Gemtesa
Pronunciation: gem tes' ah
Generic name: vibegron
Dosage form: tablet 75mg
Drug class: Urinary antispasmodics
What is Gemtesa?
Gemtesa tablets are used to treat overactive bladder (OAB) symptoms including urinary urgency, urinary frequency, and urge incontinence, which is when you have a strong need to urinate with leaking or wetting accidents. Gemtesa works by relaxing the bladder muscle so it can hold more urine, this may also reduce the urgent need to use the bathroom and may reduce the number of urinary leakages you have.
Gemtesa is a once-daily tablet that can be taken with or without food.
Gemtesa (vibegron) received FDA approval on December 23, 2020, to treat adults with overactive bladder symptoms of urge urinary incontinence, urgency, and urinary frequency. It is from a group of medications called beta-3 agonists.
Gemtesa side effects
The most common Gemtesa side effects include nausea, diarrhea, headache, urinary tract infection, or cold symptoms such as stuffy nose, sneezing, and sore throat, which can affect 2% or more of patients taking this medicine.
Serious side effects
Get emergency medical help if you have signs of an allergic reaction to Gemtesa with symptoms of hives; difficulty breathing; and swelling of your face, lips, tongue, or throat.
Call your doctor at once if:
- you are unable to completely empty your bladder; or
- you have pain or burning when you urinate.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Warnings
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
Before taking this medicine
You should not take Gemtesa if you are allergic to the active ingredient vibegron, or any inactive ingredients.
To make sure Gemtesa is safe for you, tell your doctor if you have ever had:
- trouble emptying your bladder;
- a weak stream of urine;
- liver disease; or
- kidney disease.
Tell your doctor if you are pregnant or breastfeeding.
Gemtesa is not approved for use by anyone younger than 18 years old.
How should I take Gemtesa?
Gemtesa instructions:
The normal dose of Gemtesa is one tablet, taken by mouth, once daily. Take this medicine with a full glass of water. You may take Gemtesa with or without food.
If you cannot swallow a tablet whole, you may crush the tablet and mix it with 1 tablespoon of applesauce. Swallow the mixture right away with a glass of water. Do not save the mixture for later use.
Use Gemtesa exactly as prescribed by your doctor. Follow all directions on your prescription label and use the medicines exactly as directed. Follow all directions on your prescription label and read all medication guides or instruction sheets.
Dosing information
Usual Adult Gemtesa Dose is one Gemtesa 75 mg tablet orally once a day.
Use: For the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults
Available as: Gemtesa 75mg tablets
What happens if I miss a dose?
Take the medicine 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 Gemtesa?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What other drugs will affect Gemtesa?
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.
Ingredients
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.
Storage
Store at 20°C to 25°C (68°F to 77°F).
Company
Manufactured for and Distributed by: Urovant Sciences, Inc. Irvine, CA 92617.
Popular FAQ
You can reach the Gemtesa patient assistance program (Gemtesa Simple Savings Program) at 1-833-876 -8268 or online at the Gemtesa website. If you are eligible for a copay card, you may pay as little as $0 for a 90-day supply of medicine if you have commercial insurance and your benefit plan covers Gemtesa. Government plans like Medicare and Medicaid are not eligible. Other savings options for patients without insurance may be available.
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 can be taken any time of the day with or without food, or as directed by your doctor. Take it at about the same time each day so you don’t forget your dose. Swallow Gemtesa tablets whole with a glass of water. You can also crush the tablet, mix it into a tablespoon (15 mL) of applesauce and take it right away with a glass of water if you have trouble swallowing the pill.
Cognitive decline, which may include dementia, memory loss and confusion, is not a known side effect for Gemtesa (vibegron) or the beta-3 agonist class as a whole. In addition, a study found the use of anticholinergic medications among patients with overactive bladder (OAB) was associated with an increased risk of new-onset dementia compared to beta-3 agonist users. Continue reading
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
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
