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Tolerability: General and Elderly Populations

91%
of patients IN ONE PIVOTAL TRIAL rated sutab as tolerable to very easy to consume2*
Patient Preference Data2
How was your overall experience?
72%
said it was good or excellent
How easy was it to take SUTAB?
65%
said it was easy or 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.1† 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.2
Would you request SUTAB again?
78%
of patients in one pivotal trial would request for a future colonoscopy 2
*Patients completed a preference questionnaire following completion of study drug to capture their perceptions of the preparation experience.
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.2

IN ALL GROUPS, MOST SYMPTOMS WERE MILD1,2

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).2
Proportion of subjects reporting a specific severity out of those that reported that specific symptom.1

MoviPrep is a registered trademark of Velinor AG.

Symptom definitions1,2

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 vomiting1,2
  • Of the 471 patients who received SUTAB in pivotal clinical trials1:
    — 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 patients1
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).2
Proportion of subjects reporting a specific severity out of those that reported that specific symptom.1

Prepopik is a registered trademark of Ferring B.V.

Symptom definitions1,2

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 pain1,2
  • Of the 471 patients who received SUTAB in pivotal clinical trials1:
    — 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 patients1
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.

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. 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.

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

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. Suspected GI obstruction or perforation: Rule out the diagnosis before administration.

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. SUTAB® [package insert]. Braintree, MA: Braintree Laboratories, Inc; 2020. 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. Published online November 6, 2020. doi: 10.14309/ajg.0000000000001020. 3. 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. 4. Rex DK, Schoenfeld PS, Cohen J, et al. Quality indicators for colonoscopy. Gastrointest Endosc. 2015;81(1):31-53. 5. Data on file. Braintree Laboratories, Inc. Braintree, MA. 6. SUPREP Bowel Prep Kit [package insert]. Braintree, MA: Braintree Laboratories, Inc; 2020. 7. Plenvu [package insert]. Bridgewater, NJ: Bausch Health LLC; 2019. 8. Clenpiq [package insert]. Parsippany, NJ: Ferring Pharmaceuticals, Inc; 2019. 9. 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. 10. 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.