MOVIPREP® (polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid for oral solution)

MOVIPREP® (polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid for oral solution)

MOVIPREP®

MoviPrep (polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid for oral solution) is an osmotic laxative consisting of 4 pouches (2 of Pouch A and 2 of Pouch B) containing white to yellow powder for reconstitution.

Each Pouch A contains 100 grams of polyethylene glycol (PEG) 3350, 7.5 grams of sodium sulfate, 2.691 grams of sodium chloride, and 1.015 grams of potassium chloride, plus the following excipients: aspartame (sweetener), acesulfame potassium (sweetener), and lemon flavoring containing citral, lemon oil and lime oil; maltodextrin; xanthan gum; and vitamin E. Pouch A contains 111.9 g of powder for oral solution.

Each Pouch B contains 4.7 grams of ascorbic acid and 5.9 grams of sodium ascorbate. Pouch B contains 10.6 g of powder for oral solution.

When 1 Pouch A and 1 Pouch B are dissolved together in water to a volume of 1 liter, MoviPrep (polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) is an oral solution having a lemon taste.

The entire, reconstituted, 2-liter MoviPrep colon preparation contains 200 grams of polyethylene glycol (PEG) 3350, 15 grams of sodium sulfate, 5.38 grams of sodium chloride, 2.03 grams of potassium chloride, 9.4 grams of ascorbic acid, and 11.8 grams of sodium ascorbate plus the following excipients: aspartame (sweetener), acesulfame potassium (sweetener), and lemon flavoring.

A mixing container for reconstitution is enclosed.

Phenylketonurics: Contains Phenylalanine 131 mg per treatment.

INDICATIONS AND USAGE

MoviPrep® is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults.

Mechanism of Action

The primary mode of action is osmotic action of polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid, which induce a laxative effect. The physiological consequence is increased water retention in the lumen of the colon, resulting in loose stools.

DOSAGE AND ADMINISTRATION

  • Correct fluid and electrolyte abnormalities before treatment with MoviPrep
  • Two doses of MoviPrep are required for a complete preparation for colonoscopy. The time interval between the two doses depends on the regimen prescribed and the planned timing of the colonoscopy procedure.
  • The “Split-Dose” is the preferred method and consists of two separate doses: the first dose is taken the evening before the colonoscopy, and the second dose is taken the next day, the morning of the day of the colonoscopy
  •  The “Evening Only” is the alternative method and consists of two separate doses: both doses are taken in the evening before the day of the colonoscopy, with a minimum of 1.5 hours between the start of the first dose and the start of the second dose
  • Both MoviPrep dosing regimens require administration of MoviPrep using the mixing container provided to reconstitute the contents of Pouch A and B with water to the Fill Line. Do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container
  • Additional clear liquids (including water) must be consumed in both dosing regimens
  • Consume only clear liquids (no solid food) from the start of MoviPrep treatment until after the colonoscopy.
  • Do not eat or drink alcohol, milk, anything colored red or purple or any other foods containing pulp material.
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  • Do not take other laxatives while taking MoviPrep
  • Do not take oral medications within 1 hour before or after starting each dose of MoviPrep.
  • Ensure completion of Dose 2, including all additional liquids, at least 2 hours before the colonoscopy.
  • Storage: After reconstitution, store MoviPrep solution in an upright position and keep refrigerated. Use within 24 hours after it is mixed in water.

Two-Day Split-Dosing Regimen (Preferred Method)

The Two-Day Split-Dosing regimen is the preferred dosing method.

Instruct adult patients that on the day before the clinical procedure, they can consume breakfast, followed by a light lunch (no solid foods), and clear soup and/or plain yogurt for dinner, which must be completed at least 1 hour prior to the start of the first MoviPrep dose.

Instruct adult patients to take two separate doses in conjunction with fluids as follows:

Dose 1 – In the evening before the colonoscopy, approximately 10 to 12 hours before Dose 2:

  1. Empty the contents of 1 Pouch A and 1 Pouch B into the mixing container that comes with MoviPrep.
  2. Add lukewarm water to the Fill Line on the mixing container (32 fluid ounces). Do not add other ingredients to the MoviPrep solution.
  3. Thoroughly mix with a spoon or shake with lid on securely until the contents of Pouch A and B are completely dissolved.
  4. Drink 8 ounces of the solution every 15 minutes. This should take about 1 hour. Be sure to drink all the solution.
  5. Refill the mixing container halfway to the Fill Line (at least 16 ounces) with a clear liquid and drink all this liquid before going to bed.

