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Apretude extended-release injectable suspension
儿科标签批准日期
2021/12/20 0:00:00
特定指示/秒
HIV-1 pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at-risk adults and pediatric patients 12 to 17 years weighing at least 35 kg
标签更改摘要
- Safety and effectiveness of APRETUDE 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 APRETUDE 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 subjects 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. In adolescents receiving 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 and testing schedule.
- Safety, efficacy, and pharmacokinetics of APRETUDE 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.