INDICATION and IMPORTANT SAFETY INFORMATION about BARACLUDE® (entecavir)
INDICATION: BARACLUDE (entecavir) is a prescription medicine used
to treat chronic hepatitis B virus (HBV) in adults who have active virus and liver
- 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
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 (entecavir), 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
- 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
- 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.