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Now that I have more information about chronic hepatitis B, I can better understand my condition.*

Please see Indication and Important Safety Information below, including Boxed WARNINGS.

Not an actual patient.

Not an actual patient quote.

Now that I have more information about chronic hepatitis B, I can better understand my condition.*

Please see Indication and Important Safety Information below, including Boxed WARNINGS.

Not an actual patient.

Not an actual patient quote.

 

Frequently asked questions

Chronic hepatitis B FAQs
BARACLUDE FAQs

BARACLUDE FAQs

Q. What is BARACLUDE?

A. BARACLUDE® (entecavir) is a prescription medicine used to treat chronic hepatitis B virus (HBV) A type of virus that infects the liver, and may damage it over time. The virus can be transmitted from mother to child during childbirth. It can also be spread through unprotected sex, IV drug use, needle sharing, and contact with infected blood, semen, vaginal, and other bodily fluids. in adults and children 2 years of age and older who have active liver The largest internal organ in the body. The liver performs many important tasks to keep the body healthy. It removes harmful toxins from the blood and helps digest food by turning it into energy and nutrients the body can use. disease.

BARACLUDE is one of several treatment options for chronic hepatitis B your doctor may consider. Back to top

A. BARACLUDE works to fight the hepatitis B virus so there is less of it in your blood, and it may give your liver a chance to improve. It is not known whether BARACLUDE will reduce your chances of getting liver cancer or liver damage (cirrhosis), which may be caused by chronic HBV infection. Learn more.

There is currently no cure for chronic HBV infection. BARACLUDE will not cure HBV or stop you from spreading HBV to others. Back to top

A. If you are an adult or child greater than 2 years of age who has chronic hepatitis B where the virus is multiplying and damaging the liver, you may benefit from BARACLUDE. Only your doctor can decide if you need treatment for chronic hepatitis B and if BARACLUDE is right for you. Keep in mind that BARACLUDE is one of several treatment options your doctor may consider.
Click here to read Important Safety Information about BARACLUDE, including Boxed WARNINGS about the worsening of hepatitis B virus infection if you stop taking BARACLUDE and monitoring of your health, the development of resistance to certain HIV medicines in those with untreated HIV, buildup of acid in the blood and serious liver problems that can cause death in some people who have taken BARACLUDE or medicines like BARACLUDE, below. 
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A. You should take BARACLUDE by mouth. Take BARACLUDE exactly as your healthcare provider tells you to. Take BARACLUDE on an empty stomach, at least 2 hours after a meal and at least 2 hours before the next meal. To help you remember to take your BARACLUDE, try to take it at the same time every day. Your hepatitis B virus infection may get worse if you stop taking BARACLUDE. This usually happens within 6 months after stopping BARACLUDE. Do not run out of or stop taking BARACLUDE without talking to your healthcare provider. Your healthcare provider should monitor your health and do regular blood tests to check your liver if you stop taking BARACLUDE. Learn more. Back to top

A. Below is the most important information you should know about BARACLUDE:

  • Your hepatitis B virus infection may get worse if you stop taking BARACLUDE. This usually happens within 6 months after stopping BARACLUDE.
    • Take BARACLUDE exactly as prescribed.
    • Do not run out of BARACLUDE.
    • Do not stop BARACLUDE without talking to your healthcare provider.
    • Your healthcare provider should monitor your health and do regular blood tests to check your liver if you stop taking BARACLUDE.
  • If you have or get HIV infection that is not being treated with medicines while taking BARACLUDE, the HIV virus may develop resistance to certain HIV medicines and become harder to treat. You should get an HIV test before you start taking BARACLUDE and anytime after that when there is a chance you were exposed to HIV.

BARACLUDE (entecavir) can cause serious side effects including:

  • Lactic acidosis (buildup of acid in the blood). Some people who have taken BARACLUDE or medicines like BARACLUDE (a nucleoside analogue) have developed a serious condition called lactic acidosis. Lactic acidosis is a serious medical emergency that can cause death. Lactic acidosis must be treated in the hospital. Reports of lactic acidosis with BARACLUDE generally involved patients who were seriously ill due to their liver disease or other medical condition.

