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SEE WHO MIGHT BENEFIT FROM GEMTESA

Effective OAB* treatment for a broad range of patients1-6

Men and women

Patients previously treated for OAB

Patients who are OAB treatment naïve

Men with OAB who are being pharmacologically treated for BPH

Older adults (65+)

No overall differences in safety or effectiveness of GEMTESA have been observed between patients aged 65+ and younger adult patients

Patients taking CYP2D6-metabolized medications

Patients currently taking medications metabolized through the CYP2D6 pathway for comorbidities (common comorbidities in patients with OAB include hypertension and depression)

Patients with hypertension

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)

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

* The 3 key symptoms of OAB include urgency, frequency, and UUI.6

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.1

BP=blood pressure; BPH=benign prostatic hyperplasia; OAB=overactive bladder, UUI=urge urinary incontinence.

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. 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
  3. 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.
  4. Data on file. Sumitomo Pharma America, Inc.
  5. Crestor. Prescribing information. AstraZeneca; 2024.
  6. Ganz ML, Liu J, Zou KH, Bhagnani T, Luo X. Real-world characteristics of elderly patients with overactive bladder in the United States. Curr Med Res Opin. 2016;32(12):1997-2005. doi:10.1080/03007995.2016.1226167
  7. 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

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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