Prepopik

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The makers of PREPOPIK have introduced a new FDA-approved, ready-to-drink, low volume bowel prep.

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For healthcare providers
Mechanism of
Action (MOA)
Its dual MOA sets PREPOPIK® apart

PREPOPIK® has 3 active ingredients: sodium picosulfate, magnesium oxide, and anhydrous citric acid, which are responsible for its dual mechanism of action—osmotic laxative and stimulant laxative.2

Osmotic laxative

Magnesium oxide and anhydrous citric acid react to create magnesium citrate, which produces osmotic water retention and causes water to be retained in the gastrointestinal tract.2

Free magnesium pulls water into the intestinal lumen, causing a softening of the stool.2

Stimulant laxative

Sodium picosulfate is converted by intestinal bacteria in the colon to an active metabolite that stimulates colonic peristalsis to effectively remove waste by emitting regular, wavelike contractions to clear the colon.2

PREPOPIK® must be stirred for 3 minutes to activate the solution.2

See How PREPOPIK® Works
Why hydrate?

Make sure you instruct your patients on the importance of proper hydration both before and after each dose of PREPOPIK®, and after the procedure.3

Why stir for 3 minutes?

An exothermic reaction takes place over a period of time (up to 3 minutes). This time is necessary in order to complete the reaction and activate the ingredient (magnesium citrate).2

Efficacy
PREPOPIK® provides an effective cleansing of the overall colon and across all colon segments1*

Overall Colon (primary endpoint)1*†

Percentage of patients achieving excellent or good visualization (Split-Dose PREPOPIK® vs Day-Before comparator)

Mid Colon (secondary endpoint)1*†

Percentage of patients achieving successful cleansing in the mid colon (Split-Dose PREPOPIK® vs Day-Before comparator)

Ascending Colon (secondary endpoint)1*†

Percentage of patients achieving successful cleansing in the ascending colon (Split-Dose PREPOPIK® vs Day-Before comparator)

Rectosigmoid Colon (secondary endpoint)1*†

Percentage of patients achieving successful cleansing in the rectosigmoid colon (Split-Dose PREPOPIK® vs Day-Before comparator)

Click/tap
the segments
Overall Colon

*Split-Dose PREPOPIK® was studied in a head-to-head trial to demonstrate noninferiority with the Day-Before Regimen of 2L PEG+E plus 2 x 5 mg bisacodyl tablets. The primary efficacy endpoint was the proportion of patients with successful colon cleansing, defined as bowel preparation with >90% of the mucosa seen and mostly liquid stool, assessed by blinded colonoscopists using a modified Aronchick scale. The secondary endpoints were the quality of cleansing of the ascending, mid (transverse and descending), and rectosigmoid segments of the colon using the Ottawa scale. Patients were considered to be successfully cleansed after administration of prescribed treatment if colon cleansing on the Ottawa Scale was rated excellent, good, or fair.
†Mid colon refers to the transverse and descending segments of the colon.

Overall Colon (primary endpoint)4*†

Percentage of patients achieving excellent or good visualization (Day-Before PREPOPIK® vs Day-Before comparator)

Mid Colon (secondary endpoint)4*†

Percentage of patients achieving successful cleansing in the mid colon (Day-Before PREPOPIK® vs Day-Before comparator)

Ascending Colon (secondary endpoint)4*†

Percentage of patients achieving successful cleansing in the ascending colon (Day-Before PREPOPIK® vs Day-Before comparator)

Rectosigmoid Colon (secondary endpoint)4*†

Percentage of patients achieving successful cleansing in the rectosigmoid colon (Day-Before PREPOPIK® vs Day-Before comparator)

Click/tap
the segments
Overall Colon

*Day-Before PREPOPIK® was studied in a head-to-head trial to demonstrate noninferiority with the Day-Before Regimen of 2L PEG+E plus 2 x 5 mg bisacodyl tablets. The primary efficacy endpoint was the proportion of patients with successful colon cleansing, defined as bowel preparation with >90% of the mucosa seen and mostly liquid stool, assessed by blinded colonoscopists using a modified Aronchick scale. The secondary endpoints were the quality of cleansing of the ascending, mid (transverse and descending), and rectosigmoid segments of the colon using the Ottawa scale. Patients were considered to be successfully cleansed after administration of prescribed treatment if colon cleansing on the Ottawa Scale was rated excellent, good, or fair.
†Mid colon refers to the transverse and descending segments of the colon.

