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

INDICATION: BARACLUDE (entecavir) is a prescription medicine used for chronic infection with hepatitis B virus (HBV) in adults where the virus is multiplying and damaging the liver.

IMPORTANT SAFETY INFORMATION:

Tell your healthcare provider right away if you have any side effects or conditions, including the following:


• Worsening of your HBV infection if you stop taking BARACLUDE: Your hepatitis B symptoms may get worse or become very serious if you stop taking BARACLUDE. Your healthcare provider will need to follow you and do blood tests to check your liver if you stop taking BARACLUDE. Do not stop taking BARACLUDE without talking to your healthcare provider.



• If you have or get HIV infection (the virus that can cause AIDS): If you are taking BARACLUDE to treat chronic hepatitis B and are not taking medicines for your HIV at the same time, some HIV treatments that you take in the future may be less likely to work. You are advised to get an HIV test before you start taking BARACLUDE and anytime after that when there is a chance you were exposed to HIV. BARACLUDE will not help your HIV infection.



• Feeling very weak or tired, unusual muscle pain, trouble breathing, stomach pain with nausea and vomiting, feeling cold (especially in your arms and legs), feeling dizzy or lightheaded, or a fast or irregular heartbeat may be signs of a serious condition called lactic acidosis (buildup of an acid in the blood). Lactic acidosis is a medical emergency and must be treated in the hospital. This has happened in some people taking medicines like BARACLUDE.



• Your skin or the white part of your eyes turning yellow (jaundice), your urine turning dark, your bowel movements (stools) turning light in color, not feeling like eating food for several days or longer, feeling sick to your stomach (nausea), or having lower stomach pain may be signs of serious liver problems called hepatotoxicity. This may occur with liver enlargement (hepatomegaly) and fat in the liver (steatosis). This has happened in some people taking medicines like BARACLUDE.

BARACLUDE does not cure HBV or stop you from spreading HBV to others.

Do not take BARACLUDE if you are allergic to any of its ingredients. BARACLUDE has not been studied in children and is not recommended for anyone less than 16 years old.

Tell your healthcare provider right away if you have any conditions, including the following:

• If you have kidney problems: Because BARACLUDE is removed from your body through the kidneys, you may need a lower dose or a different dose schedule. Your healthcare provider may want to do tests to see if you need a lower dose or should take BARACLUDE less often than once a day.
• If you are pregnant or planning to become pregnant: It is not known if BARACLUDE is safe to use during pregnancy. It is not known if BARACLUDE helps to prevent a pregnant mother from passing HBV to her baby. You and your healthcare provider will need to decide if BARACLUDE is right for you. Do not breast-feed if you are taking BARACLUDE.

Discuss with your healthcare provider all prescription and non-prescription medicines, vitamins, herbal supplements, and other health preparations you are taking or plan to take. BARACLUDE may interact with medicines that leave the body through the kidneys.

If you are a liver transplant recipient, the safety and effectiveness of BARACLUDE are unknown. You must be carefully monitored before and during treatment with BARACLUDE. Talk with your doctor.

The most common side effects of BARACLUDE in clinical studies were headache, tiredness, dizziness, and nausea. This list of side effects is not complete at this time because BARACLUDE is still under study. Report any new or continuing symptom to your healthcare provider.

You should take BARACLUDE exactly as prescribed and on an empty stomach (at least 2 hours after a meal and at least 2 hours before the next meal).

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.

BARACLUDE is a registered trademark of Bristol-Myers Squibb Company.
© 2008 Bristol-Myers Squibb Company Princeton, NJ 08543 U.S.A
Legal Policy    Privacy Policy    Use of Cookies   Unsubscribe

686US08WA09301 12/07

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