What is GEMTESA used for?

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, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH). ( 1.2 ) 1.1 Overactive Bladder in Adults GEMTESA ® is indicated for the treatment of overactive bladder

How does GEMTESA work?

11 DESCRIPTION Vibegron is a selective beta-3 adrenergic agonist.

What pharmaceutical form is GEMTESA available in?

GEMTESA: Tabletki powlekane 75 mg (doustna)

What are the side effects of GEMTESA?

6 ADVERSE REACTIONS The following clinically significant adverse reaction is described elsewhere in the labeling: Urinary retention [see Warnings and Precautions ( 5.1 )] Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sumitomo Pharma America, Inc. at 1-833-876-8268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1

Who should NOT take GEMTESA?

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 )

Does GEMTESA interact with other medications?

7 DRUG INTERACTIONS Concomitant use of GEMTESA increases digoxin maximal concentrations (C max ) and systemic exposure as assessed by area under the concentration-time curve (AUC) [see Clinical Pharmacology ( 12.3 )] . 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 a

Can GEMTESA be used during pregnancy?

8 USE IN SPECIFIC POPULATIONS Pediatric use : Safety and effectiveness in pediatric patients have not been established. ( 8.4 ) End-stage Renal Disease with or without Hemodialysis : Not recommended. ( 8.6 ) Severe Hepatic Impairment : Not recommended. ( 8.7 ) 8.1 Pregnancy Risk Summary There are no available data on GEMTESA use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal studies, no effects on emb

Who manufactures GEMTESA?

Pierre Fabre Medicament (Francja)

What ATC class does GEMTESA belong to?

GEMTESA: ATC G04BD15. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

OTC

GEMTESA

75 mg, Tabletki powlekane

INN: Vibegronum

Data updated: 2026-04-13

Available in:

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Form

Tabletki powlekane

Dosage

75 mg

Route

doustna

Storage

—

About This Product

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