What is Gemtesa (Vibegron)?

From the Guidelines

Gemtesa (vibegron) is a prescription medication approved for treating overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. The standard dosage is 75 mg taken once daily with or without food. Gemtesa works as a selective beta-3 adrenergic receptor agonist, which means it relaxes the bladder muscle during the filling phase, increasing bladder capacity and reducing OAB symptoms.

Key Points

• Unlike older antimuscarinic medications for OAB, Gemtesa typically causes fewer dry mouth and constipation side effects, making it better tolerated by many patients 1.
• Common side effects may include headache, nasal congestion, diarrhea, nausea, and upper respiratory tract infections.
• Patients with severe kidney problems should use this medication with caution, and it may interact with certain medications that affect liver enzymes.
• Improvement in symptoms is usually noticed within 2-8 weeks of starting treatment.
• Lifestyle modifications such as scheduled voiding, fluid management, and pelvic floor exercises should be continued alongside medication therapy for optimal results.

Considerations

• The American College of Physicians recommends against treatment with systemic pharmacologic therapy for stress UI, but recommends pharmacologic treatment in women with urgency UI if bladder training was unsuccessful 1.
• The AUA/SUFU guideline amendment suggests that patients who experience inadequate symptom control and/or unacceptable adverse drug events with one anti-muscarinic medication may experience better symptom control and/or a more acceptable adverse drug event profile with another anti-muscarinic or with a b3 -adrenoceptor agonist 1.

From the FDA Drug Label

GEMTESA is a prescription medicine used to treat the following symptoms due to a condition called overactive bladder in adults, and in adult males taking medicine for benign prostatic hyperplasia (BPH): urge urinary incontinence: a strong need to urinate with leaking or wetting accidents urgency: the need to urinate right away frequency: urinating often

Gemtesa (Vibegron) is a prescription medicine used to treat symptoms of overactive bladder in adults, including urge urinary incontinence, urgency, and frequency, as well as in adult males taking medicine for benign prostatic hyperplasia (BPH) 2.

• It is a selective beta-3 adrenergic agonist that works by relaxing the detrusor smooth muscle during bladder filling, increasing bladder capacity 2.
• Gemtesa is available in 75 mg tablets for oral administration, containing vibegron and inactive ingredients 2.

From the Research

What is Gemtesa (Vibegron)

• Gemtesa, also known as Vibegron, is a medication used to treat overactive bladder (OAB) symptoms 3, 4, 5, 6, 7
• It is a β3-adrenergic receptor agonist that increases the capacity of the bladder, reducing the number of daily micturitions, nocturia, and urgency episodes 5
• Vibegron is a second-generation β3-adrenergic receptor agonist that is highly selective and does not interact with cytochrome P450 enzymes (CYPs), making it a favorable treatment option 4

Mechanism of Action and Efficacy

• Vibegron works by increasing the capacity of the bladder, reducing the number of daily micturitions, and decreasing urgency episodes 5
• Clinical trials, including the EMPOWUR study, have shown that Vibegron is effective in reducing OAB symptoms, including frequency, urgency, and urge urinary incontinence (UUI) 3, 6, 7
• The medication has been shown to be safe and well-tolerated, with a favorable side effect profile compared to other OAB treatments 4, 6, 7

Clinical Trials and Approval

• Vibegron was approved by the US Food and Drug Administration (FDA) in 2020 for the treatment of OAB 3
• The EMPOWUR study, a phase 3 clinical trial, demonstrated the efficacy and safety of Vibegron in treating OAB symptoms 3, 6, 7
• Additional studies, including the EMPOWUR extension study, have shown that Vibegron is effective and safe for long-term use 7