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Saxenda injection
儿科标签批准日期
2020/12/4 0:00:00
特定指示/秒
Adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in pediatric patients aged 12 years and older
标签更改摘要
- Safety and effectiveness as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management have been established in pediatric patients aged 12 years and older with body weight above 60 kg and an initial BMI corresponding to 30 kg/m2 or greater for adults (obese) by international cut-offs.
- Use for this indication is supported by a 56-week double-blind, placebo-controlled clinical trial in 251 pediatric patients aged 12 to 17 years, a PK study in pediatric patients, and studies in adults with obesity.
- In the pediatric clinical trial, there was one death due to suicide in a liraglutide-treated patient, one liraglutide-treated patient had an event of pancreatitis, more episodes of hypoglycemia confirmed by self-blood glucose monitoring occurred in liraglutide-treated patients compared to placebo, and mean increases in resting heart rate of 3 to 7 bpm from baseline were observed with liraglutide treated patients.
- Safety and effectiveness have not been established in patients less than 12 years old.
- Information on dosing, adverse reactions, PK parameters, and clinical trials.