    Call your healthcare provider right away if you get any of the following signs or symptoms of lactic acidosis:

    • You feel very weak or tired.
    • You have unusual (not normal) muscle pain.
    • You have trouble breathing.
    • You have stomach pain with nausea and vomiting.
    • You feel cold, especially in your arms and legs.
    • You feel dizzy or light-headed.
    • You have a fast or irregular heartbeat.
  • Serious liver problems. Some people who have taken medicines like BARACLUDE have developed serious liver problems called hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Hepatomegaly with steatosis is a serious medical emergency that can cause death.

    Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems:

    • Your skin or the white part of your eyes turns yellow (jaundice).
    • Your urine turns dark.
    • Your bowel movements (stools) turn light in color.
    • You don't feel like eating food for several days or longer.
    • You feel sick to your stomach (nausea).
    • You have lower stomach pain.

You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight, or have been taking nucleoside analogue medicines, like BARACLUDE for a long time.

The most common side effects of BARACLUDE® (entecavir) include headache, tiredness, dizziness, and nausea. Be sure to stay under your doctor's care and watch for any changes in your health that may occur while you are taking BARACLUDE, or after you stop BARACLUDE.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at
1-800-FDA-1088.

Learn more about these and other possible side effects of BARACLUDE, plus more important information you should know about this medicine. Back to top

A. Before you take BARACLUDE, tell your healthcare provider if you have kidney problems. Your BARACLUDE dose or schedule may need to be changed. Also tell your healthcare provider if you have received medicine for HBV before. Some people, especially those who have already been treated with certain other medicines for HBV infection, may develop resistance to BARACLUDE. These people may have less benefit from treatment with BARACLUDE and may have worsening of hepatitis after resistant virus appears. Your healthcare provider will test the level of the hepatitis B virus in your blood regularly. Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Learn more. Back to top

A. Yes. Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some herbal medicines may interfere with prescription medications. Back to top

Chronic hepatitis B FAQs

A. Hepatitis B A liver infection caused by the hepatitis B virus (HBV). It is spread primarily through infected blood and bodily fluids, unprotected sex, shared needles, and from infected mother's blood to her baby during birth. is a serious liver The largest internal organ in the body. The liver performs many important tasks to keep the body healthy. It removes harmful toxins from the blood and helps digest food by turning it into energy and nutrients the body can use. infection that affects nearly two billion people around the world. It is caused by a type of virus A tiny microorganism that invades living cells and may cause diseases. that infects and multiplies in the liver. Hepatitis B is infectious. If it remains in your blood for more than 6 months, it is considered to be chronic hepatitis B (CHB). Many people with hepatitis B don't exhibit any symptoms, so the disease is commonly referred to as the "silent" disease. Yet hepatitis B is, in fact, a serious condition. In some people, chronic hepatitis B infection may lead to severe liver damage. Learn more. Back to top

A. Anyone who comes into contact with hepatitis B virus-contaminated blood or bodily fluids is at risk. However, some people are at increased risk due to occupation or close contact. These include babies born to infected mothers, people with more than one sex partner, anyone who has ever shared needles to inject drugs, and healthcare workers at risk of exposure to contaminated materials, among others. In addition, people from areas where hepatitis B is widely prevalent, including Asians and Pacific Islanders, have a higher infection rate of hepatitis B virus. Learn more. Back to top

A. Experts recommend that anyone who may be at high risk for hepatitis B virus infection should be tested. Screening recommendations also include men who have sex with men, anyone who has ever shared needles to inject drugs, dialysis patients, people infected with HIV, pregnant women, and family members, household members, and sexual partners of those infected with HBV. And since chronic hepatitis B is common among Asians and Pacific Islanders, members of these communities should also consider screening. Back to top

A. People may be chronically infected for years without having symptoms. That's why it's often called a "silent" disease. But even if you have no symptoms, remember, the hepatitis B virus can still be damaging your liver. You should see your doctor regularly to monitor your health.

