Toviaz extended-release tablets
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
研究年龄
9 YEARS - 17 YEARS
6 YEARS - 17 YEARS
6 YEARS - 17 YEARS
学习类型
Safety,Pharmacokinetic,Tolerability
Safety,Tolerability
Efficacy,Safety,Pharmacokinetic,Tolerability
研究设计
Open-Label,Phase 2
Multicenter,Open-Label,Phase 3,Long-term
Multicenter,Randomized,Active Comparator,Parallel Group,Open-Label,Phase 3
国家
United States
Japan
United States,Belgium,Canada,Estonia,Finland,France,Germany,Greece,Italy,Japan,Korea, Republic of,Lithuania,Malaysia,Philippines,Poland,Russian Federation,Slovakia,South Africa,Spain,Sweden,Switzerland,Taiwan,Turkey,United Kingdom