通用名称

atazanavir/cobicistat

儿科标签批准日期

2020/7/31 0:00:00

特定指示/秒

HIV-1 infection in pediatric patients weighing at least 35 kg

标签更改摘要

- Safety and effectiveness for the treatment of HIV-1 infection in pediatric patients weighing at least 35 kg was established through a study with components of EVOTAZ. Use for this indication is supported by evidence from adequate and well-controlled studies in adults, and by pharmacokinetic, safety, and virologic data from an open-label trial of components of Evotaz in pediatric patients with HIV-1 infection aged 12 years and older. - Safety in these subjects through 48 weeks was similar to that in antiretroviral treatment-naive adults [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.2)]. - Safety and effectiveness in the pediatric population weighing less than 35 kg have not been established. Atazanavir, a component of Evotaz, is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus. - Information on dosing, adverse reactions, PK parameters, and clinical trial. - Postmarketing study.

治疗类别

AIDS & AIDS Related Drugs

立法类型

PREA Only

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