Vibegron: Uses, Dosage, Side Effects and More

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Hong Kong prescribing information.

Generic Medicine Info

Indications and Dosage

Oral
Overactive bladder

Adult: For treatment of cases with symptoms of urge urinary incontinence, urinary urgency, and urinary frequency: 75 mg once daily. Dosage recommendations may vary among countries and between individual products (refer to specific product guidelines).

Renal Impairment

eGFR (mL/min/1.73 m²)	Dosage
<15 (ESRD with or without haemodialysis)	Not recommended.

Hepatic Impairment

Severe (Child-Pugh class C): Not recommended.

Administration

Vibegron May be taken with or without food. Swallow the tab whole with a glass of water. Alternatively, tab may be crushed and mixed with a tablespoonful (approx 15 mL) of soft food (e.g. applesauce).

Contraindications

Hypersensitivity.

Special Precautions

Patient with bladder outlet obstruction. ESRD (eGFR <15 mL/min/1.73 m² with or without haemodialysis) and severe hepatic impairment. Pregnancy and lactation. Concomitant use with muscarinic antagonists.

Adverse Reactions

Significant: Urinary retention.
Gastrointestinal disorders: Diarrhoea, nausea, dry mouth, constipation.
Investigations: Increased residual urine volume.
Nervous system disorders: Headache.
Renal and urinary disorders: UTI.
Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, URTI.
Skin and subcutaneous tissue disorders: Rash.
Vascular disorders: Hot flush, hypertension.
Potentially Fatal: Angioedema of the face and/or larynx.

Pregnancy Category (US FDA)

PO: Z (Toxicities were reported in some animal studies at exposures much higher than clinical exposure at recommended human dose. Vibegron use during pregnancy is generally not recommended.)

Monitoring Parameters

Monitor post-void residual urine volume at baseline and as clinically indicated during therapy. Assess for signs and symptoms of urinary retention.

Overdosage

Symptoms: Gastrointestinal disorders, headache and dyspnoea.

Management: Symptomatic and supportive treatment.

Drug Interactions

Increased risk of urinary retention with muscarinic antagonists. May increase the serum concentration of digoxin.

Action

Description:
Overview: Vibegron is a selective human β₃-adrenergic receptor agonist.
Mechanism of Action: Vibegron activates β₃-adrenergic receptors in the bladder leading to relaxation of the detrusor smooth muscle during bladder filling, thereby increasing bladder capacity.
Pharmacodynamics: Exposure-response relationship and the time course of pharmacodynamic response are not fully characterised. In vitro studies have shown that vibegron inhibited contraction in a concentration-dependent manner in bladder tissues induced by electrical stimulation. Vibegron does not prolong the QT interval to any clinically relevant extent.
Pharmacokinetics:
Absorption: Time to peak plasma concentration: Approx 1-3 hours.
Distribution: Volume of distribution: 6,304 L. Plasma protein binding: Approx 50%.
Metabolism: Undergoes minor metabolism in the liver by CYP3A4.
Excretion: Via faeces (approx 59%; 54% as unchanged drug); urine (20%; 19% as unchanged drug). Elimination half-life: 30.8 hours.

Chemical Structure

Storage

Store below 30°C.

MIMS Class

Drugs for Bladder & Prostate Disorders

ATC Classification

G04BD15 - vibegron ; Belongs to the class of urinary antispasmodics.

References

Beova 50 mg Film Coated Tablets (Eisai [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 29/09/2025.

Brayfield A, Cadart C (eds). Vibegron. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 29/09/2025.

Gemtesa Tablet, Film Coated (Sumitomo Pharma America, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 29/09/2025.

Joint Formulary Committee. Vibegron. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 29/09/2025.

Obgemsa 75 mg Film-coated Tablets (Pierre Fabre Limited). MHRA. https://products.mhra.gov.uk. Accessed 29/09/2025.

Vibegron. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 29/09/2025.

Vibegron. UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 29/09/2025.

Vibegron. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 29/09/2025.

Disclaimer: This information is independently developed by MIMS based on Vibegron from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2025 MIMS. All rights reserved. Powered by MIMS.com