SUTAB® (sodium sulfate, magnesium sulfate, and potassium chloride) Tablets 1.479 g/0.225 g /0.188 g

THE TABLET CHOICE IN BOWEL PREPARATION

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Efficacy

of patients in two pivotal trials achieved successful bowel cleansing with SUTAB^2,3*

Tolerability

of patients in one pivotal trial rated SUTAB as tolerable to very easy to consume^2†

52% of all SUTAB and MoviPrep^® patients reported at least one selected gastrointestinal adverse reaction^2,3‡
More SUTAB patients reported experiencing nausea and vomiting than competitor, with ≤1% of these reports considered severe^2,3‡

Compliance

of patients in two pivotal trials were able to complete both doses of preparation^2,3

Patient Acceptance

Nearly 4 out of 5 patients (78%) in one pivotal trial would request SUTAB again for a future colonoscopy^2†

Tablets and packaging not shown actual size.

^*Success was the primary endpoint and was 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.^2,3

MoviPrep is a registered trademark of Velinor AG.

IMPORTANT SAFETY INFORMATION

SUTAB 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. IQVIA, National Prescription Audit Report. December 2023. 2.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. 3. SUTAB^® [package Insert]. Braintree, MA: Braintree Laboratories, Inc. 4. Rex DK, Johnson DA, Anderson JC, Schoenfeld PS, Burke CA, Inadomi JM; American College of Gastroenterology. American College of Gastroenterology guidelines for colorectal cancer screening 2009 (corrected). Am J Gastroenterol. 2009;104(3):739-750.

SUFLAVE IMPORTANT SAFETY INFORMATION

INDICATION

SUFLAVE^™ (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution) is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.

DOSAGE AND ADMINISTRATION

A low residue breakfast may be consumed on the day before colonoscopy, followed by clear liquids up to 2 hours prior to colonoscopy. Administration of two doses of SUFLAVE are required for a complete preparation for colonoscopy. Each bottle must be reconstituted with water before ingestion. Each bottle and one flavor enhancing packet are equivalent to one dose. An additional 16 ounces of water must be consumed after each dose. Stop consumption of all fluids at least 2 hours before the colonoscopy.

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 SUFLAVE.

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; Colonic mucosal ulcerations: Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease; Patients with renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider laboratory testing; Suspected GI obstruction or perforation: Rule out the diagnosis before administration; Patients at risk for aspiration: Observe during administration; Hypersensitivity reactions, including anaphylaxis: Inform patients to seek immediate medical care if symptoms occur.

ADVERSE REACTIONS

Most common adverse reactions (≥2%) are: nausea, abdominal distension, vomiting, abdominal pain, and headache.

DRUG INTERACTIONS

Drugs that increase risk of fluid and electrolyte imbalance.

View the Full Prescribing Information and Medication Guide.

References: 1. Rex DK, Anderson JC, Butterfly LF, et al. Quality indicators for colonoscopy. Gastrointest Endosc. 2024;100(3):352-381. doi:10.1016/j.gie.2024.04.2905 2. SUTAB [package insert]. Braintree, MA: Braintree Laboratories, Inc. 3. 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 4. SUFLAVE [package insert]. Braintree, MA: Braintree Laboratories, Inc. 5. Bhandari R, Goldstein M, Mishkin DS, et al. Comparison of a novel, flavor-optimized, polyethylene glycol and sulfate bowel preparation with oral sulfate solution in adults undergoing colonoscopy. J Clin Gastroenterol. 2023;57(9):920-927. doi:10.1097/MCG.0000000000001894