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.
For additional information, call the EPCLUSA Education Line at 1-844-4-EPCLUSA (1-844-437-2587).
For additional information about EPCLUSA Support Path®,
call 1-855-7-MYPATH(1-855-769-7284).
Phone: (650) 574-3000
Fax: (650) 578-9264
Address: Gilead Sciences, Inc. 333 Lakeside Drive Foster City, CA 94404
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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.
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.
