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VIREAD for the Treatment of
Chronic Hepatitis B (CHB)

Welcome to VIREAD.com (VEER ee ad). This website will tell you about VIREAD (tenofovir disoproxil fumarate), a medicine used to treat chronic hepatitis B in people 12 years of age and older. VIREAD will not cure HBV. VIREAD may help lower the amount of hepatitis B virus in your body by lowering the ability of the virus to multiply.1 VIREAD may improve the condition of your liver. The long-term effects of taking VIREAD for treatment of chronic hepatitis B infection are not known.1 It is also not known if VIREAD is safe and effective for treatment of chronic hepatitis B in children under the age of 12 years.

VIREAD does not reduce the risk of passing the hepatitis B virus to others.

For adults and children 12 years of age and older, the usual dose of VIREAD is one 300 mg tablet each day. If you are an adult and have kidney problems, your doctor may recommend that you take VIREAD less often.1

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about VIREAD?

VIREAD can cause serious side effects, including:

1. Build-up of an acid in your blood (lactic acidosis). Lactic acidosis can happen in some people who take VIREAD. Lactic acidosis is a serious medical emergency that can lead to death. Lactic acidosis can be hard to identify early, because the symptoms could seem like symptoms of other health problems. Call your healthcare provider right away if you get the following symptoms which could be signs of lactic acidosis:

  • feeling very weak or tired
  • have unusual (not normal) muscle pain
  • have trouble breathing
  • have stomach pain with
    • nausea (feel sick to your stomach)
    • vomiting
  • feel cold, especially in your arms and legs
  • feel dizzy or lightheaded
  • have a fast or irregular heartbeat

2. Severe liver problems. Severe liver problems can happen in people who take VIREAD or similar medicines. In some cases these liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis) when you take VIREAD. Call your healthcare provider right away if you have any of the following symptoms of liver problems:

  • your skin or the white part of your eyes turns yellow (jaundice).
  • dark “tea-colored” urine
  • light-colored bowel movements (stools)
  • loss of appetite for several days or longer
  • nausea
  • stomach pain

You may be more likely to get lactic acidosis or severe liver problems if you are female, very overweight (obese), or have been taking VIREAD for a long time.

3. Worsening of your Hepatitis B infection. Your hepatitis B Virus (HBV) infection may become worse (flare-up) if you take VIREAD and then stop it. A "flare-up" is when your HBV infection suddenly returns in a worse way than before.

  • Do not let your VIREAD run out. Refill your prescription or talk to your healthcare provider before your VIREAD is all gone.
  • Do not stop taking VIREAD without first talking to your healthcare provider.
  • If you stop taking VIREAD, your healthcare provider will need to check your health often and do blood tests regularly to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking VIREAD.

4. Talk to your doctor about taking an HIV test before starting treatment with VIREAD for chronic hepatitis B.

What should I tell my healthcare provider before taking VIREAD?

Before you take VIREAD, tell your healthcare provider if you:

  • have liver problems, including hepatitis B (HBV) infection.
  • have kidney problems.
  • have bone problems.
  • have any other medical conditions, including HIV infection.
  • are pregnant or plan to become pregnant. It is not known if VIREAD will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. Do not breastfeed if you are taking VIREAD. Tenofovir passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. VIREAD may affect the way other medicines work, and other medicines may affect how VIREAD works.

Do not take VIREAD if you also take:

  • other medicines that contain tenofovir (ATRIPLA®, COMPLERA®, STRIBILD®, TRUVADA®)
  • adefovir (HEPSERA®)

Especially tell your healthcare provider if you take the following medications:

  • didanosine (VIDEX, VIDEX EC)
  • atazanavir (REYATAZ)
  • darunavir (PREZISTA)
  • lopinavir with ritonavir (KALETRA)

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How should I take VIREAD?

  • See “What is the most important information I should know about VIREAD?”
  • Take VIREAD exactly as your healthcare provider tells you to take it.
  • Take VIREAD at the same time every day.
  • For adults and children 12 years of age and older, the usual dose of VIREAD is one 300 mg tablet each day.
  • If you are an adult with kidney problems, your healthcare provider may tell you to take VIREAD less often.
  • Take VIREAD tablets by mouth, with or without food.
  • Do not miss a dose of VIREAD. If you miss a dose of VIREAD, take the missed dose as soon as you remember. If it is almost time for your next dose of VIREAD, do not take the missed dose. Take the next dose of VIREAD at your regular time.
  • If you take too much VIREAD, call your local poison control center or go right away to the nearest hospital emergency room.

What are the possible side effects of VIREAD?

VIREAD may cause serious side effects, including:

  • See “What is the most important information I should know about VIREAD?”
  • New or worse kidney problems, including kidney failure, can happen in some people who take VIREAD. Your healthcare provider should do blood tests to check your kidneys before you start treatment with VIREAD. If you have had kidney problems in the past or need to take another medicine that can cause kidney problems, your healthcare provider may need to do blood tests to check your kidneys during your treatment with VIREAD.
  • Bone problems can happen in some people who take VIREAD. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do additional tests to check your bones.

The most common side effects in all people who take VIREAD are:

  • nausea
  • rash
  • diarrhea
  • headache
  • pain
  • depression
  • weakness

In some people with advanced HBV-infection, other common side effects may include:

  • sleeping problems
  • itching
  • vomiting
  • dizziness
  • fever

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of VIREAD. For more information, ask your healthcare provider or pharmacist.

Please see full Prescribing Information including Patient Information with important warnings.

Reference:

  1. VIREAD (tenofovir disoproxil fumarate) Prescribing Information. Foster City, CA: Gilead Sciences, Inc.; November 2012.