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

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Contraindicated (0)

              Serious - Use Alternative (0)

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                  Minor (0)

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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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                    Images

                    No images available for this drug.
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                    Patient Handout

                    A Patient Handout is not currently available for this monograph.
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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.

                    Adding plans allows you to:

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                    • Manage and view all your plans together – even plans in different states.
                    • 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.