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ONLY GEMTESA IS PROVEN TO TREAT OAB SYMPTOMS* IN MEN BEING PHARMACOLOGICALLY TREATED FOR BPH1,2

Help male patients strike against all 3 key symptoms* of OAB1,2

Do urinary-related issues persist for your patients being treated for BPH? Make a difference for your patients — add GEMTESA to a BPH treatment regimen to help reduce OAB symptoms.

*OAB symptoms include urgency, frequency, and UUI.4

Relief from urgency is within reach2

Urgency episodes at 12 weeks, Graph

LS=least squares; SE=standard error; UUI=urge urinary incontinence.

Proven safety profile in male patients being treated for BPH1,2

Adverse reactions, exceeding placebo rate, reported in ≥2% of patients treated with GEMTESA 75 mg for up to 24 weeks

Adverse reactions up to 24 weeks, Table

97.1%

OF PATIENTS TAKING GEMTESA completed the study without discontinuing treatment due to AEs2

GEMTESA was also evaluated for long-term safety in a 28-week extension study in 276 patients who completed the 24-week study. Of the 276 patients who received GEMTESA 75 mg once daily in the extension study, 124 patients were treated for a total of 1 year. There were no additional adverse reactions reported that were not already reported in the pivotal and extension studies.1

† Defined as an average systolic blood pressure (SBP) ≥140 mm Hg or diastolic BP (DBP) ≥90 mm Hg on 3 assessments at two consecutive visits, in non-hypertensive patients.1

† Defined as an average increase of SBP ≥20 mm Hg or DBP ≥10 mm Hg on 3 assessments at two consecutive visits, or the initiation or increase in dose of antihypertensive medications at any visit, in hypertensive patients.1

GEMTESA is the only β3 treatment with no drug interaction with commonly prescribed CYP2D6-metabolized agents, including tamsulosin1,3

Concomitant use of GEMTESA increases digoxin maximal concentrations (Cmax) and systemic exposure as assessed by area under the concentration-time curve (AUC). 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.1

Make GEMTESA your first choice for effective OAB management in men — regardless of if they are being treated for BPH1,2

AE=adverse event; BPH=benign prostatic hyperplasia; OAB=overactive bladder.

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. GEMTESA. Prescribing Information. Marlborough, MA; Sumitomo Pharma America; 2025.
  2. Staskin D, Owens-Grillo J, Thomas E, Rovner E, Cline K, Mujais S. Efficacy and safety of vibegron for persistent symptoms of overactive bladder in men being pharmacologically treated for benign prostatic hyperplasia: results from the phase 3 randomized controlled COURAGE trial. J Urol. 2024;212(2):256-266. doi:10.1097/JU.0000000000003999
  3. Flomax. Prescribing information. Sanofi-Aventis; 2023.
  4. Edmondson SD, Zhu C, Kar NF, et al. Discovery of vibegron: a potent and selective 3 adrenergic receptor agonist for the treatment of overactive bladder. J Med Chem. 2016;59(2):609-623. doi:10.1021/acs.jmedchem.5b01372

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

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

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