通用名称

linaclotide

儿科标签批准日期

2021/8/24 0:00:00

特定指示/秒

Irritable bowel syndrome with constipation

标签更改摘要

- Safety and effectiveness in patients less than 18 years of age have not been established. - Contraindicated in patients less than 2 years of age. In nonclinical studies, deaths occurred within 24 hours in neonatal mice (human age equivalent of approximately 0 to 28 days) following oral administration of linaclotide which increased fluid secretion as a consequence of age-dependent elevated GC-C agonism resulting in rapid and severe dehydration, as described in Juvenile Animal Toxicity Data. - A GC-C ontogeny study measured GC-C mRNA expression levels in duodenal and colonic mucosal tissue samples from children aged 6 months to less than 18 years (N=99) to evaluate the risk of diarrhea and severe dehydration due to GC-C agonism in children. The results showed no age-dependent trend in GC-C intestinal expression in children 2 to less than 18 years. However, there are insufficient data available on GC-C intestinal expression in children less than 2 years to assess the risk of developing diarrhea and its potentially serious consequences. - Information on safety, including a revised boxed warning, and clinical trial. - Postmarketing study.

治疗类别

Irritable Bowel Syndrome

立法类型

PREA + BPCA

产品说明书链接

书号

N/A

研究年龄

N/A

学习类型

N/A

研究设计

N/A

登记的患者

N/A

患者分析

N/A

中心的数量

N/A

国家数量

N/A

西班牙裔拉美裔/拉丁裔总计

N/A

非西班牙裔/非拉丁裔总人数

N/A

总数#种族不明

N/A

亚裔学生总数

N/A

黑人总数

N/A

白人总数

N/A

夏威夷或太平洋岛民总数

N/A

美洲印第安人/阿拉斯加本地人总数

N/A

其他种族总计

N/A

未知种族总数

N/A

国家

N/A