通用名称

dasatinib

儿科标签批准日期

2018/12/21 0:00:00

特定指示/秒

Pediatric patients one year and older with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy

标签更改摘要

- Safety and effectiveness of Sprycel in combination with chemotherapy have been demonstrated in pediatric patients one year and over with newly diagnosed Ph+ ALL. - Use in pediatric patients is supported by evidence from one pediatric study. There are no data in children under 1 year. - The safety profile in pediatric patients was comparable to that reported in studies in adults. - Monitor bone growth and development in pediatric patients. - Five patients with Ph+ ALL 2 to 10 years of age received at least one dose of SPRYCEL tablet dispersed in juice. The exposure for dispersed tablets was 36% lower as compared to intact tablets in pediatric patients. Due to the limited available clinical data, it is unclear whether dispersing Sprycel tablets significantly alters the safety and/or efficacy of Sprycel. - New indication

治疗类别

N/A

立法类型

BPCA Only

产品说明书链接