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.
While your healthcare provider is the best resource, you can find the answers to some of the most frequently asked questions about EPCLUSA and Hep C below.
Want to talk to a person instead?
with EPCLUSA? How should I take EPCLUSA? What should I tell my healthcare provider before taking EPCLUSA? What if I had previously struggled with drug addiction? Does EPCLUSA need to be taken with other medicines to treat Hep C? Can I take EPCLUSA if I was not cured with a previous Hep C treatment? Can I take EPCLUSA if I have cirrhosis?
Pill not actual
size.
What are the possible side effects of EPCLUSA (sofosbuvir/velpatasvir)?
Please see Important Facts about EPCLUSA including Important Warning about hepatitis B
reactivation.
The most common side effects of EPCLUSA include headache and tiredness.
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.
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
-
memory problems
- shortness of breath
- chest pains
- confusion
- memory problems
Tell your healthcare provider if you have any side effect that bothers you or does
not go
away.
These are not all the possible side effects of EPCLUSA. For more information, ask your
healthcare
provider or pharmacist.
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.
Please see Important Facts about EPCLUSA including Important Warning about hepatitis B reactivation on EPCLUSA.com.
How long is treatment
with EPCLUSA?
Treatment duration with EPCLUSA is
12 weeks for everyone, no matter
your
genotype.
Pill not actual
size.
How should I take EPCLUSA?
Your EPCLUSA dosing should follow exactly what your healthcare provider tells you.
Don’t stop taking EPCLUSA without first talking with your healthcare provider.
Take 1 EPCLUSA pill each day with or without food.
It’s important that you don’t miss or skip doses of
EPCLUSA
during
treatment.
If you take too much EPCLUSA, call your healthcare provider or go to the nearest hospital
emergency room right away.
If you take EPCLUSA with ribavirin, you should also read the Medication Guide for ribavirin,
including dosing information.
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. 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. Also, tell them if you’ve struggled with addiction.
What if I had previously struggled with drug addiction?
Have an open and honest conversation with your healthcare provider. Tell your doctor if you’re currently taking any medication to treat your addiction, such as methadone, a medication-assisted treatment for addiction.
Does EPCLUSA need to be taken with other medicines to treat Hep C?
No additional medicines are required for the majority of patients. EPCLUSA is one
pill, taken once daily, with or without food.
EPCLUSA with ribavirin is recommended for certain patients with advanced cirrhosis
(decompensated). If you take EPCLUSA with ribavirin,
you should also read the ribavirin Medication Guide for important pregnancy-related
information.
Take EPCLUSA exactly as your healthcare provider tells you to take it.
EPCLUSA and certain other medicines may affect each other, or may cause side effects.
Consult your healthcare provider with any treatment questions.
Can I take EPCLUSA if I was not cured with a previous Hep C treatment?
Even if your previous Hep C treatment was unsuccessful, EPCLUSA may work. In clinical studies, EPCLUSA was proven effective in treating chronic Hep C patients who had previously failed a peginterferon alfa- and ribavirin-based regimen, with or without a protease inhibitor. Protease inhibitors are a class of antiviral drugs used to treat Hep C and work by stopping the virus from replicating. Examples of drugs that are protease inhibitors are Incivek® (telaprevir) and Victrelis® (boceprevir).
Speak with your Hep C Specialist to find out if EPCLUSA is right for you.
If you take EPCLUSA with ribavirin, you should also read the ribavirin Medication Guide for important pregnancy-related information.
If you were previously treated for Hep C with something other than peginterferon alfa and ribavirin, such as a protease inhibitor, learn about another treatment option that may be right for you. Protease inhibitors are a class of antiviral drugs used to treat Hep C, which work by stopping the virus from replicating. Examples of drugs that are protease inhibitors are Incivek® (telaprevir) and Victrelis® (boceprevir).
Can I take EPCLUSA if I have cirrhosis?
EPCLUSA is a prescription medicine used to treat adults with chronic (lasting a long
time) hepatitis C (Hep C) genotype 1, 2, 3, 4, 5, or 6
infection with or without cirrhosis
(compensated). In those with advanced cirrhosis (decompensated), EPCLUSA is used with ribavirin.
