New FDA-approved colonoscopy prep available

This is a sponsored post. Salix Pharmaceuticals compensated me for this post. All opinions are my own. Certain product information has been included to meet regulations.

I’ll always remember the first time. I was 21 years old. I had just been diagnosed with a lifelong condition, for which there is no known cure—Crohn’s disease. In order to confirm the diagnosis, I was told I would need to undergo a colonoscopy during my hospitalization. The prep and the procedure felt like adding insult to injury. I was already dealing with a horrible flare up while coming to grips with the fact that I had a chronic condition. Having to drink a disgusting concoction, while rocking back in forth in pain on the toilet, still feels like a fresh memory. It was nearly 14 years ago.

IMG_3033My current gastroenterologist is all about the annual colonoscopy. Especially now that I’ve had inflammatory bowel disease (IBD) for over a decade. Let me tell you, those 365 days go fast. No matter how many colonoscopies I’ve had, the prep never gets easier. I vomit every single time. I cry. It’s an emotional experience. It’s a reminder that I’m not like the rest of the 35-year-old population. I shouldn’t be needing this test yet. But I do because I have Crohn’s. The prep leading up to the procedure makes me cringe as I write this…and I don’t even need another colonoscopy until early summer.

I know I’m not alone in my feelings about the prep. According to patients’ experiences and reported barriers to colonoscopy, most patients perceived the bowel preparation to be the most burdensome part of colonoscopy. This is where Salix Pharmaceuticals comes in. They market PLENVU® (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution), a bowel prep cleanse with less active ingredient to drink than some other bowel preps. PLENVU is a 1 liter bowel preparation cleanser available in the United States and in clinical studies, more than 66 percent of patients found the taste to be “acceptable” or “very acceptable”. The PLENVU bowel prep is the only FDA-approved prep for either same-day morning-of-colonoscopy* dosing or 2-day split-dosing.

* The “One-Day Morning Dosing Regimen” (as it is labeled in the Prescribing Information) is referred to as “Same-Day Morning-of-Colonoscopy Dosing.”

INDICATIONS

  • PLENVU® (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride for oral solution) is a prescription medication used by adults to clean the colon before a colonoscopy

IMPORTANT SAFETY INFORMATION

  • Do not take PLENVU® if you have a blockage in your intestine (bowel obstruction), an opening in the wall of your stomach or intestine (bowel perforation), problems with food or fluid emptying from your stomach (gastric retention), a problem with food moving too slowly through your intestines (ileus), a very dilated large intestine, or an allergy to any of the ingredients in PLENVU®.

(See additional Important Safety Information below and click here for full Prescribing Information for PLENVU®.)

Colonoscopies aren’t something that only IBD patients need to worry about. For people at average risk for colorectal cancer, the American Cancer Society recommends a regular screening for adults starting at age 45. According to the CDC, colorectal cancer is the second leading cause of cancer-related deaths in men and women in the U.S. Additionally, American Cancer Society estimates there will be 101,420 new cases of colon cancer and 44,180 cases of rectal cancer in 2019. And because it’s National Colorectal Cancer Awareness Month, if you’re 45 or older, I encourage you to be proactive and vigilant about your health and schedule your colonoscopy today. By getting a routine colonoscopy, you can increase your chances of nipping the disease in the bud, before it’s too late.

Click here to learn more about PLENVU and talk with your doctor and inquire about this new prep. I’ve already done so with my GI. I plan to try PLENVU during my colonoscopy this summer.

PLENVU’s Indications and Important Safety Information:

INDICATION

PLENVU® (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride for oral solution) is a prescription medication used by adults to clean the colon before a colonoscopy.

IMPORTANT SAFETY INFORMATION

  • Do not take PLENVU® if you have a blockage in your intestine (bowel obstruction), an opening in the wall of your stomach or intestine (bowel perforation), problems with food or fluid emptying from your stomach (gastric retention), a problem with food moving too slowly through your intestines (ileus), a very dilated large intestine, or an allergy to any of the ingredients in PLENVU®.
  • It is important to drink sufficient clear liquids before, during, and after the use of PLENVU®. Be sure to consume additional clear liquids after the first dose and second dose of PLENVU®. Stop drinking liquids 2 hours prior to colonoscopy.
  • Before you take PLENVU®, talk to your doctor if you:
    • Have problems with serious loss of body fluid (dehydration) and changes in blood salts (electrolytes).
    • Have heart problems or take medication that affects your heart. Your doctor may consider obtaining an electrocardiogram (ECG) test if you are at an increased risk for heart rhythm abnormalities.
    • Have a history of seizures or take antiseizure medication.
    • Have kidney problems or take medication that affects kidney function. Your doctor may want to perform blood testing before and after your colonoscopy.
    • Have a history of stomach or bowel problems, such as ulcerative colitis, a bowel blockage, or a suspected opening in the wall of your stomach or intestine.
    • Have problems swallowing, heartburn (gastric reflux), or if you inhale food or fluid into your lungs when eating or drinking (aspirate).
    • Have a condition that destroys red blood cells, called glucose-6-phosphate dehydrogenase (G6PD) deficiency.
    • Are withdrawing from drinking alcohol.
    • Have phenylketonuria (PKU). PLENVU® contains aspartame equivalent to 491 mg of phenylalanine per treatment.
    • Are pregnant or plan to become pregnant.
    • Are breastfeeding or plan to breastfeed.
  • PLENVU® may affect how other medications work. Tell your doctor about all other medications (including prescription and nonprescription medicines, vitamins, and herbal supplements) you take before you take PLENVU®. Do not take oral medications within 1 hour before or after starting each dose of PLENVU®.
  • Symptoms of serious allergic reactions may include skin rash, itching, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat, and kidney problems.
  • In clinical studies with PLENVU®, the most common side effects in patients taking PLENVU® were nausea, vomiting, dehydration, and abdominal pain/discomfort.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click here for full Prescribing Information for PLENVU®.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center

Phone: 1-800-321-4576

Fax: 1-510-595-8183

Email: salixmc@dlss.com

 

 

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s