Gemtesa (Vibegron) Dosing for Overactive Bladder
The recommended dose of Gemtesa (vibegron) is 75 mg orally once daily, taken with or without food. 1
Administration Details
- Swallow the tablet whole with a glass of water 1
- Alternative administration method: The tablet may be crushed, mixed with approximately one tablespoon (15 mL) of applesauce, and taken immediately with a glass of water 1
- No dose adjustment is required based on age, renal function, or hepatic function for the standard 75 mg dose 1
Key Clinical Considerations
Efficacy Profile
- Vibegron 75 mg demonstrates significant improvement in urgency episodes, micturition frequency, and urge urinary incontinence episodes compared to placebo, with benefits observed as early as week 2 of treatment 2, 3
- The medication is effective in both OAB-dry and OAB-wet populations, showing significant reductions in urgency episodes and daily micturitions in both subgroups 3
Safety Monitoring
- Monitor for urinary retention, particularly in patients with bladder outlet obstruction or those taking concurrent antimuscarinic medications 1
- Watch for angioedema, which can occur after the first dose or multiple doses and may involve the face, tongue, hypopharynx, or larynx 1
- Vibegron has minimal cardiovascular effects and does not cause clinically meaningful changes in blood pressure or heart rate 2
Advantages Over Antimuscarinics
- Lower incidence of dry mouth compared to tolterodine and other antimuscarinics 4
- No significant drug interactions with cytochrome P450 enzymes, making it safer for patients on polypharmacy 5
- No association with cognitive impairment or dementia risk, unlike antimuscarinic medications 6, 5
Treatment Duration
- Efficacy is sustained long-term, with the EMPOWUR extension study demonstrating continued effectiveness through 52 weeks of treatment 2
Contraindications
- Do not use in patients with known hypersensitivity to vibegron or any component of Gemtesa, as hypersensitivity reactions including angioedema have been reported 1