Tivicay tablets
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.
研究年龄
4 WEEKS - 17 YEARS
4 WEEKS - 17 YEARS
学习类型
Safety,Pharmacokinetic
Safety,Pharmacokinetic,Tolerability
研究设计
Multicenter,Randomized,Active Comparator,Open-Label,Phase 2,Phase 3,Non-Inferiority
Multicenter,Open-Label,Dose Ranging,Phase 1,Phase 2
国家
South Africa,Uganda,Zimbabwe
United States,Botswana,Brazil,Kenya,South Africa,Tanzania, United Republic of,Thailand,Uganda,Zimbabwe