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艾滋病长效治疗新药Cabenuva/Vocabria(商品名:Cabenuva)获美国批准上市(二)
2021-01-23 14:05:57 来源: 作者: 【 】 浏览:3588次 评论:0
胶制成的。
储存和处理
将CABENUVA在原始纸箱中的2°C至8°C(36°F至46°F)的冰箱中存放,直到可以使用为止。不要冻结。请勿与任何其他产品或稀释剂混合。
给药前,应将小瓶置于室温(不超过25°C [77°F])。小瓶在室温下可能会在纸箱中保留最多6个小时。如果6小时内未使用,则必须将其丢弃。
将悬浮液吸入各自的注射器后,应尽快进行注射,但可能会在注射器中保留最多2个小时。如果2小时如果超出此范围,则必须丢弃药物,注射器和针头[请参阅剂量和用法]。
完整说明资料附件:
https://gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/
Prescribing_Information/Cabenuva/pdf/CABENUVA-PI-PIL-IFU2-IFU3.PDF
------------------------------------------------------------
U.S. FDA Approval of CABENUVA(rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV
U.S. Food and Drug Administration(FDA)has approved CABENUVA(consisting of Janssen's rilpivirine and ViiV Healthcare's cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. The novel regimen was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen's 25-year commitment to make HIV history. In the U.S., ViiV Healthcare is the marketing authorization holder for CABENUVA.
About CABENUVA(rilpivirine and cabotegravir)
CABENUVA is approved as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. CABENUVA is administered by a healthcare provider once-monthly as two individual intramuscular injections in the buttocks.
The complete regimen combines rilpivirine, a non-nucleoside reverse transcriptase inhibitor(NNRTI) developed by Janssen Sciences Ireland UC, with the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare.
INSTIs, like cabotegravir, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells(T-cells).This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection.
Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which in turn stops the virus from multiplying.  
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