通用名称

mirabegron

儿科标签批准日期

2021/3/25 0:00:00

特定指示/秒

Neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older

标签更改摘要

- Safety and effectiveness in pediatric patients aged 3 years and older have been established for the treatment of neurogenic detrusor overactivity (NDO) - Use is supported by evidence from a 52-week, open-label, baseline-controlled, multicenter, dose titration trial in pediatric patients 3 years of age and older with NDO. Results showed an improvement from baseline in maximum cystometric (bladder) capacity (MCC) - The most commonly reported adverse reactions in study 9 were UTI, nasopharyngitis, constipation, and headache. Increased mean systolic and diastolic blood pressures occurred in patients less than 12 years of age with larger increases in patients younger than 8 years of age. - Myrbetriq should be taken with food to reduce potential exposure-related risks, such as increased heart rate, as predicted by modeling of vital signs data in Study 9. - Information on dosing, PK parameters, adverse reactions, and clinical trials.

治疗类别

Genitourinary (GU)

立法类型

PREA + BPCA

产品说明书链接