Plenvu

Plenvu is a prescription medication used to empty the large intestines in adults before a colonoscopy, a procedure used to look inside the large intestines using a camera-equipped tube.

Plenvu belongs to a group of drugs called osmotic laxatives. This group of drugs empty the intestines by drawing water into the intestines to soften the contents and increase intestinal movement.

This medication comes in powder form that needs to be mixed with water and needs to be taken in two separate doses either in one day or two days depending on the dosing regimen. It should be taken without food.

Common side effects of Plenvu include nausea, vomiting, water loss, and stomach pain/discomfort. Do not drive or operate heavy machinery until you know how Plenvu affects you.

Plenvu is a prescription medication used to empty the large intestines before a colonoscopy.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Plenvu. See the “Plenvu Precautions” section.

Common side effects of Plenvu include the following:

• nausea
• vomiting
• water loss
• stomach pain/discomfort
• headache

This is not a complete list of Plenvu side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• laxatives used to stimulate intestinal muscle movement such as
  • bisacodyl (Dulcolax)
  • sodium picosulfate (Picolax)
  • sodium docusate (Colace)
  • senna (Senokot)
  • oxyphenisatin (Veripaque)
• diuretics such as
  • acetazolamide (Diamox)
  • amiloride (Midamor)
  • bumetanide (Bumex)
  • chlorothiazide (Diuril)
  • chlorthalidone (Thalitone)
  • ethacrynic acid (Edecrin)
  • furosemide (Lasix)
  • hydrochlorothiazide (Microzide, HCTZ)
  • metolazone (Zaroxolyn)
  • torsemide (Demadex)
  • triamterene (Dyrenium, Dyazide, Maxzide)
• angiotensin-converting enzyme (ACE) blockers such as
  • benazepril (Lotensin, Lotensin HCT)
  • captopril (Capoten, Capozide)
  • enalapril (Vasotec, Vaseretic)
  • fosinopril (Monopril, Monopril HCT)
  • lisinopril (Prinivil, Prinzide, Zestril, Zestoretic)
  • moexipril (Univasc, Uniretic)
  • quinapril (Accupril, Accuretic, Quinaretic)
  • ramipril (Altace)
  • trandolapril (Mavik, Tarka)
• angiotensin receptor II blockers such as
  • azilsartan (Edarbi)
  • candesartan (Atacand)
  • irbesartan (Avapro)
  • losartan (Cozaar)
  • olmesartan (Benicar)
  • telmisartan (Micardis, Twynsta)
  • valsartan (Diovan)
• aspirin and other NSAIDs (nonsteroidal anti-inflammatory drugs) such as
  • celecoxib (Celebrex)
  • diclofenac (Cambia, Cataflam, Flector, Voltaren, Zipsor and others)
  • etodolac (Lodine)
  • ibuprofen (Advil, Motrin, Nuprin)
  • indomethacin (Indocin, Indocin SR)
  • ketoprofen (Orudis, Actron, Oruvail)
  • ketorolac (Toradol)
  • meloxicam (Mobic)
  • nabumetone (Relafen)
  • naproxen (Naprosyn)
  • naproxen sodium (Aleve, Anaprox, Naprelan)
  • oxaprozin (Daypro)
  • piroxicam (Feldene)
• tricyclic antidepressants such as
  • trimipramine (Surmontil)
  • amitriptyline (Elavil)
  • nortriptyline (Pamelor, Aventyl)
  • protriptyline (Vivactil)
  • clomipramine (Anafranil)
• Alcohol and benzodiazepine medications such as
  • clonazepam (Klonopin)
  • diazepam (Diastat)
  • lorazepam (Ativan)
  • midazolam (Versed)
  • alprazolam (Xanax)
  • temazepam (Restoril)

This is not a complete list of Plenvu drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Plenvu including the following:

• Serious fluid and salt abnormalities. Patients may experience disturbances in fluid and salt levels. Tell your doctor or get medical help right away if you get any of these symptoms at anytime during your treatment:
  • vomiting
  • water loss (dry skin, more yellowish urine, dry mouth, increased thirst)
  • hallucinations (seeing or hearing things that are not real)
  • fainting
  • seizures
  • coma.
  • headache
  • difficulty concentrating
  • memory changes
  • confusion
  • weakness/tiredness and unsteadiness on your feet
• Irregular heartbeats. Patients with risk factors for heart problems and salt imbalance are more likely to experience serious irregular heartbeat problems. Tell your doctor or get medical help right away if you get any of these symptoms at anytime during your treatment:
  • feeling faint
  • lightheadedness
  • dizziness
  • feeling like your heart is beating irregularly or quickly
• Seizures. Even patients with no prior history of seizures experienced seizures due to salt imbalance. Tell your doctor or get medical help right away if you get any of these symptoms at anytime during your treatment:
  • loss of consciousness
  • violent muscle contraction
• A decline in kidney function. Toxicity from Plenvu may occur with kidney dysfunction. Your doctor may want to monitor your kidney functions with certain blood tests as well. Tell your healthcare provider right away if you have any of the following symptoms of kidney dysfunction:
  • swelling of face, ankles, hands, or feet
  • fatigue
  • paleness of skin
  • decreased urination
  • shortness of breath
  • change in blood pressures
• Inflammation or injury of the large intestine. Serious inflammation and injury may occur from Plenvu. Tell your healthcare provider right away if you have any of the following symptoms:
  • stomach pain
  • blood in stool
  • fever
• Digestive tract disease. Blockage and holes in the digestive tract need to be ruled out before treatment with Plenvu.
• hypersensitivity (severe allergic reaction). Tell your healthcare provider about any signs or symptoms of hypersensitivity, which include the following:
  • chest pain
  • swelling of the face, eyes, lips, tongue, arms, or legs
  • difficulty breathing or swallowing
  • Rash
• Aspiration. Patients who have difficulty swallowing may throw up or breathe Plenvu into the airways.
• Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency. Patients with this condition may experience red blood cell breakdown when exposed to Plenvu. Tell your healthcare provider right away if you have any of the following symptoms:
  • feeling weak, tired, or you get tired easily
  • you look pale
  • you feel short of breath
• Phenylketonuria. Each Plenvu treatment contains 491 mg of phenylalanine. If you have a medical condition that cannot process phenylalanine, take this into account when determining your daily intake of phenylalanine.

