Gemtesa

Gemtesa (vibegron) is a prescription medicine used to treat overactive bladder (OAB) symptoms of urinary urgency, frequency, and urge incontinence in adults, including men with OAB who are taking medicine for benign prostatic hyperplasia (BPH).

Gemtesa works by relaxing the bladder muscle so the bladder can hold more urine, which may reduce the urgency to use the bathroom and decrease the frequency of urinary leaks or wetting accidents.

Gemtesa's generic name is vibegron.

Gemtesa is a once-daily tablet that is swallowed whole with water or may be crushed, mixed with applesauce, and taken immediately with a glass of water. The tablet can be taken with or without food.

Gemtesa is FDA-approved to treat:

• Overactive bladder symptoms in adults, including symptoms of urinary urgency, frequency, and urinary urge incontinence.
• Overactive bladder symptoms in men taking medicines for benign prostatic hyperplasia (BPH).

Gemtesa's mechanism of action (MOA) is to bind and activate the β3-adrenergic receptor, to relax the muscles in the wall of the bladder (detrusor muscle), which increases bladder volume.

Gemtesa class of medications is beta-3 agonists, or more specifically, it is a selective human beta-3 adrenergic receptor agonist (β3-AR agonist).

In the 12-week clinical trial called Study 3003 (NCT03492281) used for overactive bladder symptoms, Gemtesa 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.

With the Gemtesa coupon, you may pay as little as $0 out-of-pocket for each 90-day supply if you qualify.

The cost for prescription drugs varies depending on your insurance plan and which pharmacy you use. A Gemtesa coupon or Gemtesa Simple Savings Card may help you save money. For more cost information, refer to the Gemtesa Price Guide page, Gemtesa Coupon: Do I qualify and how much can I save? or "Does Gemtesa have a patient assistance program?"

The usual dose of Gemtesa 75mg is one tablet once daily, swallowed whole 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 should not be taken if you have hypersensitivity to the active ingredient vibegron or any of the inactive ingredients in this medicine.

Urinary Retention (inability to empty your bladder): Gemtesa may increase the risk of not being able to empty your bladder, especially if you have bladder outlet obstruction or take other medicines for the treatment of an overactive bladder. Tell your doctor right away if you are unable to empty your bladder, and if urinary retention develops, discontinue Gemtesa.

Angioedema: This medicine may cause an allergic reaction called angioedema with swelling of the lips, face, tongue, or throat, with or without difficulty breathing, and may be life-threatening. Stop using Gemtesa and get emergency medical help right away if you have symptoms of angioedema or trouble breathing.

Gemtesa is not recommended in patients with:

• End-stage renal disease with or without hemodialysis
• Severe hepatic impairment.

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.

You should not take Gemtesa if you are allergic to the active ingredient vibegron or any of the 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
• Kidney disease
• Take medicine containing digoxin

Tell your doctor if you are pregnant or breastfeeding.

Common Gemtesa side effects

The most common Gemtesa side effects include nausea (12%), diarrhea (12%), headache (22%), urinary tract infection (6.6%), or cold symptoms (15%) such as stuffy nose, sneezing, and sore throat, which can affect 2% or more of patients taking this medicine.

Other side effects that occurred were dry mouth, constipation, urinary retention, and hot flush, these side effects occurred in 2% or less of patients.

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 empty your bladder completely.
• 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.

Gemtesa dosing information

Usual Adult Gemtesa Dose: One Gemtesa 75 mg tablet orally once a day.

End-stage renal disease with or without hemodialysis: Not recommended

Severe Hepatic impairment: Not recommended.

Strength available

• Gemtesa 75mg tablet

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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.

Store at 20°C to 25°C (68°F to 77°F).

Manufactured for and Distributed by: Sumitomo Pharma America, Inc., Marlborough, MA 01752.

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.