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FOR YOUR PATIENTS WITH OVERACTIVE BLADDER (OAB)

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GEMTESA® (vibegron) 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.

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There's more to know about GEMTESA, a beta-3 agonist

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Prescribe GEMTESA 1st for OAB symptom relief

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Proven
efficacy data

  • Statistically significant reduction of all 3 key OAB symptoms vs placebo at 12 weeks—including urgency1,2‡
  • First and only beta-3 agonist with proven urgency reduction data in its label1,2
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First and only
beta-3 agonist with
one dose, no titration

  • Once-daily 75-mg dose with no titration, to be taken with or without food and swallowed whole with a glass of water1
  • Crushability. In adults, GEMTESA tablets may be crushed, mixed with a tablespoon (~15 mL) of applesauce and taken immediately with a glass of water1
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First and only
beta-3 agonist with
no blood pressure
warning in its label1

  • No association with clinically significant changes to hypertension or increased blood pressure vs placebo3§||
View the safety data

Additional efficacy data

  • ~43% of all OAB patients taking GEMTESA had a 50% reduction in urgency episodes at Week 12 vs 38% with placebo
  • 52.4% of patients taking GEMTESA had a 75% reduction in urge urinary incontinence (UUI) episodes at Week 12 vs 36.8% with placebo
  • 100% reduction in UUI episodes was reported at 12 weeks (28.8% of patients taking GEMTESA vs 22.5% with placebo) and 52 weeks (40.8% of patients taking GEMTESA vs 34.2% with active control)4,5#

Data were based on unadjusted values for a supportive outcome measure that was a prespecified secondary endpoint in the pivotal EMPOWUR trial.4

#Data were based on a prespecified secondary efficacy endpoint analysis of patients with 100% reduction in UUI from baseline at Week 12 (n=403) and an exploratory endpoint analysis of patients with 100% reduction in UUI from baseline at Week 52 (n=143).4

The 3 key symptoms of OAB are urgency, micturition frequency, and UUI/leakage.2

The efficacy of GEMTESA was evaluated in a pivotal 12-week, double-blind, randomized, placebo- and active-controlled trial in patients with OAB (UUI, urgency, and urinary frequency). For study entry, patients had to have symptoms of OAB for at least 3 months with an average of 8 or more micturitions per day and at least 1 UUI per day, or an average of 8 or more micturitions per day and an average of at least 3 urgency episodes per day. A total of 1515 patients received at least 1 daily dose of placebo (n=540), GEMTESA 75 mg (n=545), or an active-control treatment (n=430). The majority of patients were Caucasian (78%) and female (85%) with a mean age of 60 (range 18 to 93) years.1,4

§In a 12-week pivotal study, hypertension rates for OAB patients taking GEMTESA (n=545) were 1.7% vs 1.7% with placebo (n=540). Increased blood pressure (BP) rates were 0.7% with GEMTESA vs 0.9% with placebo.6

||In a 4-week, randomized, placebo-controlled, ambulatory BP study in OAB patients (n=200), GEMTESA 75 mg was not associated with clinically significant changes in BP. Mean age 59 years; 75% female. At baseline: 35% of subjects had preexisting hypertension; 29% were taking at least 1 concomitant antihypertensive medication.1

Clinically significant reductions in all 3 key OAB symptoms* vs placebo at 12 weeks1,2†:

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Urge urinary
incontinence
episodes

View uui data
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Micturition
frequency

View micturition data
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Urgency
episodes

View urgency data

*The 3 key symptoms of OAB are urgency, micturition frequency, and UUI/leakage.2

The efficacy of GEMTESA was evaluated in a pivotal 12-week, double-blind, randomized, placebo- and active-controlled trial in patients with OAB (UUI, urgency, and urinary frequency). For study entry, patients had to have symptoms of OAB for at least 3 months with an average of 8 or more micturitions per day and at least 1 UUI per day, or an average of 8 or more micturitions per day and an average of at least 3 urgency episodes per day. A total of 1515 patients received at least 1 daily dose of placebo (n=540), GEMTESA 75 mg (n=545), or an active-control treatment (n=430). The majority of patients were Caucasian (78%) and female (85%) with a mean age of 60 (range 18 to 93) years.1

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IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of the product.

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.

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 the product.

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.

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. Edmondson SD, Zhu C, Kar NF, et al. Discovery of vibegron: a potent and selective β3 adrenergic receptor agonist for the treatment of overactive bladder. J Med Chem. 2016;59(2):609-623. doi:10.1021/acs.jmedchem.5b01372 3. 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. 4. Data on file. Sumitomo Pharma America, Inc. 5. 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 6. 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

You are encouraged to report side effects and product complaints associated with GEMTESA by calling 1-833-876-8268.

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is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO PHARMA is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO is a registered trademark of Sumitomo Chemical Co., Ltd., used under license. Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd.

GEMTESA, and the GEMTESA logo are trademarks of Urovant Sciences GmbH, registered in the U.S. and in other countries.

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