What is EPCLUSA?

EPCLUSA is a prescription medicine used to treat adults and children 3 years of age and older with chronic (lasting a long time) hepatitis C (Hep C) genotype 1-6 infection with or without cirrhosis (compensated).

It is not known if EPCLUSA is safe and effective in children under 3 years of age.

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 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 and children 6 years of age and older include headache and tiredness. The most common side effects of EPCLUSA in children younger than 6 years are vomiting and problems with spitting up the medicine.

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.