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.

• 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.

The recommended dose of vibegron is one 75 mg tablet once daily.

See full prescribing information for more information about vibegron dosing.

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.

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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

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.

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.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.