Plenvu

What is Plenvu?

Plenvu is a prescription medicine used by adults to clean the colon before a colonoscopy. 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.

It is not known if Plenvu is safe and effective in children.

Description

The active ingredients contained in PLENVU are provided in Table 3.

Table 3: Details of Active Ingredients contained in PLENVU

Chemical Name	Chemical Formula	Average Molecular Weight (g/mol)	Chemical Structure
Polyethylene Glycol (PEG) 3350	H-(OCH2-CH2)n-OH	3350
Sodium Ascorbate	C6H7NaO6	198.1
Sodium Sulfate	Na2SO4	142.0
Ascorbic Acid	C6H8O6	176.1
Sodium Chloride	NaCl	58.4	Na+ Cl–
Potassium Chloride	KCl	74.6	K+ Cl+

PLENVU (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) is an osmotic laxative consisting of three pouches (one for Dose 1, one for Dose 2 Pouch A and one for Dose 2 Pouch B) containing white to yellow powder for reconstitution.

Dose 1 contains 100 grams of PEG 3350, 9 grams of sodium sulfate, 2 grams of sodium chloride, and 1 gram of potassium chloride, and the following excipients: sucralose, encapsulated citric acid and mango flavoring. When Dose 1 is dissolved in water to a volume of 16 fluid ounces, PLENVU Dose 1 (PEG 3350, sodium sulfate, sodium chloride and potassium chloride) is an oral solution having a mango flavor.

Each Dose 2 Pouch A contains 40 grams of PEG 3350, 3.2 grams of sodium chloride, and 1.2 grams of potassium chloride, and the following excipients: aspartame and fruit punch flavoring.

Each Dose 2 Pouch B contains 48.11 grams of sodium ascorbate and 7.54 grams of ascorbic acid.

When Dose 2 Pouch A and Dose 2 Pouch B are dissolved together in water to a volume of 16 fluid ounces, PLENVU Dose 2 (sodium ascorbate, PEG 3350, ascorbic acid, sodium chloride and potassium chloride) is an oral solution having a fruit punch flavor.

The entire, reconstituted, 32 fluid ounces of PLENVU bowel preparation contains 140 grams of PEG 3350, 48.11 grams of sodium ascorbate, 9 grams of sodium sulfate, 7.54 grams of ascorbic acid, 5.2 grams of sodium chloride and 2.2 grams of potassium chloride and the following excipients: aspartame, sucralose, encapsulated citric acid, mango and fruit punch flavorings.

A mixing container for reconstitution is enclosed.

Phenylketonurics: Contains Phenylalanine 491 mg per treatment.

Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).

Mechanism of Action

The primary mode of action is osmotic action of the components of PLENVU (PEG 3350 plus sodium sulfate components in Dose 1, and sodium ascorbate and ascorbic acid plus PEG 3350 components in Dose 2) which induce the laxative effect. The physiological consequence is increased water retention in the lumen of the colon, resulting in loose stools.

What is the most important information I should know about Plenvu?

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).
• vomiting
• urinating less often than normal
• dizziness
• headache

Tell your healthcare provider right away if you have any of these symptoms of serious loss of body fluid (dehydration) while taking Plenvu:

See “What are the possible side effects of Plenvu?” for more information about side effects.

Who should not take Plenvu?

Do not take Plenvu if your healthcare provider has told you that you have:

• a blockage in your intestine (bowel obstruction).
• an opening in the wall of your stomach or intestine (bowel perforation).
• problems with food and fluid emptying from your stomach (gastric retention).
• a problem with food moving too slowly through your intestines (ileus).
• a very dilated intestine (toxic megacolon).
• an allergy to any of the ingredients in Plenvu. See the end of this leaflet for a complete list of ingredients in Plenvu.

What should I tell my healthcare provider before taking Plenvu?