Dose 2 – Take next morning, on the day of the colonoscopy, approximately 12 hours after the start of Dose 1 and at least 3 ½ hours prior to colonoscopy:

  1. Empty the contents of 1 Pouch A and 1 Pouch B into the mixing container that comes with MoviPrep.
  2. Add lukewarm water to the Fill Line on the mixing container (32 fluid ounces). Do not add other ingredients to the MoviPrep solution.
  3. Thoroughly mix with a spoon or shake with lid on securely until the contents of Pouch A and B are completely dissolved.
  4. Drink 8 ounces of the solution every 15 minutes. This should take about 1 hour. Be sure to drink all of the solution.
  5. Refill the mixing container halfway to the Fill Line (at least 16 ounces) with a clear liquid and drink all this liquid at least 2 hours before the colonoscopy.
  6. Consume additional water or clear liquids up to 2 hours before the colonoscopy or as prescribed by your healthcare provider. Then stop drinking liquids until after the colonoscopy.

Stop drinking MoviPrep temporarily or drink each portion at longer intervals if severe bloating, abdominal discomfort or distention occurs, until these symptoms resolve.

One-Day Evening Only Dosing Regimen (Alternative Method)

The One-Day Evening Only regimen is the alternative dosing method for patients for whom the Split-Dosing regimen is inappropriate.

Instruct adult patients that on the day before the clinical procedure, they can consume breakfast, followed by a light lunch (no solid foods), and clear soup and/or plain yogurt for dinner, which must be completed at least 1 hour prior to the start of the first MoviPrep dose.

Instruct adult patients to take two separate doses in conjunction with fluids as follows:

Dose 1 – At least 3 ½ hours before bedtime the evening before the colonoscopy:

  1. Empty the contents of 1 Pouch A and 1 Pouch B into the mixing container that comes with MoviPrep.
  2. Add lukewarm water to the Fill Line on the mixing container (32 fluid ounces). Do not add other ingredients to the MoviPrep solution.
  3. Thoroughly mix with a spoon or shake with lid on securely until the contents of Pouch A and B are completely dissolved.
  4. Drink 8 ounces of the solution every 15 minutes. This should take about 1 hour. Be sure to drink all the solution.

Dose 2 – At least 1 ½ hours after starting Dose 1 on the evening before the colonoscopy:

  1. Empty the contents of 1 Pouch A and 1 Pouch B into the mixing container that comes with MoviPrep.
  2.  Add lukewarm water to the Fill Line on the mixing container (32 fluid ounces). Do not add other ingredients to the MoviPrep solution.
  3. Thoroughly mix with a spoon or shake with lid on securely until the contents of Pouch A and B are completely dissolved.
  4. Drink 8 ounces of the solution every 15 minutes. This should take about 1 hour. Be sure to drink all of the solution.
  5. Refill the mixing container to the Fill Line (32 fluid ounces) with a clear liquid and drink all this liquid before going to bed.
  6. Consume additional water or clear liquids up to 2 hours before the colonoscopy or as prescribed by your healthcare provider. Then stop drinking liquids until after the colonoscopy.

Stop drinking MoviPrep temporarily or drink each portion at longer intervals if severe bloating, abdominal discomfort or distention occurs, until these symptoms resolve.

CONTRAINDICATIONS

MoviPrep is contraindicated in the following conditions:

  • Gastrointestinal (GI) obstruction
  • Bowel perforation
  • Gastric retention
  • Ileus
  • Toxic colitis or toxic megacolon
  • Hypersensitivity to any ingredient in MoviPrep

WARNINGS AND PRECAUTIONS

Serious Fluid and Electrolyte Abnormalities: Advise patients to hydrate adequately before, during, and after the use of MoviPrep. If a patient develops significantvomiting or signs of dehydration after taking MoviPrep, consider performing post-colonoscopy lab tests (electrolytes,creatinine, and BUN).

Bowel preparations can cause fluid and electrolyte disturbances, which can lead to serious adverse reactions including cardiac arrhythmias, seizures, and renal impairment. Correct fluid and electrolyte abnormalities before treatment with MoviPrep. MoviPrep should be used with caution in patients using concomitant medications that increase the risk of electrolyte abnormalities [such as diuretics, angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs)] or in patients with known or suspected hyponatremia.

Cardiac Arrhythmias: There have been rare reports of serious arrhythmias (including atrial fibrillation) associated with the use of ionic osmoticlaxative products for bowel preparation. These occur predominantly in patients with underlying cardiac risk factors andelectrolyte disturbances. Use caution when prescribing MoviPrep for patients at increased risk of arrhythmias (e.g.,patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina,congestive heart failure, cardiomyopathy, or electrolyte imbalance). Consider pre-dose and post-colonoscopy ECGs inpatients at increased risk of serious cardiac arrhythmias.

Seizures: There have been rare reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use ofbowel preparation products in patients with no prior history of seizures. The seizure cases were associated with electrolyteabnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. Theneurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.

Use in Patients with Renal Impairment: Use MoviPrep with caution in patients with renal impairment or patients taking concomitant medications that affect renalfunction (such as diuretics, ACE inhibitors, angiotensin receptor blockers, or nonsteroidal anti-inflammatory drugs). These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration before, during, and after use of MoviPrep, and consider performing pre-dose and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients.

