Version May 2024
Overactive bladder: Oral: 75 mg once daily.
Mild to severe impairment (eGFR 15 to <90 mL/minute/1.73 m2): No dosage adjustment necessary.
End-stage kidney disease (eGFR <15 mL/minute/1.73 m2) with or without hemodialysis: Use is not recommended (has not been studied).
Mild to moderate impairment (Child-Pugh class A and B): No dosage adjustment necessary.
Severe impairment (Child-Pugh class C): Use is not recommended (has not been studied).
Refer to adult dosing.
1% to 10%:
Endocrine & metabolic: Hot flash (<2%)
Gastrointestinal: Constipation (<2%), diarrhea (2%), nausea (2%), xerostomia (<2%)
Genitourinary: Increased post-void residual urine volume (<2%), urinary retention (<2%)
Nervous system: Headache (4%)
Respiratory: Nasopharyngitis (3%), upper respiratory tract infection (2%)
Postmarketing:
Dermatologic: Eczema, pruritus, skin rash
Hypersensitivity: Fixed drug eruption
Hypersensitivity to vibegron or any component of the formulation.
Disease-related concerns:
• Bladder flow obstruction: Use with caution in patients with bladder outlet obstruction and in patients using concomitant muscarinic antagonists; may increase the risk of urinary retention. Monitor for signs and symptoms of urinary retention; discontinue use if urinary retention occurs.
• Hepatic impairment: Use is not recommended in patients with severe impairment; has not been studied.
• Renal impairment: Use is not recommended in patients with end-stage kidney disease (eGFR <15 mL/minute/1.73 m2 with or without hemodialysis); has not been studied.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Gemtesa: 75 mg [contains fd&c blue #2 (indigo carm) aluminum lake]
No
Tablets (Gemtesa Oral)
75 mg (per each): $19.45
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Oral: Administer with or without food. Swallow tablets whole with a glass of water. Tablets may be crushed and mixed with a tablespoonful (~15 mL) of applesauce. Swallow applesauce mixture immediately after preparation, followed by a glass of water.
Overactive bladder: Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
Vibegron may be confused with vigabatrin, Vigadrone.
Substrate of CYP3A4 (minor), P-glycoprotein/ABCB1 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Digoxin: Vibegron may increase the serum concentration of Digoxin. Risk C: Monitor therapy
Adverse events were not observed in animal reproduction studies except at the highest doses, which also caused maternal toxicity.
It is not known if vibegron is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Postvoid residual urine volume at baseline and as clinically indicated thereafter (AUA [Lerner 2021]); signs and symptoms of urinary retention.
Vibegron, a selective human beta-3 adrenergic receptor agonist, activates beta-3 adrenergic receptors in the bladder resulting in relaxation of the detrusor smooth muscle during the urine storage phase, thus increasing bladder capacity.
Distribution: Vd: 6,304 L.
Protein binding: ~50%.
Metabolism: Minor metabolism hepatically via CYP3A4.
Half-life elimination: 30.8 hours.
Time to peak: ~1 to 3 hours.
Excretion: Feces: ~59% (54% as unchanged); Urine: 20% (19% as unchanged).
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