Vibegron

<p>Overactive Bladder,&nbsp;Overactive Bladder in Men with BPH<br /> &nbsp;</p>

<p>Oral</p> <p>Tablet</p> <p>Overactive Bladder<br /> Indicated for overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and urinary frequency</p> <p>75 mg PO daily</p> <p>Overactive Bladder in Men with BPH<br /> Indicated for OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH)</p> <p>75 mg PO daily<br /> &nbsp;</p>

<p>Renal impairment<br /> Mild-to-severe (eGFR 15 to &lt;90 mL/min/1.73 m2): No dosage adjustment necessary<br /> End-stage renal disease (eGFR &lt;15 mL/min/1.73 m2) with or without hemodialysis: Not recommended</p>

<p>Hepatic impairment<br /> Mild-to-moderate (Child-Pugh A and B): No dosage adjustment necessary<br /> Severe (Child-Pugh C): Not recommended<br /> &nbsp;</p>

<p>May take with or without food<br /> &nbsp;</p>

<p>Hypersensitivity reaction to vibegron or any components of product<br /> &nbsp;</p>

<p>Urinary retention<br /> Urinary retention reported<br /> Risk increased in patients with bladder outlet obstruction and patients taking muscarinic antagonists medications; closely monitor patients during treatment<br /> Monitor for signs and symptoms of urinary retention<br /> Discontinue in patients who develop urinary retention</p> <p>Angioedema<br /> Angioedema of the face and/or larynx reported with use; angioedema reported to occur hours after first dose or after multiple doses; angioedema, associated with upper airway swelling, may be life-threatening<br /> If involvement of the tongue, hypopharynx, or larynx occurs, immediately discontinue therapy and provide appropriate therapy and/or measures necessary to ensure a patent airway; therapy is contraindicated in patients with known hypersensitivity to drug or excipients</p>

<p>Pregnancy<br /> 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</p> <p>Animal data<br /> Delayed fetal skeletal ossification was observed in rabbits at ~898-fold clinical exposure, in presence of maternal toxicity<br /> Developmental toxicity was observed in offspring at ~458-fold clinical exposure, in the presence of maternal toxicity<br /> No effects on offspring at 89-fold clinical exposure</p> <p>Lactation<br /> No data available on presence in human milk, effects on breastfed infants, or effects on milk production</p> <p>When a single oral dose of radiolabeled vibegron was administered to postnatal nursing rats, radioactivity was observed in milk</p> <p>If drug is present in animal milk, it is likely that drug will be present in human milk<br /> &nbsp;</p>

<p>Digoxin<br /> Vibegron increases digoxin maximal concentrations and systemic exposure<br /> Monitor serum digoxin concentrations before initiating, during therapy, and for dose titration<br /> Continue monitoring digoxin concentrations after discontinuing vibegron and adjust digoxin dose as needed<br /> &nbsp;</p>

<p>1-10%<br /> Urinary tract infection (6.6%)<br /> Headache (4%)<br /> Bronchitis (2.9%)<br /> Nasopharyngitis (2.8%)<br /> Diarrhea (2.2%)<br /> Nausea (2.2%)<br /> Upper respiratory tract infection (2%)<br /> Dry mouth (&lt;2%)<br /> Constipation (&lt;2%)<br /> Residual urine volume increased (&lt;2%)<br /> Urinary retention (&lt;2%)<br /> Hot flush (&lt;2%)<br /> &nbsp;</p>

<p>Selective human beta-3 adrenergic receptor agonist<br /> Activation of beta-3 adrenergic receptor increases bladder capacity by relaxing the detrusor smooth muscle during bladder filling</p>