当前位置:药药网 / 数据中心 / 儿科标签更改电子表格2021
Vocabria tablets
儿科标签批准日期
2021/12/20 0:00:00
特定指示/秒
At-risk adults and adolescents weighing at least 35 kg for short-term pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection.
标签更改摘要
Treatment of HIV-1 Infection
- Safety and efficacy have not been established in pediatric patients with HIV-1 infection.
HIV-1 Pre-Exposure Prophylaxis
- Safety and effectiveness of VOCABRIA for HIV-1 PrEP in at-risk adolescents weighing at least 35 kg is supported by data from 2 adequate and well-controlled trials of VOCABRIA for HIV-1 PrEP in adults with additional safety and pharmacokinetic data from studies in HIV-1 infected adults who were administered CABENUVA and in HIV-1 infected pediatric patients who were administered separate components of CABENUVA in addition to their current antiretroviral therapy.
- APRETUDE for HIV-1 PrEP is being evaluated in 2 open-label multicenter clinical trials in adolescent individuals. Fifty-nine adolescents have been enrolled. Of these, 54 adolescent participants received one or more injections after receiving VOCABRIA. In adolescents receiving VOCABRIA and APRETUDE for HIV-1 PrEP, the safety data were comparable to the safety data reported in adults receiving APRETUDE for HIV-1 PrEP.
- While using APRETUDE, HIV-1 testing should be conducted prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) and prior to each injection of APRETUDE.
- Adolescents may benefit from more frequent visits and counseling to support adherence to the dosing schedule.
- The safety, efficacy, and pharmacokinetics of VOCABRIA in pediatric participants younger than 12 years of age or weighing <35 kg have not been established.
- Information on dosing, adverse reactions, PK parameters, and clinical studies.
- New dosage form.
- New indication.
- Postmarketing studies.