Your Health, We Care
Another NameLuciVibe、维贝格龙
IndicationsOveractive bladder (OAB)
Reg No.07 L 1140/24
Inspection NO.
It is a drug molecule that has been marketed.
On December 24, 2020, the United States Food and Drug Administration (FDA) approved Verbegelone for the treatment of patients with urge urinary incontinence (UUI), urinary urgency, and frequent overactive bladder (OAB).
Vibegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
Overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
Veractive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
There are no available data on Vibegron use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
In animal studies, no effects on embryofetal development were observed following administration of vibegron during the period of organogenesis at exposures approximately 275-fold and 285-fold greater than clinical exposure at the recommended daily dose of Vibegron, in rats and rabbits, respectively. Delayed fetal skeletal ossification was observed in rabbits at approximately 898-fold clinical exposure, in the presence of maternal toxicity. In rats treated with vibegron during pregnancy and lactation, no effects on offspring were observed at 89-fold clinical exposure. Developmental toxicity was observed in offspring at approximately 458-fold clinical exposure, in the presence of maternal toxicity. No effects on offspring were observed at 89-fold clinical exposure.
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies carry some risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
There are no data on the presence of vibegron in human milk, the effects of the drug on the breastfed infant, or the effects on milk production. When a single oral dose of radiolabeled vibegron was administered to postnatal nursing rats, radioactivity was observed in milk . When a drug is present in animal milk, it is likely that the drug will be present in human milk.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Vibegron and any potential adverse effects on the breastfed infant from Vibegron or from the underlying maternal condition.
The safety and effectiveness of Vibegron in pediatric patients have not been established.
Of 526 patients who received Vibegron in the clinical studies for OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency, 242 (46%) were 65 years of age or older, and 75 (14%) were 75 years of age or older. No overall differences in safety or effectiveness of Vibegron have been observed between patients 65 years of age and older and younger adult patients.
No dosage adjustment for Vibegron is recommended for patients with mild, moderate, or severe renal impairment (eGFR 15 to <90 mL/min/1.73 m2 ). Vibegron has not been studied in patients with eGFR <15 mL/min/1.73 m2 (with or without hemodialysis) and is not recommended in these patients.
No dosage adjustment for Vibegron is recommended for patients with mild to moderate hepatic impairment (Child-Pugh A and B). Vibegron has not be studied in patients with severe hepatic impairment (Child-Pugh C) and is not recommended in this patient population.
There is no experience with inadvertent Vibegron overdosage. In case of suspected overdose, treatment should be symptomatic and supportive.
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)
Mean vibegron Cmax and AUC increased in a greater than dose-proportional manner up to 600 mg (8 times the approved recommended dosage). Steady state concentrations are achieved within 7 days of once daily dosing. The mean accumulation ratio (Rac) was 1.7 for Cmax and 2.4 for AUC0-24hr.
from FDA,2020.12