Speak with your Hep C Specialist to find out if
EPCLUSA is right for you.
If you take EPCLUSA with ribavirin,
you should also read the ribavirin Medication Guide for important pregnancy-related information.
If you
have cirrhosis, it may not be too late to try EPCLUSA to treat your Hep C.
Why is it important to stay on EPCLUSA for the full time?
Each day, the Hep C virus makes billions of copies of itself in your body. Staying on EPCLUSA for the full time gives it the best chance to fight the virus. It’s important that you don’t miss or skip doses of EPCLUSA during treatment.
What should I bring with me when I visit my Hep C doctor?
When visiting your Hep C Specialist, be prepared to share your medical history. It’s a good idea to bring along:
-
Your medical records
-
A list of any medicines you are taking including:
-
Prescription and/or
over-the-counter medicines -
Vitamins
-
Herbal supplements
- A list of any questions you may have for your Hep C Specialist
Be prepared to talk about any symptoms you may be experiencing, even if you don’t
think they seem related to your liver or Hep C.
You may wish to write down this information prior to
your visit and bring it with you.
How do I fill my EPCLUSA prescription?
If you and your Hep C Specialist decide EPCLUSA is right for you, your Hep C Specialist will submit your prescription directly to a specialty pharmacy.
What is a specialty pharmacy?
Specialty pharmacies provide medicines that have special delivery, storage, or administration requirements, and typically deliver them directly to patients by US mail or a delivery service.
What if I miss a dose of EPCLUSA?
It’s important to take EPCLUSA as prescribed by your healthcare provider. If you miss a dose, be sure to take EPCLUSA the very next day. Never take more than one EPCLUSA pill per day. If you take too much EPCLUSA, call your healthcare provider or go to the nearest emergency room right away.
After I have finished treatment, how long will it take to find out if I’m cured?
Being “cured” of Hep C is defined as when the virus cannot be detected in the blood when measured at least 3 months after treatment is completed. Your doctor will use a simple blood test to determine your success with treatment.
Are there ways I could save money on EPCLUSA (sofosbuvir/velpatasvir)?
Treatment with EPCLUSA may cost less than you think and is covered by most insurance
plans.
For information about ways you could save money on EPCLUSA, visit Financial
Assistance & Insurance Support or call 1-855-7-MYPATH (1-855-769-7284).
Please see Important Facts about EPCLUSA including Important Warning about hepatitis B reactivation on EPCLUSA.com.
How do I find out if my insurance covers EPCLUSA?
One way is by contacting EPCLUSA Support Path®, where a program navigator can assist you with this and other insurance-related questions. Call EPCLUSA Support Path at 1-855-7-MYPATH (1-855-769-7284) and inform the EPCLUSA Support Path program navigator that you want to complete a benefits investigation. Provide the EPCLUSA Support Path program navigator with your name and address, the name and address of your prescribing doctor, your pharmacy benefit card, and your medical benefit card. You may also contact your insurance company directly.
What if my insurance doesn’t cover EPCLUSA?
You still might be eligible for financial assistance. Visit Financial Assistance & Insurance Support or speak with an EPCLUSA Support Path® program navigator at 1-855-7-MYPATH (1-855-769-7284) to see what options might be available to you.
How long will it take to receive verification of my benefits from EPCLUSA Support Path®?
If you or your healthcare provider have contacted EPCLUSA Support Path and requested verification of your insurance coverage, you will receive verification of your benefits in a follow-up phone call from EPCLUSA Support Path within 24–48 hours. Your healthcare provider will receive a written benefit verification summary via fax within 48 hours.
How should I store EPCLUSA?
-
Store EPCLUSA at room temperature below 86 °F (30 °C)
-
Keep EPCLUSA in its original container
-
Do not use EPCLUSA if the seal over the bottle opening is broken or missing
Keep EPCLUSA and all medicines out of the reach of children.
How can I avoid getting Hep C again?
Hep C is mainly spread through blood-to-blood contact. Sharing needles or drug equipment, having sex with someone who has Hep C, or using unsanitary tattoo equipment are all activities that may increase your risk of getting Hep C again.
