Vibegron
Pronunciation: vib-e-gron
Generic name: vibegron
Brand name: Gemtesa
Dosage form: tablet 75mg
Drug class: Urinary antispasmodics
What is vibegron?
Vibegron is used to treat overactive bladder (OAB) symptoms, such as:
- Frequent urination
- Sudden urges to urinate
- Urinary incontinence (leakage).
This prescription medicine is also approved for men who are taking medicines for benign prostatic hyperplasia (BPH) to help manage their bladder symptoms. Vibegron is a once-daily tablet that can be taken with or without food.
Vibegron is sold under the brand name Gemtesa which first gained FDA approval on December 23, 2020. There is no vibegron generic.
How does vibegron work?
Vibegron is a beta-3 agonist that works by:
- Activating special receptors in your bladder wall
- Relaxing the bladder muscle (detrusor muscle)
- Increasing how much urine your bladder can hold
- Reducing urgent bathroom needs and accidents.
Vibegron side effects
The most common side effects of vibegron are:
- nausea
- diarrhea
- headache
- urinary tract infections
- cold symptoms (stuffy nose, sneezing, sore throat).
Other, less common side effects include:
- dry mouth
- constipation
- difficulty urinating
- hot flashes.
Important Safety Warnings
Seek immediate medical attention if you experience:
- Signs of allergic reaction (hives, breathing difficulties, facial swelling)
- Urinary retention (inability to empty bladder)
- Pain or burning during urination
- Face or throat swelling (angioedema.
This is not a complete list of side effects and others may occur. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or Sumitomo Pharma America at 1-833-876-8268.
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Cost and Savings Options
The Gemtesa Simple Savings Card may help reduce costs:
- Some patients may pay as little as $0 for a 90-day supply
- Available for those with commercial insurance
- Not valid for Medicare/Medicaid patients
- Various patient assistance programs are available.
See Gemtesa Coupons, Copay Cards, Prices & Patient Assistance for more information about the cost of vibegron if you do not have insurance.
Before taking this medicine
You should not take vibegron if you are allergic to vibegron, Gemtesa, or any inactive ingredients in the tablets (see below for a list of ingredients).
To make sure vibegron is safe for you, tell your healthcare provider if you have ever had:
- Bladder emptying problems
- Weak urine stream
- Liver disease
- Kidney disease.
Tell your doctor if you are pregnant or breastfeeding or have any pregnancy or breastfeeding plans.
How should I take vibegron?
Your healthcare provider will tell you how much vibegron to take. Follow their instructions and refer to the Gemtesa (vibegron) Package Insert.
- Take 1 vibegron 75 mg tablet a day.
- Can be taken with or without food.
- Take with a full glass of water.
- If needed, tablets can be crushed and mixed with applesauce.
Dosing information
Usual Adult Vibegron Dose for OAB or BPH: Vibegron 75 mg once a day.
What happens if I miss a dose?
Take vibegron as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking vibegron?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What other drugs will affect vibegron?
Tell your doctor about all your other medicines, especially:
- digoxin or digitalis.
This list is not complete. Other drugs may interact with vibegron, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here. See the vibegron (Gemtesa) prescribing information for more interactions.
Ingredients
Vibegron is only available under the brand name Gemtesa.
Active ingredient: vibegron.
Inactive ingredients: Croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, mannitol, and microcrystalline cellulose.
The light green film coating contains FD&C Blue No. 2 - aluminum lake, hypromellose, iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin.
Vibegron is available in 75 mg tablets.
Storage
Store vibegron at room temperature around 20°C to 25°C (68°F to 77°F).
Who makes vibegron
Vibegron (Gemtesa) is manufactured by Urovant Sciences, Inc., which operates as part of Sumitomo Pharma America. The company was founded in 2016 and is headquartered in Irvine, California.
Popular FAQ
Does Gemtesa (vibegron) cause constipation?
Constipation is listed as a side effect of Gemtesa, but it is uncommon, occurring in less than 2% (2 out of every 100) people who take Gemtesa.
How long does it take for Gemtesa (vibegron) to work?
Gemtesa (vibegron) starts working almost immediately – within a few days of first taking it, with noticeable improvements in urinary urgency, frequency, and incontinence noted in clinical trials at 2 weeks which were reported as significant by 12 weeks.
After 12 weeks, people taking Gemtesa had 2 fewer daily leakage episodes compared to 1 fewer episode in those taking placebo, 2 fewer bathroom visits (versus 1 fewer with placebo), and 3 fewer “urge to go” visits a day compared to 2 fewer with placebo. Continue reading
How does Gemtesa (vibegron) work?
Gemtesa (vibegron) works by relaxing the detrusor muscle of the bladder – this is smooth muscle found in the wall of the bladder – and it does this by activating beta-3 adrenergic receptors located in the detrusor muscle. By activating these receptors, the muscle in the bladder wall relaxes. This allows the bladder to hold more urine, which can relieve symptoms of overactive bladder such as needing to pass urine immediately or frequently (urinary urgency and frequency) and reduce urine leakage (urinary incontinence). Continue reading
Does Gemtesa (vibegron) cause weight gain?
Weight gain is not listed as a side effect of Gemtesa (vibegron) in the product information and there does not seem to be any anecdotal reports of weight gain from blog sites or Gemtesa reviews. Gemtesa does not cause weight gain. Continue reading
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- Drug class: urinary antispasmodics
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.