Vibegron (vye-BEG-ron)

Treats symptoms of an overactive bladder.

Brand Name(s):

Gemtesa

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the tablet whole with a glass of water. You may also crush the tablet and mix it with a tablespoon (about 15 milliliters) of applesauce. Swallow the mixture right away with a glass of water.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how vibegron works. Tell your doctor if you are using digoxin or any other medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, or bladder blockage (trouble urinating or a weak urine stream).
• This medicine may cause urinary retention (trouble passing urine or not fully emptying the bladder), especially when used together with another medicine.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bladder pain, bloody or cloudy urine
• Decrease in how much or how often you urinate, lower back or side pain, difficult or painful urination

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, nausea
• Fever, runny or stuffy nose, sore throat
• Headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088