Product Focus: Gemtesa® (Vibegron)

May 10, 2022 | Blog, Clinical Insight

Description:

Vibegron is a selective beta-3 adrenergic agonist. Like mirabegron, vibegron relaxes detrusor smooth muscle and increases bladder capacity, reducing incontinence.

Indication & Dosage:

For the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urinary
urgency, and urinary frequency.
Oral dosage:

  • Adults: 75 mg PO once daily
  • Adults & Geriatric Maximum Daily Dose: 75 mg/ day PO

Administration:

Administer with or without food. Swallow tablets whole with a glass of water. 75mg Tablets may be crushed
and mixed with a tablespoonful (~15 mL) of applesauce. Swallow applesauce mixture immediately after
preparation, followed by a glass of water.
No titration required.

Warnings/ Precautions/ Disease-related concerns:

  • Bladder flow obstruction:

Use with caution in patients with bladder outlet obstruction and in patients using concomitant muscarinic antagonists; may increase the risk of urinary retention. Monitor for signs and symptoms of urinary retention; discontinue use if urinary retention occurs.

Adverse Reactions:

Endocrine & metabolic: Hot flash (<2%),
Gastrointestinal: Constipation (<2%), diarrhea (2%), nausea (2%), xerostomia (<2%)
Genitourinary: Increased post-void residual urine volume (<2%), urinary retention (<2%),
Nervous system: Headache (4%),
Respiratory: Nasopharyngitis (3%), upper respiratory tract infection (2%)
Postmarketing: Dermatologic: Eczema, pruritus, skin rash

Special Populations:

  • Patients with Hepatic Impairment Dosing:

Mild to moderate hepatic impairment (Child-Pugh A and B): No dosage adjustment is needed.
Severe hepatic impairment (Child-Pugh C): Use is not recommended; vibegron has not been
studied in this population.

  • Patients with Renal Impairment Dosing:

eGFR 15 mL/minute/1.73 m2 or more: No dosage adjustment is needed. eGFR 0 to 14 mL/minute/1.73
m2 (with or without hemodialysis): Use not recommended; vibegron has not been studied in this population.

Dosage Form/Storage:

Thirty (30) 75mg tablets in a 60 cc HDPE bottle with a child-resistant cap, NDC 73336-075-30 Ninety (90) tablets in a 60 cc HDPE bottle with a child-resistant cap, NDC 73336-075-90

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F)

Gemtesa (R) Vibegron info graphic
Gemtesa (R) (Vibegron) info-graphic

FOR COMPLETE PRESCRIBING INFORMATION:
medinfo@urovant.com – CALL: 1-833-UROVANT


Reference:

66190 – Gemtesa (vibegron) tablets package insert. Irvine, CA: Urovant Sciences

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John Wind, RPH

As HealthDirect’s Consultant Pharmacist Manager, John provides leadership and guidance to the Consultant Pharmacist team.  John has been provided LTC communities with personalized clinical consulting for more than 20 years.

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