No known food interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Plenvu, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Plenvu, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Plenvu or to any of its ingredients
• have problems with serious loss of water and changes in blood salt levels
• have heart problems
• have seizures
• have kidney problems
• have stomach or intestinal problems
• have problems with swallowing, stomach acid reflux, or inhale food/drink into your lungs when eating/drinking
• have a hereditary condition that destroys red blood cells called glucose-6-phosphate dehydrogenase (G6PD)
• cannot process phenylalanine due to a condition called phenylketonuria (PKU)
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements such as

• medicines to treat blood salt imbalance
• medicines for blood pressure or heart problems
• medicines for seizures
• medicines for kidney problems
• water pills
• non-steroidal anti-inflammatory drugs
• medicine used to empty the intestines
• medicine for depression and other mental health problems

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-done studies that have been done in humans with Plenvu. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Plenvu crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Plenvu.

Take Plenvu exactly as prescribed.

This medication comes in a powder form that needs to be mixed with water and needs to be taken in two separate doses either in one day or two days depending on the dosing regimen.

Plenvu can decrease the absorption of drugs when taken together. Take oral medications at least one hour before taking Plenvu.

It should be taken without food. No solid food should be consumed when starting Plenvu until the end of the colonoscopy.

Additional clear fluids including water must be taken after taking Plenvu. Nothing should be taken two hours prior to the colonoscopy.

One-day dosing regimen

A light breakfast and light lunch may be consumed. Dinner consiting of clear broth soup and plain yogurt should be completed by 8 pm. In case of severe bloating or stomach pain, each dose of Plenvu can be taken over longer intervals or should be temporarily stopped until they go away.

Dose 1 - On the day of colonoscopy, between 3 am and 7 am:

1. Thoroughly mix Dose 1 with at least 16 oz of water in the mixing container.
2. Drink all of the solution over the next 30 minutes.
3. Refill the container with at least 16 oz of clear liquid and drink over the next 30 minutes.

Dose 2 - On the day of colonoscopy after at least two hours of starting Dose 2:

1. Thoroughly mix Dose 2 Pouch A and Dose 2 Pouch B with at least 16 oz of water in the mixing container.
2. Drink all of the solution over the next 30 minutes.
3. Refill the container with at least 16 oz of clear liquid and drink over the next 30 minutes.
4. Consume additional water or clear liquid up to two hours before the colonoscopy. Nothing should be taken two hours prior to the colonoscopy.

Two-day split-dosing regimen

A light breakfast and lunch may be consumed but must be completed three hours before starting Plenvu. In case of severe bloating or stomach pain, each dose of Plenvu can be taken over longer intervals or should be temporarily stopped until they go away.

Dose 1 - In the evening before the colonoscopy, between 4 pm and 8 pm:

1. Thoroughly mix Dose 1 with at least 16 oz of water in the mixing container.
2. Drink all of the solution over the next 30 minutes.
3. Refill the container with at least 16 oz of clear liquids and drink over the next 30 minutes.
4. Consume additional water or clear liquids during the evening.

Dose 2 - The day of the colonoscopy after 12 hours of taking Dose 1, between 4 am and 8 am:

1. Thoroughly mix Dose 2 Pouch A and Dose 2 Pouch B with at least 16 oz of water in the mixing container.
2. Drink all of the solution over the next 30 minutes.
3. Refill the container with at least 16 oz of clear liquid and drink over the next 30 minutes.
4. Consume additional water or clear liquids up to two hours before the colonoscopy. Nothing should be taken two hours prior to the colonoscopy.

If you miss a dose, ask your healthcare provider.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Two doses must be taken prior to the colonoscopy following either the one-day morning dosing or the two-day split-dosing instructions. The packages contain fixed doses and are labelled Dose 1, Dose 2 pouch A, and Dose 2 Pouch B.

If you take too much Plenvu, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Plenvu at room temperature or in the refrigerator. After mixing with water, it may be stored at room temperature or in the refrigerator, but should be used within six hours.
• Keep this and all medicines out of the reach of children.