通用名称

maraviroc

儿科标签批准日期

2020/10/30 0:00:00

特定指示/秒

Treatment of HIV-1 infection in children from birth to 2 years and dosing recommendations for pediatric patients weighing 10 kg to less than 30 kg

标签更改摘要

- The recommendation of Selzentry for the treatment of HIV-1 infection in neonates from birth to 6 weeks is based on safety and pharmacokinetic data obtained from clinical trial IMPAACT P2007. - In IMPAACT P2007, the safety and pharmacokinetic profiles of Selzentry were evaluated in 38 full-term HIV-1–exposed neonates (born to HIV-1–infected mothers) from birth through 6 weeks. - There are insufficient data to make dosing recommendations for use of Selzentry in pediatric patients concomitantly receiving potent CYP3A inhibitors and weighing less than 10 kg, or in any pediatric patients concomitantly receiving potent CYP3A inducers without a potent CYP3A inhibitor. - Selzentry is not recommended in pre-term neonates or in pediatric patients weighing less than 2 kg.

治疗类别

Antivirals

立法类型

BPCA Only

产品说明书链接