vibegron

General

Pronunciation:
vye-beg-ron


Trade Name(s)

  • Gemtesa

Ther. Class.

urinary tract antispasmodics

Pharm. Class.

beta-adrenergic agonists

Indications

Treatment of symptoms of overactive bladder (OAB) including urge urinary incontinence, urgency, and frequency.

Action

As a selective beta-3 adrenergic agonist, it relaxes the detrusor smooth muscles, which increases bladder capacity during storage phase of bladder fill-void cycle.

Therapeutic Effect(s):

Reduction in OAB symptoms.

Pharmacokinetics

Absorption: Unknown.

Distribution: Extensively distributed to extravascular tissues.

Metabolism and Excretion: Some metabolism in liver via CYP3A4 isoenzyme. Primarily excreted in feces (59%; 54% as unchanged drug), with 20% excreted in urine (19% as unchanged drug).

Half-life: 30.8 hr.

TIME/ACTION PROFILE (plasma concentrations)

ROUTEONSETPEAKDURATION
POunknown1–3 hr24 hr

Contraindication/Precautions

Contraindicated in:

  • Hypersensitivity
  • End-stage renal disease
  • Severe hepatic impairment.

Use Cautiously in:

  • Bladder outlet obstruction/concurrent antimuscarinics (↑ risk of urinary retention);
  • OB:   Safety not established in pregnancy
  •  Lactation:  Safety not established in breastfeeding
  • Pedi:   Safety and effectiveness not established in children.

Adverse Reactions/Side Effects

EENT: nasopharyngitis, upper respiratory tract infection

GI: constipation, diarrhea, dry mouth, nausea

GU: urinary retention, urinary tract infection

Neuro: headache

Resp: bronchitis

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

May ↑ levels and risk of toxicity of  digoxin ; closely monitor serum digoxin concentrations.

Route/Dosage

PO (Adults): 75 mg once daily.

Availability

Tablets: 75 mg

Assessment

  • Monitor voiding pattern and intake and output ratios, and assess abdomen for bladder distention prior to and periodically during therapy. Catheterization may be used to assess postvoid residual.
  • Geri:  Assess geriatric patients for anticholinergic effects (sedation and weakness).

Implementation

  • PO Administer once daily without regard to food.  DNC: Swallow tablets whole with a glass of water. Tablets also may be crushed, mixed with a tablespoon (15 mL) of applesauce and taken immediately with a glass of water.

Patient/Family Teaching

  • Instruct patient to take vibegron as directed. Advise patient to read  Patient Information  before starting therapy and with each Rx refill in case of changes.
  • Advise patient to notify health care professional if urinary retention (cannot empty bladder) occurs or if constipation persists. Discuss methods of preventing constipation, such as increasing dietary bulk, increasing fluid intake, and increasing mobility.
  • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
  • Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

Relief of bladder spasm and associated symptoms (frequency, urgency, nocturia, and incontinence) in patients with a neurogenic or overactive bladder.

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