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EPCLUSA ACCESS- velpatasvir and sofosbuvir tablet, film coated


  1. Patient Information
  2. Inform Patients That Hbv Reactivation Can Occur In Patients Coinfected With Hbv During Or After Treatment Of Hcv Infection. Advise Patients To Tell Their Healthcare Provider If They Have A History Of Hbv Infection[epclusa Can Cause Serious Side Effects, Including,hepatitis B Virus Reactivation:
  3. Before Taking Epclusa, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You:
  4. How Should I Take Epclusa?
  5. Epclusa Can Cause Serious Side Effects, Including:
  6. Active Ingredients:
  7. Inactive Ingredients:

Patient Information 

Advise the patient to read the approved patient labeling (Patient Information).

Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV

Inform Patients That Hbv Reactivation Can Occur In Patients Coinfected With Hbv During Or After Treatment Of Hcv Infection. Advise Patients To Tell Their Healthcare Provider If They Have A History Of Hbv Infection[epclusa Can Cause Serious Side Effects, Including,hepatitis B Virus Reactivation: 

Before starting treatment with EPCLUSA, your healthcare provider will do blood tests to check for hepatitis B virus infection. If you have ever had hepatitis B virus infection, the hepatitis B virus could become active again during or after treatment of hepatitis C virus with EPCLUSA. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure and death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop taking EPCLUSA.
For more information about side effects,

  • EPCLUSA is a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection:
    • without cirrhosis or with compensated cirrhosis
    • with advanced cirrhosis (decompensated) in combination with ribavirin

It is not known if EPCLUSA is safe and effective in children under 18 years of age.

Before Taking Epclusa, 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
  • have severe kidney problems or you are on dialysis
  • have HIV-1 infection
  • are pregnant or plan to become pregnant. It is not known if EPCLUSA will harm your unborn baby.
    • Females who take EPCLUSA in combination with ribavirin should avoid becoming pregnant during treatment and for 6 months after stopping treatment. Call your healthcare provider right away if you think you may be pregnant or become pregnant during treatment with EPCLUSA in combination with ribavirin.
    • Males and females who take EPCLUSA in combination with ribavirin should also read the ribavirin Medication Guide for important pregnancy, contraception, and infertility information.
  • are breastfeeding or plan to breastfeed. It is not known if EPCLUSA passes into your breast milk.
    • Talk to your healthcare provider about the best way to feed your baby during treatment with EPCLUSA.

Tell your healthcare provider about all of the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements. EPCLUSA and other medicines may affect each other. This can cause you to have too much or not enough EPCLUSA or other medicines in your body. This may affect the way EPCLUSA or your other medicines work, or may cause side effects.

Keep a list of your medicines to show your healthcare provider and pharmacist.

  • You can ask your healthcare provider or pharmacist for a list of medicines that interact with EPCLUSA.

Do not start taking a new medicine without telling your healthcare provider.Your healthcare provider can tell you if it is safe to take EPCLUSA with other medicines.

How Should I Take Epclusa? 

  • Take EPCLUSA exactly as your healthcare provider tells you to take it. Do not change your dose unless your healthcare provider tells you to.
  • Do not stop taking EPCLUSA without first talking with your healthcare provider.
  • Take 1 EPCLUSA tablet each day.
  • Take EPCLUSA with or without food.
  • It is important that you do not 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.

Epclusa Can Cause Serious Side Effects, Including: 

  • Hepatitis B virus reactivation.

    • Store EPCLUSA below 30 C (86 F).
    • 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.

    General information about the safe and effective use of EPCLUSA

    Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use EPCLUSA for a condition for which it was not prescribed. Do not give EPCLUSA to other people, even if they have the same symptoms you have. It may harm them.

    You can ask your healthcare provider or pharmacist for information about EPCLUSA that is written for health professionals.

Active Ingredients: 

sofosbuvir and velpatasvir

Inactive Ingredients: 

copovidone, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose.

The tablet film-coat contains: iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Manufactured and distributed by:
Gilead Sciences, Inc., Foster City, CA 94404

EPCLUSA is a trademark of Gilead Sciences, Inc., or its related companies. All other trademarks referenced herein are the property of their respective owners.

2017 Gilead Sciences, Inc. All rights reserved.

For more information, go to www.epclusa.com.

208341-GS-004A



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