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Tolerability: General and Elderly Populations

91%

of patients IN ONE PIVOTAL TRIAL rated sutab as tolerable to very easy to consume^4*

Patient Preference Data⁴

How was your overall experience?

72%

said it was good or excellent

How easy was it to take SUTAB?

65%

said it was easy to very easy

How did SUTAB compare with other preps you’ve taken?

65%

said it was better

Fifty-two percent of all SUTAB and MoviPrep patients reported at least one selected gastrointestinal adverse reaction. More SUTAB patients reported experiencing nausea and vomiting than the competitor, with ≤1% of these reports considered severe.^3† Four percent of SUTAB patients reported they had a bad preparation experience, 3% reported that the prep was very difficult to consume, and 15% said it was worse than their prior bowel prep experience.⁴

Would you request SUTAB again?

78%

of patients in one pivotal trial would request it for a future colonoscopy ⁴^*

^*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 abdominal pain, abdominal distension, nausea, and vomiting following completion of study drug, rating the intensity as mild, moderate, or severe.^3,4

IN ALL GROUPS, MOST SYMPTOMS WERE MILD^3,4

Study 1: SUTAB and MoviPrep^® GI Symptoms by Severity

Solicited
Symptoms^*

SUTAB (N=281)

MoviPrep (N=271)

% Nausea

Mild
Moderate
Severe

48%

% Overall^†

% by Symptom^‡

35

71

13

27

1

2

26%

% Overall^†

% by Symptom^‡

20

77

6

23

0

0

% Abdominal
distension

Mild
Moderate
Severe

29%

% Overall^†

% by Symptom^‡

21

68

9

30

0

1

22%

% Overall^†

% by Symptom^‡

16

71

6

29

0

0

% Vomiting

Mild
Moderate
Severe

23%

% Overall^†

% by Symptom^‡

11

48

12

52

0

0

5%

% Overall^†

% by Symptom^‡

3

46

3

54

0

0

% Upper
abdominal pain

Mild
Moderate
Severe

16%

% Overall^†

% by Symptom^‡

11

65

6

35

0

0

18%

% Overall^†

% by Symptom^‡

13

71

6

29

0

0

^*During Studies 1 and 2, patients were queried for selected GI adverse reactions using a standard questionnaire, following completion of study prep.

^†Proportion of subjects reporting a specific symptom/severity out of all subjects who took that prep (N).⁴

^‡Proportion of subjects reporting a specific severity out of those that reported that specific symptom.³

MoviPrep is a registered trademark of Velinor AG.

Symptom definitions^3,4

Mild/barely noticeable: Does not influence functioning, causing no limitations of usual activities

Moderate: Makes participant uncomfortable, influences functioning, causing some limitations of usual activities

Severe: Severe discomfort, treatment needed, severe and undesirable, causing inability to carry out usual activities

SUTAB scored lower (worse) than the comparator in the symptom-rating categories for nausea and vomiting^3,4
Of the 471 patients who received SUTAB in pivotal clinical trials³:

— 32% (n=150) were 65 years of age or older

— 5% (n=25) were 75 years of age or older
No differences in safety or effectiveness of SUTAB were observed between geriatric and younger patients³

Study 2: SUTAB and Prepopik^® GI Symptoms by Severity

Solicited
Symptoms^*

SUTAB (N=190)

Prepopik (N=199)

% Nausea

Mild
Moderate
Severe

52%

% Overall^†

% by Symptom^‡

39

74

11

20

3

6

18%

% Overall^†

% by Symptom^‡

17

94

1

6

0

0

% Abdominal
distension

Mild
Moderate
Severe

34%

% Overall^†

% by Symptom^‡

25

73

9

27

0

0

15%

% Overall^†

% by Symptom^‡

11

69

5

31

0

0

% Vomiting

Mild
Moderate
Severe

16%

% Overall^†

% by Symptom^‡

9

53

8

47

0

0

2%

% Overall^†

% by Symptom^‡

1

33

1

67

0

0

% Upper
abdominal pain

Mild
Moderate
Severe

23%

% Overall^†

% by Symptom^‡

18

82

4

16

1

2

13%

% Overall^†

% by Symptom^‡

13

100

1

0

1

0

^*During Studies 1 and 2, patients were queried for selected GI adverse reactions using a standard questionnaire, following completion of study prep.

^†Proportion of subjects reporting a specific symptom/severity out of all subjects who took that prep (N).⁴

^‡Proportion of subjects reporting a specific severity out of those that reported that specific symptom.³

Prepopik is a registered trademark of Ferring B.V.

Symptom definitions^3,4

Mild/barely noticeable: Does not influence functioning, causing no limitations of usual activities

Moderate: Makes participant uncomfortable, influences functioning, causing some limitations of usual activities

Severe: Severe discomfort, treatment needed, severe and undesirable, causing inability to carry out usual activities

SUTAB scored lower (worse) than the comparator in the symptom-rating categories for nausea, abdominal distention, vomiting, and upper abdominal pain^3,4
Of the 471 patients who received SUTAB in pivotal clinical trials³:

— 32% (n=150) were 65 years of age or older

— 5% (n=25) were 75 years of age or older
No differences in safety or effectiveness of SUTAB were observed between geriatric and younger patients³

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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