Vibegron

Vibegron is a  prescription medication used for treating the symptoms of overactive bladder. 

• Vibegron is available under the following different brand names: Gemtesa

Common side effects of Vibegron include:

• headache,
• urinary tract infection (UTI),
• runny or stuffy nose,
• diarrhea,
• nausea, and
• upper respiratory tract infection.

Serious side effects of Vibegron include:

• urinary retention

Rare side effects of Vibegron include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 75 mg

Overactive Bladder

Adult dosage

• 75 mg orally everyday target dose of 20 mg every day based on eGFR and serum potassium thresholds

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Vibegron has severe interactions with no other drugs.
• Vibegron has serious interactions with no other drugs.
• Vibegron has moderate interactions with no other drugs.
• Vibegron has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity reaction to vibegron or any components of product

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Vibegron?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Vibegron?”

Cautions

Urinary retention

• Urinary retention reported
• Risk increased in patients with bladder outlet obstruction and patients taking muscarinic antagonists medications; closely monitor patients during treatment
• Monitor for signs and symptoms of urinary retention
• Discontinue in patients who develop urinary retention

Drug interaction overview

• Digoxin
  • Vibegron increases digoxin maximal concentrations and systemic exposure
  • Monitor serum digoxin concentrations before initiating, during therapy, and for dose titration
  • Continue monitoring digoxin concentrations after discontinuing vibegron and adjust digoxin dose as needed

Pregnancy & Lactation

• No data available on use in pregnant females to evaluate for drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes

Lactation

• No data is available on the presence of human milk, effects on breastfed infants, or effects on milk production
• When a single oral dose of radiolabeled vibegron was administered to postnatal nursing rats, radioactivity was observed in milk
• If the drug is present in animal milk, the drug will likely be present in human milk