While some people often do not experience symptoms from chronic hepatitis B, some may have ongoing symptoms similar to that seen in some cases of acute hepatitis B, such as:

  • Fever
  • Tiredness
  • Joint or muscle pain
  • Loss of appetite
  • Mild nausea and vomiting
Learn more. Back to top

A. Yes. Oftentimes, people with chronic hepatitis B do not exhibit any symptoms. If the hepatitis B virus is multiplying in your liver, you could develop liver damage without knowing it. See your doctor regularly to monitor your health and help keep your condition from getting worse. Learn More. Back to top

A. Sometimes people with chronic hepatitis B are referred to as "carriers." "Carriers" can still spread hepatitis B virus to others, even if they feel fine. If you're a "carrier," you should monitor your condition closely with your doctor, since your infection can get worse at any time. You should also take proper precautions to avoid infecting others. Get tips for protecting others. Back to top

A. A blood test called the hepatitis B blood panel A three-part blood test that helps your doctor diagnose hepatitis B. This test is made up of the following:
The hepatitis B surface antigen (HBsAg). If positive, then hepatitis B virus is in your body. The hepatitis B surface antibody (HBsAb) test reveals whether or not your body has developed a protective antibody against the hepatitis B virus. Surface antibodies can form if you have been vaccinated, or if you have recovered from a hepatitis B infection. This usually provides long-term protection against future hepatitis B infection. The hepatitis B core antibody (HBcAb) test reveals if you have been exposed to the virus. This antibody does not protect you from the hepatitis B virus.
can tell your doctor if you have the hepatitis B virus.

Ask your doctor to explain each test result to you. You can also download the free Treatment Tracker, which answers important questions about the tests your doctor may perform.

If you test positive for hepatitis B, your doctor will probably ask you to come back in 6 months to get tested again. If, at that time, you still test positive for hepatitis B, you most likely have a chronic infection. Learn More. Back to top

A. Right now, there is no cure for chronic hepatitis B. But there are treatments that may reduce the amount of hepatitis B virus (HBV) in the body and may help improve your liver's condition. BARACLUDE is one option your doctor may consider. If you have chronic hepatitis B, be sure you see your doctor regularly — even if you're on treatment. Ongoing monitoring of HBV and its impact on your liver are important to your health. Back to top

A. It's important to make sure anyone living in your home goes to their doctor for hepatitis B testing. If they test negative, they should get vaccinated, but remember that vaccination won't help anyone who has already been infected. You should try to make sure that no one comes in contact with your blood and bodily fluids. Back to top

A. Yes. If you are pregnant or plan to become pregnant tell your doctor that you are infected. Steps can be taken to manage and reduce the chance of transmission during delivery. Infants born to HBV-infected mothers should be given
Hepatitis B Immune Globulin (HBIG) A medication given after a person has been exposed to potentially HBV-infected blood or infected bodily fluids, which can include: contact with blood, shared needles, infants born to infected women, and through sexual contact or close household contact with an infected person. HBIG is often used as a post-liver transplant treatment. and the first course of HBV vaccine within 12 hours of birth. Back to top

A. Only your doctor can decide if you need to be on treatment for chronic hepatitis B. Your doctor will base his or her decision on a number of factors including your health, your liver's health, your family history, and your viral load The amount of virus in the blood. The viral load is measured through a simple blood test. . Not everyone who has chronic hepatitis B needs treatment. Regular visits will help your doctor monitor your condition and make the best decision for your health. Learn more. Back to top

A. Be sure to follow up with your doctor as often as your doctor recommends. This will help your doctor monitor your condition and decide how to best manage your disease. Learn More. Back to top

A. There are many steps you can take to help protect your liver. Do not smoke or drink alcohol. Both can be very harmful to a liver infected with chronic hepatitis B. You should also have a healthy diet. Rest, reduce stress, and ask your doctor if exercising is appropriate. Back to top

Starter Brochure

Read “Getting Started,” a helpful guide for patients taking BARACLUDE®.

