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For your male patients with overactive bladder (OAB)

New Indication:
Gemtesa is the first and only treatment for oab in men treated for BENIGN PROSTATIC HYPERPLASIA (BPH)1,2

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More men may be suffering from OAB than you think3,5

As many as

3out of4

men with BPH also have OAB symptoms

Many men still experience OAB symptoms while on treatment for BPH3-5

patient carl image

Meet Carl*

*Not an actual patient.

Questions whether his BPH treatment is enough to relieve his OAB symptoms

Carl was tired of interruptions from his urinary symptoms. When urgency continued despite BPH treatment, he knew he needed to talk to his doctor about how he was feeling.

Do you see patients like Carl in your practice? GEMTESA may help.

Proven safety profile:

Adverse Reactions, Exceeding Placebo Rate, Reported in ≥2% of Patients Treated with GEMTESA 75 mg for up to 12 Weeks1

Adverse event table

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

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

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The ONLY β3 treatment with NO blood pressure warning in its label1,2,6,7

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No CYP2D6 drug interactions1

Digoxin drug interaction was identified with GEMTESA. Measure serum digoxin concentrations before initiating GEMTESA. Monitor serum digoxin concentrations to titrate digoxin dose to desired clinical effect. Continue monitoring digoxin concentrations upon discontinuation of GEMTESA and adjust digoxin dose as needed.1

Proven reduction data for all key symptoms of OAB in its label1,8,9:

icon urgency

Urgency1,6

icon frequency

Frequency1,10

icon urge incontinence

Urge urinary incontinence1,6

Three areas to cover when initially evaluating a patient with symptoms suggestive of OAB11:

1

2

3

Obtain

a medical history with comprehensive assessment of bladder symptoms,

Conduct

a physical examination, and

Perform

a urinalysis to exclude microhematuria and infection

Diagnose OAB in men with BPH

Access the OAB screener Now
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Resources are available to support your patients with treatment

Learn About Patient Support

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; 2024.
  2. Myrbetriq. Prescribing information. Astellas Pharma Inc; 2012. Revised 04/2021.
  3. Burnett AL, Walker DR, Feng Q, et al. Undertreatment of overactive bladder among men with lower urinary tract symptoms in the United States: a retrospective observational study. Neurourol Urodyn. 2020;39(5):1378-1386. doi:10.1002/nau.24348
  4. Chapple C. Systematic review of therapy for men with overactive bladder. Can Urol Assoc J. 2011;5(5)(suppl 2):S143-S145. doi:10.5489/cuaj.11186 
  5. Gomelsky A, Dmochowski RR. Overactive bladder in males. Ther Adv Urol. 2009;1(4):209-221. doi:10.1177/1756287209350383
  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
  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. 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
  9. Willis-Gray MG, Dieter AA, Geller EJ. Evaluation and management of overactive bladder: strategies for optimizing care. Res Rep Urol. 2016;8:113-122. doi:10.2147/RRU.S93636
  10. Data on file. Sumitomo Pharma America, Inc.
  11. Al Hussein Alawamlh O, Al Hussein Al Awamlh B, Lee U, Lee RK. Overactive bladder in women: an update for primary care physicians. Curr Bladder Dysfunct Rep. 2020;15:44-52. doi.org/10.1007/s11884-020-00574-4

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

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