Before taking Plenvu, tell your healthcare provider about all of your medical conditions, including if you:

• 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.
• are withdrawing from drinking alcohol.
• have phenylketonuria (PKU). Plenvu contains phenylalanine.
• are allergic to any of the ingredients in Plenvu.
• are pregnant or plan to become pregnant. It is not known if Plenvu will harm your unborn baby. Talk to your healthcare provider if you are pregnant.
• are breastfeeding or plan to breastfeed. It is not known if Plenvu passes into your breast milk. You and your healthcare provider should decide if you will take Plenvu while breastfeeding.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

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

Especially tell your healthcare provider if you take:

• medicines to treat a blood salt (electrolyte) imbalance.
• medicines for blood pressure or heart problems.
• medicines for seizures (antiepileptics).
• medicines for kidney 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.

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking any of the medicines listed above.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Plenvu?

See the Instructions for use that come with Plenvu for dosing instructions. You must read, understand, and follow these instructions to take Plenvu the right way.

• Take Plenvu exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you to take the Two-Day Split-Dosing option or the One-Day Morning Dosing option.
• Drink 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.
• Do not eat solid food while taking Plenvu until after your colonoscopy.
• It is important for you to drink the additional amount of clear liquids listed in the Instructions for Use.
• You may have stomach-area (abdomen) bloating after your first dose of Plenvu.
  • If you have severe stomach-area (abdomen) discomfort or bloating, stop drinking Plenvu for a short time or wait a longer time between each dose of Plenvu until your stomach-area symptoms improve. If your stomach-area discomfort or bloating continues, tell your healthcare provider.
• Your first bowel movement may happen about 1 to 2 hours after you start taking Plenvu.
• If you take too much Plenvu, call your healthcare provider.

What are the possible side effects of Plenvu?

Plenvu can cause serious side effects including:

• Changes in certain blood tests. Your healthcare provider may do blood tests after you take Plenvu to check your blood for changes. Tell your healthcare provider if you have any symptoms of too much fluid loss, including:
  • vomiting
  • heart problems
  • seizures
  • dizziness
  • Kidney problems
  • dry mouth
  • feel faint, weak or lightheaded especially when you stand up (orthostatic hypotension)
• Ulcers of the bowel or bowel problems (ischemic colitis):Tell your healthcare provider right away if you have severe stomach-area (abdomen) pain or rectal bleeding.
• Serious allergic reactions. Symptoms of a serious allergic reaction may include:
  • Skin rash
  • Raised red patched
  • Kidney problems
  • itching
  • swelling of the face, lips, tongue and throat

The most common side effects of Plenvu include:

• nausea
• vomiting
• dehydration
• stomach pain or discomfort

These are not all the possible side effects of Plenvu.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Plenvu

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Plenvu for a condition for which it was not prescribed. Do not give Plenvu to other people, even if they are going to have the same procedure you are. It may harm them.
You can ask your pharmacist or healthcare provider for information that is written for healthcare professionals.

How should I store Plenvu?

• Store Plenvu (before opening and after mixed) at room temperature, between 68°F to 77°F (20°C to 25°C). Plenvu may also be stored in a refrigerator.
• Use Plenvu within 6 hours after mixing with water.

Keep Plenvu and all medicines out of the reach of children.

What are the ingredients in Plenvu?

Active ingredient:

Dose 1: PEG 3350, sodium sulfate, sodium chloride, potassium chloride
Dose 2 Pouch A: PEG 3350, sodium chloride, potassium chloride
Dose 2 Pouch B: sodium ascorbate, ascorbic acid

Inactive ingredients:
Dose 1: sucralose, encapsulated citric acid, mango flavoring
Dose 2 Pouch A: aspartame, fruit punch flavoring

Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – PLENVU OUTER CARTON

• Rx only
  NDC 65649-400-01
  PLENVU®
• (polyethylene glycol 3350, sodium ascorbate,
  sodium sulfate, ascorbic acid, sodium chloride
  and potassium chloride for oral solution)
  140 g, 48.11 g, 9 g, 7.54 g, 5.2 g, 2.2 g
• This carton contains:

SRC: NLM .