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DEMONSTRATED SAFETY AND
TOLERABILITY WITH GEMTESA

Adverse reactions at 12 weeks and at 52 weeks with an incidence of
≥2% compared with and exceeding control arm^1-3*

AT 12 WEEKS^1,2

AT 52 WEEKS³

GEMTESA
n=545

Placebo
n=540

GEMTESA
n=273

Active Control
n=232

HYPERTENSION

HYPERTENSION

1.7%

1.7%

8.8%

8.6%

HEADACHE

HEADACHE

4.0%

2.4%

5.5%

3.9%

NASOPHARYNGITIS

NASOPHARYNGITIS

2.8%

1.7%

4.8%

5.2%

DIARRHEA

DIARRHEA

2.2%

1.1%

4.8%

1.7%

CONSTIPATION

CONSTIPATION

1.7%

1.3%

3.7%

2.6%

NAUSEA

NAUSEA

2.2%

1.1%

3.7%

3.0%

UPPER RESPIRATORY TRACT INFECTION

UPPER RESPIRATORY TRACT
INFECTION

2.0%

0.7%

3.7%

0.4%

BRONCHITIS

BRONCHITIS

2.9%

1.3%

*Includes all AEs with an incidence of ≥2% in the GEMTESA group and greater than in the placebo group.^1,3

At 52
weeks,98.3^% of patients in the GEMTESA (vibegron) arm of the extension trial did not need to discontinue treatment due to AEs^4†

^†The total number of patients in the GEMTESA arm of the extension trial included in this safety assessment was 273 (safety set extension).³

GEMTESA is the first and only beta-3 agonist with no clinically significant impact on blood pressure^1,5

The prevalence of hypertension increases with age. By age 45, nearly half of women and men have hypertension^6‡

Hypertension and increased BP rates for GEMTESA compared with placebo for up to 12 weeks²

GEMTESA
n (%)

PLACEBO
n (%)

NUMBER OF PATIENTS

545

540

HYPERTENSION

9 (1.7)

9 (1.7)

BP INCREASE

4 (0.7)

5 (0.9)

In a 4-week, randomized, placebo-controlled, ambulatory BP study in overactive bladder (OAB) patients (n=200), daily treatment with GEMTESA 75 mg was not associated with clinically significant changes in blood pressure. Subjects enrolled in this study had a mean age of 59 years and 75% were female. Thirty-five percent of subjects had preexisting hypertension at baseline and 29% of all subjects were taking at least 1 concomitant antihypertensive medication.¹

^‡Based on NHANES data conducted from 2011 to 2014, including 9623 participants.⁶
AE=adverse event; BP=blood pressure.

But wait, there's more!

GEMTESA is the first and only beta-3 agonist without a blood pressure warning in its label^1,5

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of GEMTESA. Hypersensitivity reactions, such as angioedema, have occurred.

WARNINGS AND PRECAUTIONS

Urinary Retention

Urinary retention has been reported in patients taking GEMTESA. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for the treatment of OAB. Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction and patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention.

Angioedema

Angioedema of the face and/or larynx has been reported with GEMTESA. Angioedema has been reported to occur hours after the first dose or after multiple doses. Angioedema, associated with upper airway swelling, may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, immediately discontinue GEMTESA and provide appropriate therapy and/or measures necessary to ensure a patent airway.

ADVERSE REACTIONS

Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection.

INDICATIONS AND USAGE

GEMTESA^® is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of GEMTESA. Hypersensitivity reactions, such as angioedema, have occurred.

WARNINGS AND PRECAUTIONS

Urinary Retention

Urinary retention has been reported in patients taking GEMTESA. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for the treatment of OAB. Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction and patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention.

Angioedema

Angioedema of the face and/or larynx has been reported with GEMTESA. Angioedema has been reported to occur hours after the first dose or after multiple doses. Angioedema, associated with upper airway swelling, may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, immediately discontinue GEMTESA and provide appropriate therapy and/or measures necessary to ensure a patent airway.

ADVERSE REACTIONS

Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection.

Please see full Prescribing Information.

References: 1. GEMTESA. Prescribing Information. Marlborough, MA; Sumitomo Pharma America; 2023. 2. Data on file. Sumitomo Pharma America, Inc. 3. Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd PN Jr. Once-daily vibegron 75 mg for overactive bladder: long-term safety and efficacy from a double-blind extension study of the international phase 3 trial (EMPOWUR). J Urol. 2021;205(5):1421-1429. doi:10.1097/JU.0000000000001574 4. Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd PN Jr. International phase III, randomized, double-blind, placebo and active controlled study to evaluate the safety and efficacy of vibegron in patients with symptoms of overactive bladder: EMPOWUR. J Urol. 2020;204(2):316-324. doi:10.1097/JU.0000000000000807 5. Weber MA, Haag-Molkenteller C, King J, Walker A, Mudd PN, White WB. Effects of vibegron on ambulatory blood pressure in patients with overactive bladder: results from a double-blind, placebo-controlled trial. Blood Press Monit. 2022;27:128-134. 6. Virani SS, Alonso A, Benjamin EJ, et al. Heart disease and stroke statistics—2020 update: a report from the American Heart Association. Circ. 2020;141(9):e139-e596. doi:10.116/CIR0000000000000757