Vibegron

What Is Vibegron ?

Vibegron (GEMTESA) is a beta-3 adrenergic agonist.

What are the uses of this medicine?

• This medication is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.

How does this medicine work?

• 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.

Who Should Not Use this medicine ?

This medicine cannot be used in:

• In patients with known hypersensitivity to vibegron or any components of the product

Is this medicine FDA approved?

• It was approved for use in the United States in 2020.

How should this medicine be used?

• The recommended dosage of GEMTESA is one 75 mg tablet orally, once daily with or without food.
• Swallow GEMTESA tablets whole with a glass of water.
• In adults, GEMTESA tablets also may be crushed, mixed with a tablespoon (approximately 15 mL) of applesauce and taken immediately with a glass of water.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing dosage form:

• 75 mg tablets

This medicine is available in fallowing brand namesː GEMTESA

What side effects can this medication cause?

Common possible side effects of this medicine include:

• headache
• urinary tract infection
• nasopharyngitis
• diarrhea
• nausea
• upper respiratory tract infection

What special precautions should I follow?

• Urinary retention has been reported in patients taking GEMTESA.
• Monitor patients for signs and symptoms of urinary retention.
• Discontinue GEMTESA in patients who develop urinary retention.

What to do in case of emergency/overdose?

• There is no experience with inadvertent GEMTESA overdosage.
• In case of suspected overdose, treatment should be symptomatic and supportive.

Can this medicine be used in pregnancy?

• There are no available data on GEMTESA use in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of GEMTESA in pediatric patients have not been established.

What should I know about storage and disposal of this medication?

• Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
• Keep this and all medications out of sight and reach of children.
• Dispose unused medication via a take-back option if available; otherwise follow FDA instructions for disposal in the household trash.

• Dailymed label info on Vibegron
• FDA Vibegron

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