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What is HARVONI?

HARVONI is a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C (Hep C) genotype (GT) 1, 4, 5 or 6 infection with or without cirrhosis (compensated). In those with GT 1 and advanced cirrhosis (decompensated) or with GT 1 or 4 with or without cirrhosis (compensated) who have had a liver transplant, HARVONI is used with ribavirin.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about HARVONI?

HARVONI can cause serious side effects, including:

  • Hepatitis B virus reactivation: Before starting HARVONI treatment, your healthcare provider will do blood tests to check for hepatitis B infection. If you have ever had hepatitis B, the hepatitis B virus could become active again during and after treatment with HARVONI. This may cause serious liver problems, including liver failure and death. If you are at risk, your healthcare provider will monitor you during and after taking HARVONI.

  • What should I tell my healthcare provider before taking HARVONI?

  • Tell your healthcare provider about all of your medical conditions, including if you have ever had hepatitis B infection, liver problems other than hepatitis C infection, or a liver transplant; if you have severe kidney problems or are on dialysis; if you have HIV; or if you are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if HARVONI will harm your unborn baby or pass into your breast milk. If you take HARVONI with ribavirin, you should also read the ribavirin Medication Guide for important pregnancy-related information.

  • Tell your healthcare provider and pharmacist about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. HARVONI and certain other medicines may affect each other, or may cause side effects.

  • What are the possible side effects of HARVONI?

    Serious side effects may also include:

  • Slow heart rate (bradycardia): HARVONI, when taken with amiodarone (Cordarone®, Nexterone®, Pacerone®), a medicine used to treat certain heart problems, may cause slow heart rate, which in some cases has led to death or the need for a pacemaker. Get medical help right away if you take amiodarone with HARVONI and get any of the following symptoms: fainting or near-fainting, dizziness or lightheadedness, not feeling well, weakness, extreme tiredness, shortness of breath, chest pains, confusion, or memory problems.
    The most common side effects of HARVONI include tiredness, headache, and weakness.

  • You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

    Please see Important Facts about HARVONI including Important Warning on hepatitis B reactivation.



    HARVONI and the HARVONI logo are trademarks of Gilead Sciences, Inc. or its related companies.

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    IMPORTANT
    SAFETY
    INFORMATION

    重要安全信息

    关于吉三代(EPCLUSA),我应该了解哪些最重要的信息?

    吉三代(EPCLUSA)可引起严重的副作用,包括:

  • 激活乙型肝炎病毒: 在开始(吉三代)EPCLUSA治疗之前,您的医疗服务人员将进行对你进行血液检查以确定是否有乙型肝炎感染。如果您曾患过乙型肝炎,乙型肝炎病毒可能会在使用吉三代(EPCLUSA)治疗期间和治疗之后再次活跃起来。这可能导致严重的肝脏问题,包括肝功能衰竭和死亡。如果存在以上风险,要有医疗服务人员在您服用吉三代(EPCLUSA)期间和服用后后,进行实时监控。

  • 在服用吉三代(EPCLUSA)之前,应该告诉医生您的病史?

  • 告诉您的医务人员您的所有医疗状况, 包括您是否曾感染过乙型肝炎或肝炎以外的肝脏问题; 如果您有严重的肾脏问题或正在进行透析; 如果你有艾滋病毒; 或者如果您怀孕或哺乳,或计划怀孕或哺乳。目前尚不清楚EPCLUSA是否会伤害未出生的婴儿或进入母乳。如果您服用含有利巴韦林的EPCLUSA,您还应该阅读利巴韦林药物指南,了解重要的妊娠相关信息。

  • 告诉您的医疗保健提供者和药剂师您服用的所有药物, 包括处方药和非处方药,维生素和草药补充剂。EPCLUSA和某些其他药物可能相互影响,或可能引起副作用。

  • 吉三代(EPCLUSA)有哪些可能的副作用?

    严重的副作用还可能包括:

  • 慢心脏率(心动过缓): 吉三代 (EPCLUSA),当与胺碘酮(可达龙®,Nexterone ®,Pacerone ®)联合使用,可能会导致心脏速度放缓。在某些情况下,当胺碘酮与含有sofosbuvir的药物一起服用时,心率减慢有可能导致死亡。如果您服用吉三代(EPCLUSA)+胺碘酮时,如果出现以下任何症状,请立即寻求医生帮助: 昏厥或接近昏厥,头晕或头晕,不舒服,虚弱,极度疲倦,呼吸急促,胸痛,意识模糊或记忆力不集中。

  • 我们鼓励您向FDA报告处方药的负面副作用。请访问 www.kangantu.com 或者致电: 4006-120-156。

    吉三代(EPCLUSA)最常见的副作用包括头痛和疲倦。如果您有任何困扰您或副作用持续不消失,请告知您的医务人员。

    我们鼓励您向FDA报告处方药的负面副作用。

    什么是吉三代?

    CLUSA是一种处方药,用于治疗慢性(持续很长时间)丙型肝炎(Hep C)基因型1,2,3,4,5或6种感染,有或没有肝硬化(补偿)。在患有晚期肝硬化(失代偿)的患者中,EPCLUSA与利巴韦林一起使用。

    请参阅有关吉三代的重要事实,包括重要警告。


    点击使用和有关EPCLUSA的重要安全信息,包括乙型肝炎再激活的重要警告。