What is the recommended treatment and dosage for Gemtesa (vibegron) in patients with overactive bladder?

Gemtesa (Vibegron) Treatment for Overactive Bladder

The recommended treatment for overactive bladder with Gemtesa (vibegron) is one 75 mg tablet taken orally once daily, with or without food. 1

Indications

Gemtesa (vibegron) is FDA-approved for:

• Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults 1
• Treatment of OAB symptoms in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH) 1

Dosage and Administration

• Dose: 75 mg once daily 1
• Administration:
  • Take with or without food
  • Swallow tablets whole with a glass of water
  • Tablets may be crushed and mixed with a tablespoon of applesauce and taken immediately with water 1

Mechanism and Benefits

Vibegron is a beta-3 adrenergic receptor agonist that:

• Improves bladder storage function by relaxing the detrusor muscle during the filling phase 2
• Offers significant advantages over antimuscarinic medications, particularly regarding cognitive side effects 3
• Is preferred as a first-line pharmacologic treatment due to lower risk of cognitive side effects, especially in older adults 3

Efficacy

Clinical trials have demonstrated that vibegron 75 mg significantly improves OAB symptoms compared to placebo:

• Reduces average daily number of micturitions by 1.8 episodes (vs. 1.3 for placebo) 1
• Decreases urge urinary incontinence episodes by 2.0 per day (vs. 1.4 for placebo) 1
• Reduces urgency episodes by 2.7 per day (vs. 2.0 for placebo) 1
• Increases average voided volume by 23 mL (vs. 2 mL for placebo) 1

Place in Treatment Algorithm

1. First-line: Behavioral therapy (bladder training, pelvic floor exercises, fluid management) 2, 3
2. First-line pharmacotherapy: Beta-3 adrenergic agonists like vibegron are preferred over antimuscarinic medications 2, 3
3. Second-line: Combination therapy with behavioral interventions and pharmacotherapy 2
4. Third-line: For inadequate response, consider minimally invasive procedures (sacral neuromodulation, tibial nerve stimulation, intradetrusor botulinum toxin) 2

Contraindications

Gemtesa is contraindicated in patients with:

• Known hypersensitivity to vibegron or any components of the medication 1

Warnings and Precautions

• Urinary retention: Monitor for signs and symptoms, particularly in patients with bladder outlet obstruction or those taking antimuscarinic medications 1
• Angioedema: Discontinue immediately if angioedema of face or larynx occurs 1

Common Side Effects

Vibegron has a favorable side effect profile compared to antimuscarinic medications:

• Lower incidence of dry mouth compared to antimuscarinic medications 3
• No significant increase in hypertension compared to placebo 1, 4
• Well-tolerated in long-term studies 5

Special Populations

• Elderly: Efficacy and safety maintained in patients ≥65 years 6
• Drug interactions: Minimal drug interactions, beneficial for patients with polypharmacy 6

Monitoring

• Assess treatment response by tracking frequency of urination, urgency episodes, and incontinence episodes 3
• Monitor for signs of urinary retention, particularly in at-risk patients 1
• Obtain post-void residual if symptoms worsen or don't improve adequately 2

Clinical Pearls

• Beta-3 agonists like vibegron are typically preferred over antimuscarinic medications due to lower risk of cognitive effects 2, 3
• If response to vibegron is inadequate, consider combination therapy with behavioral interventions before moving to more invasive options 2
• Discontinue oral medications if patient has an appropriate response to a minimally invasive procedure, but restart if efficacy is not maintained 2
• Avoid recommending unproven supplements, nutraceuticals, or herbal remedies for OAB treatment 2