Plenvu: Uses, Side Effects and Dosage

What is PLENVU used for?

• To clean the colon before a colonoscopy in adults.

How does PLENVU work?

PLENVU cleans your colon by causing you to have diarrhea (loose stools). Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy. Your first bowel movement may happen about 1 to 2 hours after you start taking PLENVU.

What are the ingredients in PLENVU?

Medicinal ingredients:

• Dose 1: PEG 3350 (100 g), Sodium Sulfate Anhydrous (9 g), Sodium Chloride (2 g), Potassium Chloride (1 g).
• Dose 2 Pouch A: PEG 3350 (40 g), Sodium Chloride (3.2 g), Potassium Chloride (1.2 g).
• Dose 2 Pouch B: Sodium Ascorbate (48.11 g), Ascorbic Acid (7.54 g).

Non-medicinal ingredients:

• Dose 1: encapsulated Citric Acid, Mango Flavoring, Sucralose.
• Dose 2 Pouch A: Aspartame, Fruit Punch Flavoring.

PLENVU comes in the following dosage forms:

PLENVU consists of 3 pouches (one for Dose 1, one for Dose 2 Pouch A and one for Dose 2 Pouch B) containing white to yellow powder for oral solution.

Do not use PLENVU if:

• you have an allergy to any of the ingredients in PLENVU listed above.
• you have a blockage in your intestine (bowel obstruction).
• you have an opening in the wall of your stomach or intestine (bowel perforation).
• you have problems with food and fluid emptying from your stomach (gastric retention / gastroparesis).
• you have a problem with food moving too slowly through your intestines (ileus).
• you have problems related to inflammation in your colon (toxic megacolon / toxic colitis).
• you have a serious condition in your abdomen that requires surgery (such as appendicitis or diverticulitis).
• you are unconscious.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take PLENVU. Talk about any health conditions or problems you may have, including if you:

• have stomach pain, nausea or vomiting.
• have problems with serious loss of body fluid (dehydration) and changes in blood salts (electrolytes).
• have heart problems.
• have seizures or take medicines for seizures.
• have kidney problems or take medicines for kidney problems.
• have stomach or bowel problems, including ulcerative colitis.
• have problems with swallowing, gastric reflux or if you inhale food or fluid into your lungs when eating or drinking (aspirate).
• have a condition called glucose-6-phosphate dehydrogenase (G6PD) deficiency that destroys red blood cells.
• have phenylketonuria (PKU). PLENVU contains Aspartame, a source of Phenylalanine – up to 491 mg per treatment.
• are withdrawing from drinking alcohol or benzodiazepines.

• are pregnant or plan to become pregnant. It is not known if PLENVU will harm your unborn baby. PLENVU should only be used during pregnancy if your healthcare professional considers it essential.

• are breastfeeding or plan to breastfeed. It is not known if PLENVU passes into your breast milk.

Other warnings you should know about:

PLENVU and other bowel preparations can cause serious side effects, including:

• Serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. These changes can cause:

  • abnormal heartbeats that can cause death.
  • seizures. This can happen even if you have never had a seizure.
  • kidney problems.

Your chance of having fluid loss and changes in body salts with PLENVU is higher if you:

• have heart problems.
• have kidney problems.
• take water pills (diuretics), high blood pressure medicine or non-steroidal anti-inflammatory drugs (NSAIDs).

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.

PLENVU may affect how other medicines work. Do not take medicines by mouth 1 hour before or after the start of PLENVU.

The following may interact with PLENVU:

• Medicines to treat a blood salt (electrolyte) imbalance.
• Medicines for blood pressure or heart problems.
• Water pills (diuretics).
• Non-steroidal anti-inflammatory drugs (NSAIDs).
• Laxatives. Do not take other laxatives while taking PLENVU.
• Medicines for depression or other mental health problems.
• Starch based food thickeners. If you have swallowing difficulty, avoid starch-based food thickeners while taking PLENVU.

How to take PLENVU:

• You must read, understand, and follow the instructions given below to take PLENVU.
• There are two different options for taking PLENVU. Your healthcare provider will tell you to take the Two-Day Split-Dosing option or the One-Day Morning Dosing option.
• You must drink all of Dose 1 (one pouch) and Dose 2 (two pouches) of PLENVU for either
• dosing option. Make sure you finish Dose 2 at least 2 hours before your colonoscopy. Do not add any other ingredients to PLENVU.
• PLENVU must be mixed with water.

• It is important to drink additional clear liquids before, during, and after you take PLENVU, up until 2 hours before your colonoscopy, to help prevent fluid loss (dehydration), and changes in blood salt (electrolyte) levels.

