EPCLUSA EDUCATOR
FOLLOW-UP

EPCLUSA is a prescription medicine used to
treat adults with chronic hepatitis C (Hep C)
genotype 1-6 infection with or without cirrhosis
(compensated).

Important Safety Information

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

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

EPCLUSA can cause serious side effects, including:

EPCLUSA can cause serious side effects, including:

  • Hepatitis B virus reactivation: Before starting
    EPCLUSA 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 EPCLUSA. 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 EPCLUSA.

    Hepatitis B virus reactivation:
    Before starting EPCLUSA 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 taking
    EPCLUSA. 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 EPCLUSA.

See complete Important Safety
Information below

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IMPORTANT SAFETY INFORMATION

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

EPCLUSA can cause serious side effects, including:

  • •

    Hepatitis B virus reactivation: Before starting EPCLUSA 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 EPCLUSA. 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 EPCLUSA.

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

  • •

    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 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 EPCLUSA will harm your unborn baby or pass into your breast milk.

    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 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 EPCLUSA will harm your unborn baby or pass into your breast milk. If you take EPCLUSA 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. EPCLUSA and certain other medicines may affect each other, or may cause side effects.

    • What are the possible side effects of EPCLUSA?

    Serious side effects may also include:

  • •

    Slow heart rate (bradycardia): EPCLUSA, when taken with amiodarone (Cordarone®, Nexterone®, Pacerone®), a medicine used to treat certain heart problems, may cause slow heart rate. In some cases slow heart rate has led to death or the need for a pacemaker when amiodarone is taken with medicines containing sofosbuvir. Get medical help right away if you take amiodarone with EPCLUSA 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 EPCLUSA in adults include headache and tiredness.

    • These are not all the possible side effects of EPCLUSA. Call your doctor for medical advice about side effects.

    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.

    What is EPCLUSA?

    EPCLUSA is a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C (Hep C) genotype 1-6 infection with or without cirrhosis (compensated).

    EPCLUSA is a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C (Hep C) genotype 1-6 infection with or without cirrhosis (compensated). In those with advanced cirrhosis (decompensated), EPCLUSA is used with ribavirin.

    Please see Important Facts about EPCLUSA including Important Warning.

    Tap for Important Safety Information about EPCLUSA including Important Warning on hepatitis B reactivation.