Colonic Mucosal Ulceration, Ischemic Colitis and Ulcerative Colitis: Osmotic laxatives may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious casesof ischemic colitis requiring hospitalization. Concurrent use of stimulant laxatives and MoviPrep may increase the risk ofmucosal ulceration or ischemic colitis and is not recommended. Consider the potential for mucosal ulcerations resultingfrom the bowel preparation when interpreting colonoscopy findings in patients with known or suspected inflammatorybowel disease.

Use in Patients with Significant Gastrointestinal Disease: If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out theseconditions before administering MoviPrep.

Use with caution in patients with severe ulcerative colitis.

Aspiration: Patients with impaired gag reflex or other swallowing abnormalities are at risk for regurgitation or aspiration ofMoviPrep. Observe these patients during the administration of MoviPrep. Use with caution in these patients.

Glucose-6-Phosphate Dehydrogenase (G6PD) Deficiency: Since MoviPrep contains sodium ascorbate and ascorbic acid, MoviPrep should be used with caution in patients withglucose-6-phosphate dehydrogenase (G6PD) deficiency, especially G6PD deficiency patients with an active infection,with a history of hemolysis, or taking concomitant medications known to precipitate hemolytic reactions.

Risks in Patients with Phenylketonuria: Phenylalanine can be harmful to patients with phenylketonuria (PKU). MoviPrep contains phenylalanine, a component ofaspartame. Each MoviPrep treatment contains 131 mg of phenylalanine (after hydrolysis of the aspartame moleculein vivo to aspartic acid and phenylalanine). Before prescribing MoviPrep to a patient with PKU, consider the combineddaily amount of phenylalanine from all sources, including MoviPrep.

Hypersensitivity Reactions: MoviPrep contains polyethylene glycol (PEG) and lemon flavoring (containing citral, lemon and lime oil; maltodextrin;xanthan gum; and vitamin E) and may cause serious hypersensitivity reactions including anaphylaxis, angioedema, rash,urticaria, and pruritus. Inform patients of thesigns and symptoms of anaphylaxis and instruct them to seek immediate medical care should signs and symptoms occur.

DRUG INTERACTIONS

Drugs That May Increase Risks due to Fluid and Electrolyte Abnormalities: Use caution when prescribing MoviPrep for patients with conditions and/or who are using medications that increase therisk for fluid and electrolyte disturbances or may increase the risk of renal impairment, seizures, arrhythmias, or QT prolongation in the setting of fluid and electrolyte abnormalities.

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Consider additional patient evaluations as appropriate.

Potential for Reduced Drug Absorption: MoviPrep can reduce the absorption of other co-administered drugs. Administer oral medications at least 1 hour beforethe start of administration of each dose of MoviPrep.

Stimulant Laxatives: Concurrent use of stimulant laxatives and MoviPrep may increase the risk of mucosal ulceration or ischemic colitis.Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking MoviPrep.

USE IN SPECIFIC POPULATIONS

Pregnancy: There are no available data on MoviPrep in pregnant women to inform a drug-associated risk for adverse developmentaloutcomes. Animal reproduction studies have not been conducted with MoviPrep.

Lactation: There are no data available on the presence of MoviPrep in human milk, the effects of the drug on the breastfed child, orthe effects of the drug on milk production. The lack of clinical data during lactation precludes a clear determination of therisk of MoviPrep to a child during lactation; therefore, the developmental and health benefits of breastfeeding should beconsidered along with the mother’s clinical need for MoviPrep and any potential adverse effects on the breastfed childfrom MoviPrep or from the underlying maternal condition.

Pediatric Use: The safety and effectiveness of MoviPrep in pediatric patients have not been established.

Geriatric Use: Of the 413 patients in clinical trials receiving MoviPrep, 91 (22%) patients were aged 65 or older, while 25 (6%) patientswere over 75 years of age. No overall differences in safety or effectiveness were observed between geriatric patients andyounger patients, and other reported clinical experience has not identified differences in responses between geriatricpatients and younger patients. However, elderly patients are more likely to have decreased hepatic, renal or cardiacfunction and may be more susceptible to adverse reactions resulting from fluid and electrolyte abnormalities.

Renal Impairment: Use MoviPrep with caution in patients with renal impairment or patients taking concomitant medications that may affectrenal function. These patients may be at risk for renal injury. Advise these patients of theimportance of adequate hydration before, during and after the use of MoviPrep, and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients.

OVERDOSAGE

Overdosage of more than the recommended dose of MoviPrep may lead to severe electrolyte disturbances, including hyponatremia and/or hypokalemia, as well as dehydration and hypovolemia, with signs and symptoms of these disturbances. Certain severe electrolyte disturbances may lead to cardiac arrhythmias, seizures, and renal failure.

Monitor for fluid and electrolyte disturbances and treat symptomatically.

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