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Safety Information

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.

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.

HARVONI can cause serious side effects,
including:
Hepatitis B virus reactivation:
Before starting
treatment with HARVONI, 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 or after treatment with
HARVONI. This may cause serious liver
problems, including liver failure and death.
Your healthcare provider will monitor you if
you are at risk for hepatitis B reactivation
during and after you stop taking HARVONI.
 
Tell your healthcare provider about all of your
medical conditions, including if you:
• have ever had hepatitis B virus infection
• have liver problems other than hepatitis C
infection
• had a liver transplant
• have severe kidney problems or are
on dialysis
• have HIV infection
• are pregnant or breastfeeding, or plan
to become pregnant or breastfeed
If you take HARVONI with ribavirin,
you should also read the ribavirin
Medication Guide for important
pregnancy-related information.
Tell your healthcare provider about all
the medicines you take:
• Keep a list that includes all prescription
and over-the-counter medicines, vitamins,
and herbal supplements, and show it to
your healthcare provider.
• HARVONI and certain medicines may
affect each other, or cause side effects.
HARVONI can cause serious side effects,
including:
Those in the “Most Important Information
about HARVONI” section.
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
The most common side effects of HARVONI
include
tiredness, headache and weakness.
These are not all the possible side effects of
HARVONI. Tell your healthcare provider if
you have any new symptoms while taking
HARVONI
HARVONI is a prescription medicine used
to treat people 12 years of age and older
(or weighing at least 77 pounds) with
chronic (lasting a long time) hepatitis C
genotype (GT) 1, 4, 5 or 6 infection with or
without cirrhosis (compensated). In adults
with GT 1 infection and advanced cirrhosis
(decompensated) or with GT 1 or 4
infection with or without cirrhosis
(compensated) who have had a liver
transplant, HARVONI is used with ribavirin.