquid/fully removable semisolid stools, clear liquid, or be empty and clean2
References: 1. Plenvu. Prescribing information. Salix Pharmaceuticals, a division of Bausch Health US, LLC; 2023. 2. Data on file. Salix Pharmaceuticals.
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.
Please click here for full Prescribing Information.
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.
