Vibegron
Generic name: vibegron
Brand name: Gemtesa
Dosage form: oral tablet
Drug class: Urinary antispasmodics
What is vibegron?
Vibegron is a type of drug called a beta-3 agonist. It is used to treat overactive bladder. Overactive bladder is a condition which causes a frequent and sudden urge to urinate that is hard to control.
Vibegron works by activating beta-3 adrenergic receptors in the bladder. This relaxes the main muscle in the bladder wall - the detrusor smooth muscle - while the bladder is filling. Relaxation of the detrusor smooth muscle allows you to hold more urine in your bladder, which helps to treat the symptoms of overactive bladder
Vibegron was approved by the US Food and Drug Administration (FDA) in December 2020 and launched under the brand name Gemtesa the following year.
What is vibegron used for?
Vibegron is a prescription medicine for adults that is used to treat the following symptoms of overactive bladder:
- urge urinary incontinence: a strong need to urinate with leaking or wetting accidents
- urgency: the need to urinate right away
- frequency: urinating often
It is not known if vibegron is safe and effective in children.
Who should not take vibegron?
Do not take vibegron if you are allergic to vibegron or any of the ingredients in this medication. See below for a complete list of ingredients.
Related/similar drugs
Botox, estradiol, oxybutynin, Gemtesa, solifenacin
What should I tell my doctor before taking vibegron?
Before you take vibegron, tell your doctor about all of your medical conditions, including if you:
- have liver problems.
- have kidney problems.
- have trouble emptying your bladder or you have a weak urine stream.
How should I take vibegron?
- Take vibegron exactly as your doctor tells you to take it.
- Take 1 vibegron tablet, by mouth, 1 time a day with or without food.
- Swallow vibegron tablets whole with a glass of water.
- You may also crush vibegron tablets, mix with 1 tablespoon (about 15 mL) of applesauce, and take right away with a glass of water.
Dosing information
The recommended dose of vibegron is one 75 mg tablet once daily.
See full prescribing information for more information about vibegron dosing.
What are the side effects of vibegron?
Vibegron may cause serious side effects including:
- inability to empty your bladder (urinary retention). Vibegron may increase your chances of not being able to empty your bladder, especially if you have bladder outlet obstruction or take other medicines for treatment of overactive bladder. Tell your doctor right away if you are unable to empty your bladder.
The most common side effects of vibegron include:
- urinary tract infection
- headache
- nasal congestion, sore throat or runny nose
- diarrhea
- nausea
- upper respiratory tract infection
These are not all the possible side effects of vibegron. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Interactions
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Especially tell your doctor if you take medicines that contain digoxin. Your blood levels of digoxin should be monitored before, during and after treatment with vibegron because treatment with vibegron may affect the dose of digoxin you should take.
Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
Pregnancy and breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if vibegron will harm your unborn baby.
Tell your doctor if your are breastfeeding or plan to breastfeed. It is not known if vibegron passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take vibegron.
Storage
- Store vibegron at room temperature between 68°F to 77°F (20°C to 25°C).
- Safely throw away medicine that is no longer needed in your household trash.
- You may also dispose of the unused medicine through a take-back option, if available. See WWW.FDA.GOV/DRUGDISPOSAL for more information.
Keep vibegron and all medicines out of the reach of children.
What are the ingredients in vibegron?
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 manufactured and distributed under the brand name Gemtesa by Urovent Sciences, Inc, Irvine, CA 92617.
Popular FAQ
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.
It is possible that beta-3 agonists, such as Gemtesa, could promote weight loss. A small study that investigated mirabegron, another beta-3 agonists used for OAB, found that it also activated beta-3 receptors located in brown fat (adipose) tissue which boosted the participants' ability to burn energy, increasing the number of calories they burned. But this was a preliminary study and larger trials are needed.
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.
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
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
References
- National Library of Medicine Gemtesa Product Label
- Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd PN Jr. International Phase III, Randomized, Double-Blind, Placebo and Active Controlled Study to Evaluate the Safety and Efficacy of Vibegron in Patients with Symptoms of Overactive Bladder: EMPOWUR. J Urol. 2020;204(2):316-324. doi:10.1097/JU.0000000000000807.
More about vibegron
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- Drug class: urinary antispasmodics
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