Vibegron

Vibegron is used to treat overactive bladder (a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate, and inability to control urination) in adults. Vibegron is in a class of medications called beta-3 adrenergic agonists. It works by relaxing the bladder muscles to increase bladder capacity.

Vibegron comes as a tablet to take by mouth. It is usually taken once daily with or without food. Take vibegron at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take vibegron exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablet whole with a glass of water. If you are not able to swallow the tablet whole, crush the tablet and mix it with one tablespoon (15 mL) of applesauce. Swallow the mixture immediately with a glass of water.

Vibegron controls the symptoms of overactive bladder, but does not cure the condition. Continue to take vibegron even if you feel well. Do not stop taking vibegron without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking vibegron,

• tell your doctor and pharmacist if you are allergic to vibegron, any other medications, or any of the ingredients in vibegron tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the following: darifenacin (Enablex), digoxin (Lanoxin), oxybutynin (Oxytrol), solifenacin (Vesicare LS), tolterodine (Detrol LA), and trospium. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had trouble emptying your bladder or a weak urine stream, hypertension (high blood pressure), or kidney or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking vibegron, call your doctor.

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

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

• Vibegron may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • headache

  • diarrhea

  • nausea

  • fever, runny or stuffy nose, sore throat, or other signs of infection

• Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

  • difficulty emptying the bladder or weak urine stream

  • fever or painful, urgent, or frequent urination

• Vibegron may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

• If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

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.