For the Elderly Population
81% of patients 65 or older achieved successful cleansing2
  • The overall incidence of treatment-emergent adverse reactions was similar among patients ≥65 years of age and those <65 years of age
Safety
A proven safety profile in clinical trials2

The most common adverse reactions associated with PREPOPIK® were nausea, headache, and vomiting.*

SEE CLEAR I: Split-Dose Regimen
Adverse
Reaction
PREPOPIK® (N=305) n (%)
2L PEG+E† plus 2 x 5 mg bisacodyl tablets (N=298) n (%)
Nausea
8 (2.6)
11 (3.7)
Headache
5 (1.6)
5 (1.7)
Vomiting
3 (1.0)
10 (3.4)
SEE CLEAR II: Day-Before Regimen
Adverse
Reaction
PREPOPIK® (N=296) n (%)
2L PEG+E† plus 2 x 5 mg bisacodyl tablets (N=302) n (%)
Nausea
9 (3.0)
13 (4.3)
Headache
8 (2.7)
5 (1.7)
Vomiting
4 (1.4)
6 (2.0)

*Data on abdominal bloating, distension, pain/cramping, and watery diarrhea not requiring an intervention were not collected.
†2L PEG+E = Two liters polyethylene glycol plus electrolytes solution administered in a day-before regimen.

Clinical Trials
Trial Designs1,4

The SEE CLEAR I (Split-Dose PREPOPIK®) and SEE CLEAR II (Day-Before PREPOPIK®) studies were phase 3, randomized, multicenter, assessor-blinded, noninferiority studies in patients preparing for colonoscopy. The primary endpoints were the evaluation of overall colon cleansing with PREPOPIK® vs a Day-Before comparator (2L PEG+E plus 2 x 5 mg bisacodyl tablets) using the modified Aronchick scale. The primary efficacy endpoint was the proportion of patients with successful colon cleansing, defined as bowel preparations with >90% of the mucosa seen and mostly liquid stool, assessed by blinded colonoscopists.

In each study, tolerability was measured via a patient questionnaire about orange-flavored PREPOPIK®, which included the questions: “Would you ask your doctor for this preparation again if you needed another colonoscopy?” and “How easy or difficult was it to consume the prescribed bowel preparation?”

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References: 1. Rex DK, Katz PO, Bertiger G, et al. Split-dose administration of a dual-action, low-volume bowel cleanser for colonoscopy: the SEE CLEAR I study. Gastrointest Endosc. 2013;78(1):132-141. 2. PREPOPIK® [Prescribing Information]. Parsippany, NJ: Ferring Pharmaceuticals Inc. 3. Lichtenstein GR, Cohen LB, Uribarri J. Review article: bowel preparation for colonoscopy—the importance of adequate hydration. Aliment Pharmacol Ther. 2007;26(5):633-641. 4. Katz PO, Rex DK, Epstein M, et al. A dual-action, low-volume bowel cleanser administered the day before colonoscopy: results from the SEE CLEAR II study. Am J Gastroenterol. 2013:108(3):401-409.

PREPOPIK® is a registered trademark of Ferring B.V. All other trademarks are the property of their respective owners.
© 2018 Ferring B.V. All rights reserved. PK/546/2018/US(1)

  • In a head-to-head noninferiority clinical trial comparing Split-Dose PREPOPIK® vs a Day-Before comparator (2L PEG+E plus 2 x 5 bisacodyl tablets): 84% of PREPOPIK® patients achieved excellent or good overall visualization of the colon (primary endpoint) vs 74% of patients for the comparator1
  • 96% of patients said they would take PREPOPIK® again and 89% found PREPOPIK® very easy or easy to take vs 55% and 29%, respectively, for the comparator1
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    • Indication and Important Safety Information

    PREPOPIK® for oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults.

    • PREPOPIK® is contraindicated in the following conditions: patients with severely reduced renal function, gastrointestinal obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention, or in patients with a known allergy to any of the ingredients in PREPOPIK®.
    • Patients should be advised on the importance of adequate hydration, and post-colonoscopy lab tests should be considered if a patient develops significant vomiting or signs of dehydration after taking PREPOPIK®. Patients with electrolyte abnormalities should have them corrected before treatment. Use caution when prescribing for patients who are at risk for seizures, or arrhythmias, including those patients with a history of prolonged QT, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy.
    • Caution should be used in patients with impaired gag reflex, regurgitation or aspiration, severe active ulcerative colitis, impaired renal function or patients taking medications that may affect renal function, electrolyte imbalance and/or water retention.
    • Osmotic laxatives may produce colonic mucosal aphthous ulcerations and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of additional stimulant laxatives with PREPOPIK® may increase this risk.
    • PREPOPIK® should not be used if gastrointestinal obstruction or perforation is suspected.
    • PREPOPIK® is not for direct ingestion. Each packet must be dissolved in 5 ounces of cold water and administered at separate times, in addition to additional clear fluids, according to the dosing regimen.
    • In randomized, multicenter, controlled clinical trials, nausea, headache, and vomiting were the most common treatment-emergent adverse reactions (>1%) following PREPOPIK® administration.
    • Oral medication administered within one hour of the start of administration of PREPOPIK® solution may be flushed from the GI tract and the medication may not be absorbed. Prior or concomitant use of antibiotics with PREPOPIK® may reduce its efficacy. Tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine and penicillamine, should be taken at least 2 hours before and not less than 6 hours after administration of PREPOPIK® to avoid chelation with magnesium.

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

    Please see Full Prescribing Information including Patient Medication Guide.

    Please See Important Safety Information and Full Prescribing Information

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