• IMPORTANT SAFETY INFORMATION
  • IMPORTANT FACTS
  • FOR HEALTHCARE PROFESSIONALS
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    • TIẾNG VIỆT

[VEM-lih-dee]

  • English
  • 繁體中文
  • TIẾNG VIỆT

CHRONIC HEP B AND THE LIVER

INDICATION AND IMPORTANT SAFETY INFORMATION

HBV virus icons HBV virus icons

WHAT IS HEP B?

Chronic hepatitis B (hep B) is caused by a long-term infection of the hepatitis B virus (HBV). Over time, it can lead to serious liver damage.

WHAT DOES THE LIVER DO?

The liver is one of the most important organs in the body.
You cannot survive without your liver because it has many important jobs.

Some things your liver does are:

  • Fight off infection

  • Help digest food

  • Store energy
    and nutrients

  • Remove harmful
    chemicals from
    your blood

HOW HEP B AFFECTS THE LIVER

When there is a high amount of HBV in your body, it can cause
serious damage to cells in your liver.

Chronic hep B can lead to:

  • —  —  —  —  —

    Inflammation

  • —  —  —  —  —

    Fibrosis

  • —  —  —  —  —

    Cirrhosis

  • Liver cancer

WHAT ARE THE SYMPTOMS?

IMPORTANT SAFETY INFORMATION (continued)

If you feel any of the following hep B symptoms, do not ignore them and make sure to tell your doctor immediately. He or she will do tests to see if it is hep B-related.

Symptoms of a hep B infection may include:

  • Tiredness/
    fatigue

  • Joint pain

  • Stomach pain

  • Fever

  • Nausea
    and vomiting

  • Loss of appetite

  • Jaundice
    (yellowish eyes and skin)

  • Light-colored
    stools/dark urine

It's important to know that if you have chronic hep B, you may not experience any symptoms. Even if you don't feel any symptoms, the hep B virus is still in your body and may be harming your liver.

THE GOAL OF TREATMENT

IMPORTANT SAFETY INFORMATION (continued)

With hep B,
the amount of HBV
in your body (viral load)
can go up or down.

The higher your viral load,
the higher the risk
for you to develop
liver damage.

That's why it's important to visit your doctor regularly so he or she can monitor your liver health.

The goal of prescription medicine is to:

  • Decrease the amount
    of virus in the body

  • Reduce the risk
    of liver damage

If you are on treatment, there are tests that can tell how well your medicine is working. Talk to your doctor about why these tests are important and how to schedule them.

HISTORY OF CHRONIC HEP B TREATMENT

INDICATION AND IMPORTANT SAFETY INFORMATION

Timeline of FDA Approvals: Oral Antiviral Treatments for Chronic Hep B

  • 2016

    VEMLIDY®
    (tenofovir
    alafenamide)

  • 2008

    VIREAD®
    (tenofovir
    disoproxil
    fumarate)

  • 2006

    LdT
    (telbivudine)

  • 2005

    ETV
    (entecavir)

  • 2002

    ADV
    (adefovir
    dipivoxil)

  • 1998

    LAM
    (lamivudine)

This timeline is not intended to compare the efficacy or safety of the products listed above.

VEMLIDY is the first treatment for chronic hep B approved since VIREAD in 2008. Talk to your doctor to determine which treatment is right for you.

IMPORTANT SAFETY INFORMATION

Continued below
Continued below

INDICATION AND IMPORTANT SAFETY INFORMATION

What is VEMLIDY?

VEMLIDY is a prescription medicine used to treat chronic (long-lasting) hepatitis B virus (HBV) in adults with stable (compensated) liver disease.

  • VEMLIDY may lower the amount of HBV in your body.

  • VEMLIDY may improve the condition of your liver.

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

VEMLIDY can cause serious side effects, including:

  • Worsening of hepatitis B infection. Your hepatitis B (HBV) infection may become worse (flare-up) if you take VEMLIDY and then stop taking it. A “flare-up” is when your HBV infection suddenly returns in a worse way than before. Do not stop taking VEMLIDY without first talking to your healthcare provider, as they will need to monitor your health regularly to check your HBV infection.

What should I tell my healthcare provider before taking VEMLIDY?

All of your medical conditions, including if you have end stage renal disease (ESRD) or HIV-1 infection. Your healthcare provider may test you for HIV infection before starting VEMLIDY. If you have HIV and take VEMLIDY, the HIV virus may develop resistance and become harder to treat.

If you are pregnant or plan to become pregnant. It is not known if VEMLIDY will harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with VEMLIDY.

If you are breastfeeding or plan to breastfeed. It is not known if VEMLIDY passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how VEMLIDY works. Keep a list of all your medicines and show it to your healthcare provider and pharmacist. Do not start a new medicine without telling your healthcare provider. Ask your healthcare provider if it is safe to take VEMLIDY with all of your other medicines.

What are the possible side effects of VEMLIDY?

  • New or worse kidney problems, including kidney failure. Your healthcare provider may do blood and urine tests to check your kidneys when starting and during treatment with VEMLIDY. Your healthcare provider may tell you to stop taking VEMLIDY if you develop new or worse kidney problems.

  • Too much lactic acid in your blood (lactic acidosis), which is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feeling dizzy or lightheaded, or a fast or abnormal heartbeat.

  • Severe liver problems, which in rare cases can lead to death. Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark “tea-colored” urine, light-colored stools, loss of appetite for several days or longer, nausea, or stomach-area pain.

The most common side effect of VEMLIDY is headache.

These are not all the possible side effects of VEMLIDY. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Please see Important Facts about VEMLIDY, including important warnings.

Tap for Important Safety Information, including important warnings on worsening of hepatitis B infection.

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