通用名称

fingolimod

儿科标签批准日期

2021/12/23 0:00:00

特定指示/秒

Relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in pediatric patients 10 years of age and older and weighing less than or equal to 40 kg

标签更改摘要

- Safety and effectiveness of fingolimod for the treatment of relapsing forms of multiple sclerosis in pediatric patients 10 to less than 18 years of age were established in one randomized, double-blind clinical study in 215 patients (fingolimod n = 107; intramuscular interferon (IFN) beta-1a n = 108). - In the controlled pediatric study, the safety profile in pediatric patients (10 to less than 18 years of age) receiving fingolimod capsules daily was similar to that seen in adult patients. In the pediatric study, cases of seizures were reported in 5.6% of fingolimod-treated patients and 0.9% of interferon beta-1a-treated patients. - It is recommended that pediatric patients, if possible, complete all immunizations in accordance with current immunization guidelines prior to initiating therapy. - Safety and effectiveness in pediatric patients below the age of 10 years have not been established. - Information on dosing, adverse reactions, PK parameters, and clinical trials. - New dosage form.

治疗类别

Spinal Cord Injury

立法类型

PREA Only

产品说明书链接