From the FDA Drug Label
GEMTESA is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. The recommended dosage of GEMTESA is one 75 mg tablet orally, once daily with or without food. GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of GEMTESA. Urinary retention has been reported in patients taking GEMTESA. Angioedema of the face and/or larynx has been reported with GEMTESA. Adverse reactions that were reported at an incidence greater than placebo and in ≥2% of patients treated with GEMTESA include: * Headache * Nasopharyngitis * Diarrhea * Nausea * Upper respiratory tract infection
The pros of Gemtesa (vibegron) are:
- Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults
- Convenient once-daily oral dosage
The cons of Gemtesa (vibegron) are:
- Urinary retention
- Angioedema of the face and/or larynx
- Hypersensitivity reactions
- Common adverse reactions such as headache, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection
- Contraindicated in patients with known hypersensitivity to vibegron or any components of GEMTESA 1, 1, 1
From the Research
Pros of Gemtesa (Vibegron)
- Effective in reducing urgency urinary incontinence (UUI) episodes and daily micturition number 2, 3, 4, 5
- Has a favorable side effect profile compared to other treatments for overactive bladder (OAB) 2, 3, 4, 5
- Highly selective and does not interact with cytochrome P450 enzymes (CYPs) 2
- Improves quality of life and patient satisfaction 3, 4, 5
- Can be effective for patients with wet OAB, with a significant reduction in urge urinary incontinence episodes 4, 6
Cons of Gemtesa (Vibegron)
- May cause adverse events such as dry mouth, residual urine volume increased, constipation, and cystitis 3
- May cause hypertension, urinary tract infection, and nasopharyngitis 4, 6
- Limited long-term data available, although available data suggests long-term safety and efficacy 3, 4
- May not be as effective for all patients, with some patients requiring a higher dose to achieve desired efficacy 3
- May have interactions with other medications, although the risk is considered low 2
Comparison to Other Treatments
- Vibegron has been compared to mirabegron and tolterodine in several studies, with results suggesting that vibegron may have a more favorable efficacy and safety profile 4, 6, 5
- Vibegron has been shown to be effective in patients who have failed other treatments for OAB, including antimuscarinics and beta-3 adrenergic receptor agonists 2