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Important Safety Information | Full Prescribing Information / Medication Guide
Important Safety Information | Full Prescribing Information / Medication Guide

THE TABLET CHOICE IN BOWEL PREPARATION

SUTAB
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  1. NO SODIUM PHOSPHATE3
  2. SAFE AND EFFECTIVE3,4
  3. ACG-RECOMMENDED SPLIT-DOSE REGIMEN5
    • Two SUTAB doses are required for a complete preparation3
    • Dose 1 consists of 12 tablets and 16 oz of water
    • Dose 2 consists of 12 tablets and 16 oz of water
    • Each dose is followed by two additional 16 oz of water
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92% OF PATIENTS IN TWO PIVOTAL TRIALS ACHIEVED SUCCESSFUL BOWEL CLEANSING WITH SUTAB3,4†
91% OF PATIENTS IN ONE PIVOTAL TRIAL RATED SUTAB AS TOLERABLE TO VERY EASY TO CONSUME4‡
  • 52% of all SUTAB and MoviPrep® patients reported at least one selected gastrointestinal adverse reaction3,4§
  • More SUTAB patients reported experiencing nausea and vomiting than competitor, with ≤1% of these reports considered severe4§
78% OF PATIENTS IN ONE PIVOTAL TRIAL WOULD REQUEST SUTAB AGAIN FOR A FUTURE COLONOSCOPY4‡
*Coverage is subject to change. As of October 2022, SUTAB has unrestricted coverage for Anthem commercially insured patients on essential, national, and traditional formularies. As of January 1, 2023, SUTAB is covered as a preferred brand for AARP Medicare RX Preferred, AARP Medicare Complete, and UnitedHealthcare Medicare Rx for Groups G and H.
†Success was the primary efficacy endpoint and defined in non-inferiority trials as an overall cleansing assessment of 3 (good) or 4 (excellent) by the blinded endoscopist; scores were assigned following completion of the colonoscopy.
‡Patients completed a preference questionnaire following completion of study drug to capture their perceptions of the preparation experience. This questionnaire has not undergone formal validation.
§Patients were queried for selected gastrointestinal adverse reactions of upper abdominal pain, abdominal distension, nausea, and vomiting following completion of study drug, rating the intensity as mild, moderate, or severe.3,4
ACG=American College of Gastroenterology
MoviPrep is a registered trademark of Velinor AG.
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IMPORTANT SAFETY INFORMATION

INDICATION
SUTAB® (sodium sulfate, magnesium sulfate, potassium chloride) tablets for oral use is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.

CONTRAINDICATIONS
Use is contraindicated in the following conditions: gastrointestinal obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention, hypersensitivity to any ingredient in SUTAB.

DOSAGE AND ADMINISTRATION
A low residue breakfast may be consumed. After breakfast, only clear liquids may be consumed until after the colonoscopy. Administration of two doses of SUTAB (24 tablets) are required for a complete preparation for colonoscopy. Twelve (12) tablets are equivalent to one dose. Each SUTAB bottle contains a desiccant. Remove and discard the desiccant from both bottles the evening prior to the colonoscopy. Water must be consumed with each dose of SUTAB and additional water must be consumed after each dose. Complete all SUTAB tablets and required water at least 2 hours before colonoscopy.

WARNINGS AND PRECAUTIONS
Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications and consider laboratory assessments prior to and after each use; Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk; Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold; Patients with renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider laboratory testing; Colonic mucosal ulcerations: Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease. Suspected GI obstruction or perforation: Rule out the diagnosis before administration. Hypersensitivity reactions, including anaphylaxis: Inform patients to seek immediate medical care if symptoms occur. Risk of Gastrointestinal Complications with Ingestion of Desiccant: Postmarketing reports of ingestion of the desiccant along with SUTAB tablets has been reported and may be associated with risk of gastrointestinal complications and/or choking.

ADVERSE REACTIONS
Most common gastrointestinal adverse reactions are: nausea, abdominal distension, vomiting, and upper abdominal pain.

DRUG INTERACTIONS
Drugs that increase risk of fluid and electrolyte imbalance.

View the Full Prescribing Information and Medication Guide.

References: 1. Data on file. Breakaway Partners, LLC. 2. IQVIA, National Prescription Audit Report. December 2023. 3. SUTAB [package insert]. Braintree, MA: Braintree Laboratories, Inc. 4. Di Palma JA, Bhandari R, Cleveland M, et al. A safety and efficacy comparison of a new sulfate-based tablet bowel preparation versus a PEG and ascorbate comparator in adult subjects undergoing colonoscopy. Am J Gastroenterol. 2021;116(2):319-328. doi: 10.14309/ajg.0000000000001020. 5. Rex DK, Johnson DA, Anderson JC, et al; American College of Gastroenterology. American College of Gastroenterology guidelines for colorectal cancer screening 2009 [corrected]. Am J Gastroenterol. 2009;104(3):739-750. 6. Rex DK, Boland CR, Dominitz JA, et al. Colorectal cancer screening: recommendations for physicians and patients from the US Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2017;112(7):1016-1030. doi:10.1038/ajg.2017.174. 7. Rex DK, Schoenfeld PS, Cohen J, et al. Quality indicators for colonoscopy. Gastrointest Endosc. 2015;81(1):31-53. 8. Data on file. Braintree Laboratories, Inc. Braintree, MA. 9. SUFLAVE [package insert]. Braintree, MA: Braintree Laboratories, Inc. 10. SUPREP Bowel Prep Kit [package insert]. Braintree, MA: Braintree Laboratories, Inc. 11. Plenvu [package insert]. Bridgewater, NJ: Bausch Health LLC. 12. Clenpiq [package insert]. Parsippany, NJ: Ferring Pharmaceuticals, Inc. 13. Rex DK, Di Palma JA, Rodriguez R, et al. A randomized clinical study comparing reduced-volume oral sulfate solution with standard 4-liter sulfate-free electrolyte lavage solution as preparation for colonoscopy. Gastrointest Endosc. 2010;72(2):328-336. 14. Matro R, Daskalakis C, Negoianu D, et al. Randomised clinical trial: polyethylene glycol 3350 with sports drink vs polyethylene glycol with electrolyte solution as purgatives for colonoscopy—the incidence of hyponatraemia. Aliment Pharmacol Ther. 2014;40(6):610-619.

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