通用名称

fesoterodine fumarate

儿科标签批准日期

2021/6/17 0:00:00

特定指示/秒

Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg

标签更改摘要

- Safety and effectiveness have been established for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 6 years and older and weighing greater than 25 kg. - Use for treatment of NDO is supported by evidence from a randomized, open-label trial with an initial 12-week efficacy phase followed by a 12-week safety extension phase in pediatric patients from 6 years to 17 years - The most commonly reported adverse reactions in patients who received Toviaz 4 mg or 8 mg in Study 3 (≥2%) were diarrhea, UTI, dry mouth, constipation, abdominal pain, nausea, weight increase and headache. - Mean increases from baseline in heart rate were reported with both the 4 mg and 8 mg daily doses of Toviaz, with larger mean increases reported in pediatric patients who received the 8 mg daily dose. - Safety and effectiveness of Toviaz have not been established in pediatric patients younger than 6 years or weighing 25 kg or less. - Information on dosing, adverse reactions, PK parameters, and clinical trial.

治疗类别

Overactive/Neurogenic Bladder

立法类型

PREA + BPCA

产品说明书链接