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
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).
Please see Important Facts about
EPCLUSA including Important Warning.
