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HOW DOES GEMTESA WORK?

GEMTESA (vibegron) is not an anticholinergic treatment—it works differently by selectively targeting beta-3 adrenergic receptors¹

Bladder relaxation is predominantly mediated by beta-3 adrenergic receptors^1,2

M₃ (muscarinic) receptor
Activating the muscarinic receptors contracts the bladder detrusor muscle to mediate bladder emptying²

Beta-3 receptor
Activating the beta-3 adrenergic receptors relaxes the bladder detrusor muscle to increase capacity^1-3

Diagram of a bladder. GEMTESA® activates the beta-3 adrenergic receptor, relaxing the bladder detrusor muscle.

GEMTESA is a selective beta-3 adrenergic agonist^1,4

IN VITRO RECEPTOR BINDING ASSAY DATA*

Beta-adrenergic receptor subtype

GEMTESA (% activity)^†

Beta-1

Beta-2

2.0

Beta-3

104.0

*Clinical relevance of this in vitro receptor binding assay data is unknown.

^†At 10 µM (exceeds mean human C_max values of GEMTESA by ~30x).^1,4,5

C_max=maximum serum concentration.

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

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. Yamaguchi O, Chapple CR. β₃-adrenoceptors in urinary bladder. Neurourol Urodyn. 2007;26(6):752-756. doi:10.1002/nau.20420 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. Brucker BM, King J, Mudd PN, McHale K. Selectivity and maximum response of vibegron and mirabegron for β₃-adrenergic receptors. Curr Ther Res Clin Exp. 2022;96:100674. doi:10.1016/j.curtheres.2022.100674 5. Data on file. Sumitomo Pharma America, Inc.

HOW DOES GEMTESA WORK?

GEMTESA (vibegron) is not an anticholinergic treatment—it works differently by selectively targeting beta-3 adrenergic receptors1

GEMTESA is a selective beta-3 adrenergic agonist1,4

GEMTESA (vibegron) is not an anticholinergic treatment—it works differently by selectively targeting beta-3 adrenergic receptors¹

GEMTESA is a selective beta-3 adrenergic agonist^1,4