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

Gemtesa (Vibegron) for Overactive Bladder

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

Indications

Gemtesa is FDA-approved for:

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

Dosing and Administration

• Dosage: 75 mg once daily
• Can be taken with or without food
• Swallow tablets whole with a glass of water
• Tablets may be crushed and mixed with a tablespoon of applesauce, then taken immediately with water 1
• No dose adjustment is necessary based on age alone 2

Efficacy

Vibegron has demonstrated significant efficacy in treating OAB symptoms:

• Reduces micturitions (urinations) by an adjusted mean of 1.8 episodes per day (vs. 1.3 for placebo) 3
• Decreases urge incontinence episodes by an adjusted mean of 2.0 episodes per day in incontinent patients (vs. 1.4 for placebo) 3
• Significantly improves urgency episodes and increases voided volume per micturition 3
• Shows efficacy as early as week 2 that is sustained throughout treatment 4

Place in Therapy

According to the American Urological Association (AUA) guidelines:

• Beta-3 agonists like vibegron are recommended as first-line pharmacologic therapy for OAB, along with antimuscarinic medications 5
• Beta-3 agonists are typically preferred over antimuscarinic medications due to their more favorable side effect profile, particularly regarding cognitive effects 5, 2

Warnings and Precautions

• Urinary retention: Monitor for signs and symptoms, particularly in patients with bladder outlet obstruction or those taking muscarinic antagonists 1
• Angioedema: Discontinue immediately if angioedema of the face and/or larynx occurs 1
• Contraindications: Known hypersensitivity to vibegron or any components of Gemtesa 1

Advantages of Vibegron Over Other OAB Medications

1. Favorable cognitive profile: Unlike antimuscarinic medications, beta-3 agonists like vibegron do not carry the same risk of cognitive impairment or dementia 5, 6
2. Minimal drug interactions: Vibegron does not interact with cytochrome P450 enzymes, making it beneficial for patients on multiple medications 6
3. Cardiovascular safety: Vibegron has not shown clinically meaningful effects on blood pressure or heart rate 4

Monitoring and Follow-up

• Assess treatment response after 4-8 weeks to determine efficacy 2
• Monitor for signs of urinary retention, particularly in at-risk patients 1
• Regular follow-up is recommended to reassess symptoms and treatment efficacy 2

Common Side Effects

The most common adverse reactions reported with vibegron include:

• Headache
• Nasopharyngitis
• Diarrhea
• Nausea
• Upper respiratory tract infection 1, 3

Clinical Pearls

• Vibegron may be particularly beneficial for elderly patients due to its minimal cognitive effects compared to antimuscarinic agents 2, 6
• Vibegron has shown efficacy in both mild/moderate and severe OAB symptoms 7
• For patients with inadequate response to monotherapy, combination therapy with an antimuscarinic agent may be considered, though this should be done with caution due to the increased risk of side effects 2