Get the latest information about BARACLUDE and chronic hepatitis B, including information kits, updates, and more. LEARN MORE
Baraclude Co-pay Benefit Card

INDICATION and IMPORTANT SAFETY INFORMATION about BARACLUDE® (entecavir) Tablets:

INDICATION: BARACLUDE(entecavir) is a prescription medicine used to treat chronic hepatitis B virus (HBV) in adults who have active virus and liver damage.

  • Currently there is no cure for HBV. BARACLUDE will not cure HBV
  • BARACLUDE may:
    • lower the amount of HBV in the body
    • lower the ability of HBV to multiply and infect new liver cells
    • improve the condition of your liver
  • It is not known whether BARACLUDE will reduce the chances of getting liver cancer or liver damage (cirrhosis), which may be caused
    by chronic HBV infection
  • It is not known if BARACLUDE is safe and effective for use in children

IMPORTANT SAFETY INFORMATION:

What is the most important information I 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 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.

You should take BARACLUDE exactly as your healthcare provider tells you.

  • Take BARACLUDE on an empty stomach (at least 2 hours after a meal and at least 2 hours before the next meal).

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.

BARACLUDE (entecavir) is one of several treatments your doctor may consider.




bms
BARACLUDE® is a registered trademark of Bristol-Myers Squibb.
© 2009 Bristol-Myers Squibb Princeton, NJ 08543 U.S.A
Legal Policy    Privacy Policy    Use of Cookies   Unsubscribe

686US10WA16101 12/10

ppa
If you or someone you know needs help paying for medicine, click here.