通用名称

dolutegravir

儿科标签批准日期

2020/6/12 0:00:00

特定指示/秒

HIV-1–infected, pediatric patients weighing 14 kg to less than 30 kg; revision of the dosing recommendations for pediatric patients weighing 30 kg to less than 40 kg

标签更改摘要

- Expanded the indication to include patients weighing 14 kg to less than 30 kg; previously approved down to pediatric patients weighing at least 30 kg. - Safety and effectiveness of Tivicay and Tivicay PD have not been established in pediatric patients less than 4 weeks or weighing less than 3 kg or in any pediatric patients who are integrase strand transfer inhibitor (INSTI)-experienced with documented or clinically suspected resistance to other INSTIs. - Revised dosing recommendations for treatment-naïve and treatment experienced, INSTI-naïve patients weighing 30 kg to less than 40 kg. - Tivicay and Tivicay PD are not bioequivalent and are not interchangeable on a milligram-per-milligram basis. - Safety profile is similar to those observed in adults. - Information on dosing, adverse reactions, PK parameters, and clinical studies. - Postmarketing study. - New dosage regimen.

治疗类别

Antivirals

立法类型

PREA + BPCA

产品说明书链接