What is the recommended treatment and dosage for overactive bladder symptoms using Gemtesa (vibegron)?

Gemtesa (Vibegron) for Overactive Bladder Treatment

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

Indications

• Gemtesa is FDA-approved for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults 1
• It is also indicated for the treatment of OAB symptoms in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH) 1

Dosage and Administration

• The standard dose is 75 mg once daily, which can be taken with or without food 1
• Tablets should be swallowed whole with a glass of water 1
• For patients who have difficulty swallowing, tablets may be crushed and mixed with approximately 15 mL (one tablespoon) of applesauce and taken immediately with a glass of water 1

Mechanism and Benefits

• Vibegron is a beta-3 adrenergic receptor agonist, which represents an alternative to antimuscarinic medications for OAB treatment 2, 3
• As a second-generation beta-3 agonist, vibegron is highly selective and does not interact with cytochrome P450 enzymes, making it advantageous for patients on multiple medications 3
• Clinical trials have demonstrated significant improvements in:
  • Daily micturition frequency 4
  • Urge urinary incontinence episodes 4
  • Urgency episodes 4
  • Total urinary incontinence episodes 4

Safety Profile

• Vibegron has a favorable side effect profile compared to antimuscarinic medications 3, 5
• Common adverse reactions include:
  • Hypertension (8.8%) 4
  • Urinary tract infection (6.6%) 4
  • Headache (5.5%) 4
  • Nasopharyngitis (4.8%) 4
• Unlike antimuscarinic medications, vibegron has a low incidence of dry mouth (1.8% vs 5.2% with tolterodine) 4
• Vibegron does not cause clinically meaningful effects on blood pressure or heart rate, as demonstrated in dedicated ambulatory blood pressure monitoring studies 5, 6

Treatment Algorithm for OAB

1. First-line therapy: Begin with behavioral therapies including bladder training, delayed voiding, pelvic floor muscle training, fluid management, and weight loss 2, 7

2. Second-line therapy: When behavioral approaches are insufficient, proceed to pharmacotherapy:

   • Beta-3 agonists (like vibegron) are typically preferred before antimuscarinic medications due to their favorable side effect profile 2, 5
   • The recommended dose of Gemtesa is 75 mg once daily 1

3. Combination therapy: For patients with inadequate response to monotherapy, consider combining:

   • Behavioral therapy with pharmacotherapy 2
   • Beta-3 agonist with an antimuscarinic medication for potentially additive effects 2, 7

Special Considerations and Warnings

• Urinary retention: Monitor for signs and symptoms of urinary retention, particularly in patients with:

  • Bladder outlet obstruction 1
  • Patients taking muscarinic antagonist medications for OAB 1
  • Discontinue Gemtesa if urinary retention develops 1

• Hypersensitivity: Gemtesa is contraindicated in patients with known hypersensitivity to vibegron or any components of the medication 1

  • Angioedema of the face and/or larynx has been reported with Gemtesa use 1
  • Discontinue immediately if involvement of the tongue, hypopharynx, or larynx occurs 1

• Cognitive concerns: Unlike antimuscarinic medications, beta-3 agonists like vibegron do not have the same risk profile for cognitive impairment or dementia, making them preferable for elderly patients 2, 3

Long-term Efficacy

• Long-term studies have shown sustained efficacy of vibegron over 52 weeks of treatment 4
• After 52 weeks of treatment, 61% of patients experienced ≥75% reduction in urge urinary incontinence episodes, and 40.8% experienced complete resolution of urge incontinence 4

Vibegron represents an effective treatment option for OAB with a favorable side effect profile compared to antimuscarinic medications, particularly for elderly patients or those concerned about cognitive side effects.