Pronunciation: gem tes’ ah
Generic name: vibegron
Dosage form: tablet 75mg
Drug class: Urinary antispasmodics
What is Gemtesa?
Gemtesa is 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 is used to relieve these symptoms in adults with overactive bladder or men taking medicine for benign prostatic hyperplasia (BPH).
Gemtesa works by relaxing the bladder muscle so the bladder can hold more urine and this may reduce the urgency to use the bathroom and decrease the frequency of urinary leaks.
Gemtesa generic name is vibegron.
Gemtesa is a once-daily tablet that is swallowed whole with water or may be crushed, mixed with a tablespoon (~15 mL) of applesauce and taken immediately with a glass of water. The tablet can be taken with or without food.
Gemtesa FDA approval
Gemtesa’s FDA approval is to treat adults with:
- Overactive bladder symptoms of urge urinary incontinence, urgency, and urinary frequency
- Overactive bladder symptoms of urge urinary incontinence, urgency, and urinary frequency in men taking medicines for benign prostatic hyperplasia (BPH).
How does Gemtesa work?
Gemtesa’s mechanism of action (MOA) is a selective human beta-3 adrenergic receptor agonist (β3-AR agonist). Gemtesa works by binding and activating β3-adrenergic receptor, which relaxes the muscles in the wall of the bladder (detrusor muscle), which increases bladder volume. Gemtesa is from a class of medications called beta-3 agonists.
Gemtesa Clinical trial results
In the 12-week clinical trial called Study 3003 (NCT03492281) used for overactive bladder symptoms, Gemesa patients had:
- 2 fewer daily leakage episodes (compared with 1.4 fewer episodes for placebo)
- 1.8 fewer bathroom visits per day (compared to 1.3 fewer episodes for placebo)
- 2.7 fewer “need to urinate immediately” episodes (compared to 2 fewer episodes for placebo
Gemtesa side effects
Common Gemtesa side effects
The most common Gemtesa side effects for OAB include:
- headache (22%)
- cold symptoms -nasopharyngitis (15%)
- diarrhea (12%)
- nausea (12%)
These common side effects occurred in 2% or more of the Gemtesa patients in the 12-week clinical trial for OAB called Study 3003.
The long-term 52-week study had the same side effects as above and also included urinary tract infection (6.6%) and bronchitis (2.9%).
The most common Gemtesa side effects for OAB with BPH include:
In a 12-week clinical trial (Study 3005) evaluating Gemtesa in males with overactive bladder (OAB) who were also taking medication for benign prostatic hyperplasia (BPH), the most common side effects occurring in more than 2% of patients were:
- Hypertension: 9% (compared to 8.3% with placebo)
- Urinary tract infection: 2.5% (compared to 2.2% with placebo)
Serious Gemtesa 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 .
Warnings
Gemtesa should not be taken if you have hypersensitivity to the active ingredient vibegron or any of the inactive ingredients in this medicine.
Urinary Retention: It is important to monitor for urinary retention, especially in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for OAB, as the risk of urinary retention may be greater. If urinary retention develops, discontinue Gemtesa.
Angioedema: Angioedema of the face and/or larynx has been reported with this medicine.
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.
How should I take Gemtesa?
The normal dose of Gemtesa 75mg 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.
Gemtesa Dosing information
Dosing Information for Gemtesa
- Usual Adult Gemtesa Dose: One Gemtesa 75 mg tablet orally once a day.
- How to take: Take Gemtesa tablet with a glass of water with or without food.
- Crushing Option: 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.
Missed 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.
Overdose
Seek emergency medical attention or call the Poison Help line .
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.
