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, and assess abdomen for bladder distention prior to and periodically during therapy, particularly in patients at ↑ risk of bladder outlet obstruction. If urinary retention occurs,  discontinue vibegron.
  • Geri:  Assess older adults for anticholinergic effects (sedation and weakness).

Implementation

  • PO Administer once daily without regard to food. 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 ↑ dietary bulk, fluid intake, and 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.
  • Rep:  Advise women 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, incontinence) in patients with a neurogenic or overactive bladder.