Gemtesa (vibegron) dosing, indications, interactions, adverse effects, and more

Sections

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

Interaction Checker

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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

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

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.

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])

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

Images

No images available for this drug.

Patient Handout

A Patient Handout is not currently available for this monograph.

Formulary

FormularyPatient Discounts

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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.

View explanations for tiers and restrictions

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.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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vibegron (Rx)