Consumer Information for: BARACLUDE

Serious Warnings and Precautions

Does BARACLUDE lower the risk of passing HBV to others?
BARACLUDE does not stop you from spreading HBV to others by sex, sharing needles, or being exposed to your blood. Talk to your healthcare provider about safe sexual practices that protect your partner. Never share needles. Do not share personal items that can have blood or body fluids on them, like toothbrushes or razor blades. A shot (vaccine) is available to protect people at risk from becoming infected with HBV.

Severe worsening of hepatitis (liver inflammation) has occurred in patients who have stopped taking anti- hepatitis B therapy (including BARACLUDE). Your doctor will monitor your condition in this case and may resume therapy.

Lactic acidosis (increase in acid level of blood) and severe hepatomegaly with steatosis (enlarged fatty liver), including fatal cases have been reported in patients using nucleoside analogue medicines, including BARACLUDE, either alone or in combination. Reports of lactic acidosis with BARACLUDE often involved patients who were seriously ill due to their liver disease or other medical condition. Lactic acidosis is a medical emergency and must be treated in the hospital. Call your healthcare provider right away if you get any of the signs of lactic acidosis (see table Serious Side Effects and What to do About them).

Your hepatitis B infection may get worse or become very serious if you stop 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 will need to monitor your health and do regular blood tests to check your liver if you stop BARACLUDE. Tell your healthcare provider right away about any new or unusual symptoms that you notice after you stop taking BARACLUDE.

If you have or get HIV (human immunodeficiency virus) infection be sure to discuss your treatment with your doctor. 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.

BEFORE you use BARACLUDE talk to your healthcare provider about all of your medical conditions, including if you:

• have had a liver transplant.
• have kidney problems. Your doctor may need to adjust your BARACLUDE dose or dose schedule.
• are pregnant or planning to become pregnant. It is not known if BARACLUDE is safe to use during pregnancy. It is not known whether BARACLUDE helps 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. If you use BARACLUDE while you are pregnant, talk to your healthcare provider about the BARACLUDE Pregnancy Registry.
• are breast-feeding. It is not known if BARACLUDE can pass into your breast milk or if it can harm your baby. Do not breast-feed if you are taking BARACLUDE.
• are lactose intolerant. BARACLUDE tablets contain lactose. If you have been told that you have intolerance to some sugars, contact your doctor before taking this medicine.

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

BARACLUDE may interact with other medicines that leave the body through the kidneys.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist.