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This Medical Industry Feature titled “Examining a Bowel Prep in Practice: A Gastroenterologist’s Experience", is sponsored by Salix Pharmaceuticals.
Please stay tuned for important safety information throughout of this episode and see full prescribing information at plenvuhcp.com.
All of Dr. David Poppers comments are based on his personal clinical experience and expert opinion. Dr David Poppers received payment from Salix Pharmaceuticals for his testimony.
Dr. Poppers:
Hello, my name is Doctor David Poppers. I am Director of GI Quality and Strategic Initiatives for the Center for Women’s Health and the Center for Men’s Health at NYU Langone Health. I’m also a Clinical Professor in the Department of Medicine at the NYU Grossman School of Medicine.
When it comes to patients having a successful colonoscopy, bowel cleansing efficacy is paramount. I frequently emphasize to my patients that bowel preparation is homework― not for class time. If they don’t properly prepare for their colonoscopy, they might not have a successful procedure. However, finding a bowel preparation that’s right for some patients can be a challenge. It’s important that a patient is willing and able to take their bowel preparation.
Announcer:
Why do you prescribe PLENVU for your patients?
Dr. Poppers:
PLENVU® has been a game changer for me. During procedures, PLENVU® has definitely helped me to see certain lesions and polyps I might have otherwise missed. This provides reassurance to me as well as my patients that they are getting the most out of their colonoscopies. I’ve used PLENVU® for essentially all of my patients and I’ve been very happy with the results.
Announcer:
INDICATION
PLENVU® 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.
Please stay tuned for important safety information throughout of this episode and see full prescribing information at plenvuhcp.com.
What do patients say about their experience with PLENVU®?
Dr. Poppers:
I use PLENVU® not only for its efficacy, but also because patient feedback about PLENVU® has been positive. When considering patient tolerability, it’s important to note the results from the NOCT Trial, which was a randomized, multicenter, colonoscopist/central reader-blinded, phase 3, noninferiority study which assessed the bowel cleansing, efficacy, safety, and tolerability of PLENVU® compared with Suprep® in 556 adults in a 2 dose split-dosing regimen using the validated Harefield Cleansing Scale.
In a post hoc analysis from this trial, the patient diary ratings related to acceptability of taste showed that twice as many patients rated the taste of PLENVU® to be very acceptable compared with patients who took Suprep. Additionally, 66.7% of patients rated PLENVU® very acceptable or acceptable compared with 50.7% of Suprep patients. What I have heard from my patients is reflective of these results, which gives us that much more confidence to continue prescribing PLENVU® in the future.
Announcer:
Does PLENVU® offer additional support for patients?
Dr. Poppers:
The educational resources PLENVU® provides have been essential. Having tools such as dosing instruction sheets has been really helpful in ensuring patients are taking PLENVU® properly. I also appreciate that PLENVU® has a savings program to make their product more accessible for eligible commercially insured and Medicare Part D patients.
Announcer:
IMPORTANT SAFETY INFORMATION
• 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.
Please stay tuned for important safety information throughout of this episode and see full prescribing information at plenvuhcp.com.
What would you tell other HCPs about implementing PLENVU® for their practice?
Dr. Poppers:
Now is a good time to consider PLENVU® for your patients. As soon as I implemented PLENVU® in our practice, I was quick to educate my patients and staff about the product’s tolerability and efficacy, which can help lead to successful bowel preparation. From a physician’s perspective, since implementing PLENVU®, my staff and I have seen efficiencies throughout the preparation process, providing a streamlined approach to colonoscopies. Other healthcare providers I have spoken with about using PLENVU® have seen similar results. Consider implementing PLENVU® in your office protocol as a standard bowel preparation for your appropriate patients.
Announcer:
Talk to your patients about PLENVU® today.
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.
Announcer:
Please see full prescribing information at plenvuhcp.com.
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