葡糖醛酸基转移酶（UGT）1A1或细胞色素P450（CYP）3A4的药物可能会降低CABENUVA成分的血浆浓度。
•CABENUVA应谨慎与已知有尖端扭转风险的药物联合使用。
在特定人群中使用
•妊娠期：口服利匹韦林后，与产后相比，妊娠期的暴露量通常较低。
包装供应/储存和处理
供应方式
CABENUVA分为两个剂量套件。每个试剂盒包含1小瓶卡博韦缓释注射混悬液和1小瓶利匹韦林缓释注射混悬浮液，共包装如下：CABENUVA 400 mg/600 mg试剂盒（NDC 49702-253-15），包含：
•一瓶单剂量卡博韦缓释注射混悬液，含400mg/mL（200mg/mL）卡博韦。
•一小瓶含有600mg/mL（300mg/mL）利匹韦林的利匹韦灵缓释注射混悬液CABENUVA 600mg/900 mg试剂盒（NDC 49702-240-15），包含：
•一个单剂量小瓶的卡博替拉韦缓释注射混悬液，含有600mg/3mL（200mg/mL）的卡博替拉韦。
•一个单剂量小瓶的利匹韦林缓释注射混悬液，含有900毫克/3毫升（300毫克/毫升）的利匹韦林。每个给药套件还包含2个注射器、2个注射器标签、2个小瓶适配器和2个用于肌肉注射的针头（23号，1½英寸）。瓶塞不是用天然橡胶乳胶制成的。
储存和处理
将CABENUVA储存在原始纸箱中的冰箱中，温度为2°C至8°C（36°F至46°F），直至可以使用。不要冻结。不要与任何其他产品或稀释剂混合。
给药前，应将小瓶置于室温下（不超过25°C[77°F]）。小瓶可以在室温下保持在纸箱中长达6小时；不要放回冰箱。如果在6小时内未使用，则必须丢弃。
一旦悬浮液被吸入各自的注射器中，应尽快进行注射，但可以在注射器中停留长达2小时。装满的注射器不应放在冰箱中。如果药物在注射器中停留超过2小时，则必须丢弃已填充的注射器和针头[参见剂量和用法]。
请参阅随附的Cabenuva完整处方信息：
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1698baf3-f895-4c42-a1b1-e9ee3f20da36
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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.
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.
PRINCIPAL DISPLAY PANEL
NDC 49702-253-15
CABENUVA
Cabotegravir extended-release
injectable suspension
400 mg/2mL(200mg/mL)
co-packaged with
Rilpvirine extended-release
injectable suspension
600 mg/2mL(300 mg/mL)
Rx Only
For gluteal intramuscular use only.
Healthcare Professional administration only.
Contents:
•1 Cabotegravir single-dose vial
•1 Rilpivirine single-dose vial
•2 Vial adapters
•2 Syringes
•2 Injection needles(23guage, 1 ½ inch)
•2 Syringe labels
•Prescribing Information
•Patient Information
•Instructions for Use
Store in refrigerator at 2°C to 8°C (36°F to 46°F).
Do not freeze.
Discard unused portion.
Prior to administration, bring vials to room temperature (not to exceed 25°C (77°F).
Vials may remain at room temperature for up to 6 hours. If not used within 6 hours, they must be discarded.
400 mg/600mg Kit
PRINCIPAL DISPLAY PANEL
NDC 49702-240-15
CABENUVA
Cabotegravir extended-release
injectable suspension
600mg/3mL(200mg/mL)
co-packaged with
Rilpvirine extended-release
injectable suspension
900mg/3mL(300mg/mL)
Rx Only
For gluteal intramuscular use only.
Healthcare Professional administration only.
Contents:
•1 Cabotegr |