Examples of clear liquids are:

• water
• clear broth soups
• herbal tea, black tea or coffee
• watered down (diluted) (from concentrate) clear fruit juices (without pulp) including apple juice or white grape juice
• clear soda
• gelatin (without added fruit or topping)
• popsicles (without pieces of fruit or fruit pulp)
• strained limeade or lemonade
• Do not eat solid food while taking PLENVU until after your colonoscopy.
• Do not drink alcohol, milk, anything colored red or purple or any foods that have pulp.
• If you feel like you have severe stomach pain or discomfort you can stop taking PLENVU for a short time until the discomfort stops and then continue taking it. You can take smaller sips of PLENVU so that you space out your dose longer than 30 minutes. If you continue to have severe stomach pain, call your healthcare provider.

Preparing PLENVU

The following are provided in each carton box:

Dose 1: Empty Dose 1 into a suitable container (or provided measuring up). Add up to 500 mL of water and mix everything together with a spoon, until completely dissolved. This can take up to 2 to 3 minutes.

Dose 2: Empty Dose 2 Pouch A and Dose 2 Pouch B into a suitable container (or provided measuring up). Add up to 500 mL of water and mix everything together with a spoon, until completely dissolved. This can take up to 2 to 3 minutes.

Two-Day Split-Dosing Schedule

On the day before the colonoscopy, you can eat a light breakfast followed by a light lunch.

You must finish eating lunch at least 3 hours before you start taking PLENVU.

Take Dose 1 in the evening sometime between 4 pm and 8 pm. Drink the whole dose over 30 minutes. Refill the container with 500mL of clear liquids and drink over the next 30 minutes. For a list of clear liquids, see examples provided above in “How to take PLENVU”.

Continue to drink additional clear liquids during the evening, this is important to help avoid dehydration. After taking PLENVU if you have any bloating or feeling like your stomach is upset, wait to take Dose 2 until your stomach feels better.

Take Dose 2 the next morning, on the day of the colonoscopy. This should be about 12 hours (between about 4 am and 8 am) after you started Dose 1. Make sure you finish Dose 2 at least 2 hours before your colonoscopy. Drink the whole dose over 30 minutes. Refill the container with 500mL of clear liquids and drink over the next 30 minutes.

One-Day Morning Dosing Schedule

On the day before the colonoscopy, you can eat a light breakfast followed by a light lunch. For dinner you may have clear broth soup and/or plain yogurt. You should finish dinner by about 8 pm.

Take Dose 1 the morning of your colonoscopy sometime between 3 am and 7 am. Drink the whole dose over 30 minutes. Refill the container with 500mL of clear liquids and drink over the next 30 minutes. For a list of clear liquids, see examples provided above in “How to take PLENVU”. Continue to drink additional clear liquids up until 2 hours before your procedure. This is important to help avoid dehydration. After taking PLENVU if you have any bloating or feeling like your stomach is upset, wait to take Dose 2 until your stomach feels better.

Take Dose 2 at least two hours after you start Dose 1. Make sure you finish Dose 2 at least 2 hours before your colonoscopy. Drink the whole dose over 30 minutes. Refill the container with 500mL of clear liquids and drink over the next 30 minutes.

Usual dose:

Two doses of PLENVU are required for a complete preparation for colonoscopy. Your healthcare provider will tell you to use the Two-Day Split-Dosing or One-Day Morning Dosing Regimen.

Overdose:

If you use more PLENVU than you should, this could lead to:

• severe changes in blood salts (electrolytes). This may cause heart problems (cardiac arrhythmias), seizures or kidney failure.
• serious loss of body fluid (dehydration).
• decreased volume of blood in the body (hypovolemia).

Missed Dose:

If you miss your dose, PLENVU should be taken as soon as possible. If several hours have passed since the time when the dose should have been taken talk to your healthcare professional. It is important that the preparation be completed at least two hours before the procedure.

What are possible side effects from using PLENVU?

These are not all the possible side effects you may have when taking PLENVU. If you experience any side effects not listed here, tell your healthcare professional.

The most common side effects of PLENVU include nausea, vomiting, and stomach pain or discomfort.

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

Storage:

• Store PLENVU package (before opening and after mixed) between 5-30°C.
• After reconstitution with water, keep PLENVU solution between 5-25°C for up to 24 hours.
• Keep out of reach and sight of children.

If you want more information about PLENVU:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.bauschhealth.ca; or by calling 1-800-361-4261.

Last Revised: AUG 16, 2024