vibegron (Rx)

Brand and Other Names:Gemtesa
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Dosing & Uses

AdultPediatric

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

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Interactions

Interaction Checker

and vibegron

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            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

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            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

            • 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
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            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.

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            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])

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            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

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.