Drug Guide

Generic Name

Vibegron

Brand Names Gemtesa

Classification

Therapeutic: Urinary Bladder Modulator

Pharmacological: Beta-3 adrenergic receptor agonist

FDA Approved Indications

  • Overactive Bladder (OAB) with symptoms of urinary frequency, urgency, and urge incontinence

Mechanism of Action

Vibegron selectively stimulates beta-3 adrenergic receptors in the detrusor muscle of the bladder, leading to relaxation of the bladder muscle and increased storage capacity, thereby reducing symptoms of overactive bladder.

Dosage and Administration

Adult: 75 mg once daily, with or without food

Pediatric: Not approved for pediatric use

Geriatric: No specific dose adjustment needed but consider renal and hepatic function

Renal Impairment: No dose adjustment recommended in mild to moderate impairment; limited data in severe impairment

Hepatic Impairment: No specific dose adjustment necessary

Pharmacokinetics

Absorption: Rapid oral absorption, peak plasma levels in 1-2 hours

Distribution: Extensively distributed; plasma protein binding approximately 70%

Metabolism: Primarily metabolized via CYP3A4 enzyme

Excretion: Primarily excreted in feces (approximately 80%), with renal excretion of unchanged drug (~20%)

Half Life: about 48 hours

Contraindications

  • Hypersensitivity to vibegron or any component of the formulation

Precautions

  • Use with caution in patients with severe renal impairment or hepatic impairment; monitor for urinary retention or other urinary symptoms

Adverse Reactions - Common

  • Headache (Common)
  • Upper respiratory tract infection (Common)
  • Urinary tract infection (Common)

Adverse Reactions - Serious

  • Serious allergic reactions, including angioedema (Rare)
  • Elevated blood pressure (Rare)

Drug-Drug Interactions

  • CYP3A4 inhibitors may increase vibegron levels

Drug-Food Interactions

  • No significant food interactions reported

Drug-Herb Interactions

  • No significant herb interactions reported

Nursing Implications

Assessment: Monitor renal and hepatic function periodically; assess for urinary retention or worsening urinary symptoms.

Diagnoses:

  • Risk for urinary retention

Implementation: Administer orally once daily; instruct patients to take with or without food.

Evaluation: Evaluate efficacy based on reduction of symptoms; monitor for side effects.

Patient/Family Teaching

  • Take medication exactly as prescribed.
  • Report any signs of allergic reactions, urinary retention, or adverse effects.
  • Maintain adequate fluid intake.
  • Do not discontinue medication abruptly without consulting healthcare provider.

Special Considerations

Black Box Warnings:

  • None currently issued

Genetic Factors: Limited data available on pharmacogenomics affecting response

Lab Test Interference: No known interference

Overdose Management

Signs/Symptoms: Nausea, dizziness, hypertension, or urinary retention

Treatment: Supportive care; monitor vital signs; standard procedures for overdose management as indicated.

Storage and Handling

Storage: Store at room temperature, 20-25°C (68-77°F), away from moisture and light

Stability: Stable under recommended storage conditions for at least 2 years

This guide is for educational purposes only and is not intended for clinical use.