Before starting treatment

Things to consider before taking BARACLUDE^® (entecavir)

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 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.
• 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.

If you have or get HIV 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.

You should not take BARACLUDE if you:

• Are allergic to any of its ingredients, including the active ingredient in BARACLUDE, entecavir. Please see the Patient Information for a full list of ingredients.
• Are less than 16 years old. BARACLUDE has not been studied in children and is not recommended for anyone less than 16 years old.