CLICK to download brochure.

Treatment Tracker

Record and track your lab test results to help you and your doctor manage your chronic hepatitis B.

CLICK to download tracker brochure.

Important Safety Information:

Selected Important Safety Information

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What is the most important information I should know about BARACLUDE® (entecavir)?

  •   Your hepatitis B virus infection may get worse if you stop taking BARACLUDE. This usually happens within 6 months after stopping BARACLUDE. Take BARACLUDE exactly as prescribed; do not run out of your medicine or stop taking BARACLUDE without talking to your healthcare provider. Your healthcare provider should monitor your health and do regular blood tests to check your liver if you stop taking BARACLUDE.
  •   If you have or get HIV infection that is not being treated with medicines while taking BARACLUDE, the HIV virus may develop resistance to certain HIV medicines and become harder to treat. You should get an HIV test before you start taking BARACLUDE and anytime after that when there is a chance you were exposed to HIV.

BARACLUDE can cause serious side effects including:

  •   Lactic acidosis (buildup of acid in the blood). Some people who have taken BARACLUDE or medicines like BARACLUDE have developed a serious condition called lactic acidosis. Lactic acidosis is a serious medical emergency that can cause death and must be treated in the hospital. Reports of lactic acidosis with BARACLUDE generally involved patients who were seriously ill due to their liver disease or other medical condition.
    •   Call your healthcare provider right away if you: feel very weak or tired; have unusual (not normal) muscle pain; have trouble breathing; have stomach pain with nausea and vomiting; feel cold (especially in your arms and legs); feel dizzy or light-headed; have a fast or irregular heartbeat.
  •   Serious liver problems. Some people who have taken medicines like BARACLUDE have developed serious liver problems called hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Hepatomegaly with steatosis is a serious medical emergency that can cause death.
    •   Call your healthcare provider right away if: your skin or the white part of your eyes turns yellow (jaundice); your urine turns dark; your bowel movements (stools) turn light in color; you don’t feel like eating food for several days or longer; you feel sick to your stomach (nausea); you have lower stomach pain.
  •   If you are female, very overweight, or have been taking nucleoside analogue medicines, like BARACLUDE for a long time, you may be more likely to get lactic acidosis or serious liver problems.

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

  •   have kidney problems. Your BARACLUDE dose or schedule may need to be changed.
  •   have received medicine for HBV before. Some people, especially those who have already been treated with certain other medicines for HBV, may develop resistance to BARACLUDE and may have less benefit from treatment. Your healthcare provider will test the level of the hepatitis B virus in your blood.
  •   have any other medical conditions.
  •   are pregnant or plan to become pregnant. It is not known if BARACLUDE will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
  •   are breast-feeding or plan to breast-feed. It is not known if BARACLUDE can pass into your breast milk. You and your healthcare provider should decide if you will take BARACLUDE or breast-feed.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

The most common side effects of BARACLUDE include: headache, tiredness, dizziness, and nausea. These are not all the possible side effects of BARACLUDE. For more information, ask your healthcare provider or pharmacist.

Do not change your dose or stop taking BARACLUDE without talking to your healthcare provider. If you forget to take your dose, call your healthcare provider or pharmacist, if you are not sure what to do.

Please see Full Prescribing Information, including “What is the most important information I should know about BARACLUDE?” in the Patient Information section. 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.

Selected Important Safety Information:

Expand

Selected Important Safety Information

  •   have received medicine for HBV before. Some people, especially those who have already been treated with certain other medicines for HBV, may develop resistance to BARACLUDE and may have less benefit from treatment. Your healthcare provider will test the level of the hepatitis B virus in your blood.
  •   have any other medical conditions.
  •   are pregnant or plan to become pregnant. It is not known if BARACLUDE will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
  •   are breast-feeding or plan to breast-feed. It is not known if BARACLUDE can pass into your breast milk. You and your healthcare provider should decide if you will take BARACLUDE or breast-feed.