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There is only one GEMTESA – No generic Substitute

Help make a difference for overactive bladder (OAB) patients with GEMTESA2

Broadly Effective2

The ONLY β3 treatment with proven reduction data for all 3 key symptoms of OAB in its label2

  • Urgency
  • Frequency
  • Urge urinary incontinence

Effective for a Wide Range of Patients2,4-6

  • Women and men, regardless of prior therapy
  • Younger and older adults (65+)
  • Patients with hypertension*
  • Patients taking medicines metabolized by the CYP2D6 pathway
  • Male patients with overactive bladder being pharmacologically treated for benign prostatic hyperplasia

Established Safety
in OAB2,4,7

  • The ONLY β3 treatment with no blood pressure warning in its label
    • In a 24-week study of OAB in men being treated for BPH, rates of hypertension were 9.0% with GEMTESA (n=553) vs 8.3% with placebo (n=551)2
  • The ONLY β3 treatment with no drug interaction with CYP2D6 substrates used for common comorbidities2,6

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    Concomitant use of GEMTESA increases digoxin maximal concentrations (Cmax) and systemic exposure as assessed by area under the concentration-time curve. Serum digoxin concentrations should be monitored before initiating and during therapy with GEMTESA and used for titration of the digoxin dose to obtain the desired clinical effect. Continue monitoring digoxin concentrations upon discontinuation of GEMTESA and adjust digoxin dose as needed.2

    *In a 4-week, randomized, placebo-controlled, ambulatory BP study in OAB patients (n=200), daily treatment with GEMTESA 75 mg was not associated with clinically significant changes in BP. 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.2,7

    AUA=American Urological Association; BP=blood pressure; BPH=benign prostatic hyperplasia; SUFU=Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction.

    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.
    • overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH).

    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.
    • overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH).

    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 or 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. Approved Drug Products With Therapeutic Equivalence Evaluations. 44th Edition. US Dept of Health and Human Services; 2024.
    2. GEMTESA. Prescribing Information. Marlborough, MA; Sumitomo Pharma America; 2025.
    3. 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
    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. Varano S, Staskin D, Frankel J, Shortino D, Jankowich R, Mudd PN Jr. Efficacy and safety of once-daily vibegron for treatment of overactive bladder in patients aged ≥65 and ≥75 years: subpopulation analysis from the EMPOWUR randomized, international, phase III study. Drugs Aging. 2021;38(2):137-146. doi:10.1007/s40266-020-00829-z
    6. Data on file. Sumitomo Pharma America, Inc.
    7. Weber MA, Haag-Molkenteller C, King J, Walker A, Mudd PN Jr, 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(2):128-134. doi:10.1097/MBP.0000000000000572
    8. Cameron AP, Chung DE, Dielubanza EJ, et al. The AUA/SUFU guideline on the diagnosis and treatment of idiopathic overactive bladder. J Urol. Published online April 23, 2024. doi:10.1097/JU.0000000000003985. https://www.auajournals.org/doi/10.1097/JU.0000000000003985

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

    Sumitomo Pharma Logo

    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.

    ©2025 Sumitomo Pharma America, Inc. All rights reserved. GEM-US-2482-24 06/25