Dosing & Uses
Dosage Forms & Strengths
tablet
- 75mg
Overactive Bladder
Indicated for overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency
75 mg PO qDay
Dosage Modifications
Renal impairment
- Mild-to-severe (eGFR 15 to <90 mL/min/1.73 m2): No dosage adjustment necessary
- End-stage renal disease (eGFR <15 mL/min/1.73 m2) with or without hemodialysis: Not recommended
Hepatic impairment
- Mild-to-moderate (Child-Pugh A and B): No dosage adjustment necessary
- Severe (Child-Pugh C): Not recommended
Safety and efficacy not established
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (0)
Minor (0)
Adverse Effects
1-10%
- Urinary tract infection (6.6%)
- Headache (4%)
- Bronchitis (2.9%)
- Nasopharyngitis (2.8%)
- Diarrhea (2.2%)
- Nausea (2.2%)
- Upper respiratory tract infection (2%)
- Dry mouth (<2%)
- Constipation (<2%)
- Residual urine volume increased (<2%)
- Urinary retention (<2%)
- Hot flush (<2%)
Postmarketing Reports
Urologic disorders: Urinary retention
Skin and subcutaneous tissue disorders: Pruritus, rash, drug eruption, eczema
Gastrointestinal disorders: Constipation
Warnings
Contraindications
Hypersensitivity reaction to vibegron or any components of product
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
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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
Pregnancy
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
Animal data
- Delayed fetal skeletal ossification was observed in rabbits at ~898-fold clinical exposure, in presence of maternal toxicity
- Developmental toxicity was observed in offspring at ~458-fold clinical exposure, in the presence of maternal toxicity
- No effects on offspring at 89-fold clinical exposure
Lactation
No data available on presence in 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 drug is present in animal milk, it is likely that drug will be present in human milk
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
- Selective human beta-3 adrenergic receptor agonist
- Activation of beta-3 adrenergic receptor increases bladder capacity by relaxing the detrusor smooth muscle during bladder filling
Absorption
Peak plasma time: 1-3 hr
Steady-state reached at 7 days
Distribution
Vd: 6,304 L
Protein bound: ~50%
Blood-to-plasma ratio: 0.9
Metabolism
Metabolism plays a minor role in elimination of vibegron
Predominately metabolized by CYP3A4
Elimination
Half-life: 30.8 hr
Excretion: Feces (~59% [54% unchanged]); urine (~20% [19% unchanged])
Administration
Oral Administration
Swallow tablet whole with water
Tablet may be crushed and mixed with a tablespoon (~15 mL) of applesauce and taken immediately with a glass of water
Storage
Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
Keep out of sight and reach of children
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Formulary
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