VIBEGRON

Beta-3 Agonist

Brand names: GEMTESA, Gems

Oral

Mechanism of Action

12.1 Mechanism of Action Vibegron is a selective human beta-3 adrenergic receptor agonist. Activation of the beta-3 adrenergic receptor increases bladder capacity by relaxing the detrusor smooth muscle during bladder filling.

Indications

1 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. ( 1.1 ) overactive bladder (OAB) with symptoms of urge urinary incontinence

urgency

Contraindications

• 4 CONTRAINDICATIONS GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of GEMTESA. Hypersensitivity reactions
• such as angioedema
• have occurred [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.2 )] . Do not use if prior hypersensitivity reaction to vibegron or any components of the product. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Urinary Retention : Monitor for urinary retention, especially in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for OAB, in whom the risk of urinary retention may be greater
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
GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any component of GEMTESA [see Contraindications ( 4 ) and Adverse Reactions ( 6

Known Side Effects

8 documented side effects by frequency

Drug Not Working

>10%

Diarrhea

1-10%

Headache

1-10%

UTI

1-10%

Fatigue

1-10%

Nausea

1-10%

Constipation

0.1-1%

Dizziness

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral