Baraclude (entecavir) is an antiviral medication. Entecavir prevents certain virus cells from multiplying in your body
Baraclude is used to treat chronic hepatitis B virus (HBV) in adults and children who are at least 2 years old.
Baraclude is not a cure for hepatitis. It is not known whether this medicine will prevent cirrhosis or liver cancer.
Baraclude may also be used for other purposes not listed in this medication guide.
Important information
You should not take Baraclude if you have HIV (human immunodeficiency virus) that is not being treated.
Symptoms of hepatitis B can come back or get worse after you stop taking Baraclude. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.
This medicine may cause a serious condition called lactic acidosis. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.
Baraclude may also cause severe liver symptoms such as nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Call your doctor at once if you have any of these symptoms.
Some people with hepatitis B develop liver symptoms after they stop taking Baraclude, even months after stopping. Your doctor may want to check your liver function on a regular basis for several months after you stop using this medication. Do not miss any scheduled visits.
Before taking this medicine
You should not take Baraclude if you are allergic to entecavir, or if you also have HIV (human immunodeficiency virus) that is not being treated.
To make sure Baraclude is safe for you, tell your doctor if you have:
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HIV or AIDS;
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kidney disease;
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liver disease;
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if you also take lamivudine (Epivir, Epzicom, Trizivir) or telbivudine (Tyzeka); or
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if you have had a liver transplant.
Tell your doctor about all medicines you have used to treat hepatitis B in the past.
Tell your doctor if you have been exposed to HIV, or if you have untreated HIV or AIDS. Taking medicines to treat chronic hepatitis B can cause HIV infection to become resistant to certain HIV and AIDS medications. You may need to be tested for HIV before you start taking Baraclude.
Some people taking entecavir develop a serious condition called lactic acidosis. This may be more likely if you have liver or kidney disease, congestive heart failure, a severe infection, if you are dehydrated, or if you drink large amounts of alcohol. Talk with your doctor about your risk.
FDA pregnancy category C. It is not known whether Baraclude will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.
See also: Pregnancy and breastfeeding warnings (in more detail)
If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Baraclude on the baby.
It is not known whether entecavir passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
How should I take Baraclude?
Take Baraclude exactly as it was prescribed for you. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
You must remain under the care of a doctor while you are using Baraclude.
Tell your doctor if you have any changes in weight. Entecavir doses are based on weight (especially in children), and any changes may affect the dose.
Take Baraclude on an empty stomach, at least 2 hours before or 2 hours after eating.
This medicine comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Measure liquid medicine carefully, using the dosing spoon and instructions provided with your medicine. You must hold the spoon upright while pouring in the medicine and measuring the dose. Rinse the dosing spoon with water after each use. If you do not have an Baraclude dose-measuring spoon, ask your pharmacist for one.
Call your doctor if your hepatitis symptoms do not improve, or if they get worse while using Baraclude.
Symptoms of hepatitis B can come back or get worse after you stop taking Baraclude. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.
Use Baraclude regularly to get the most benefit and to keep your condition from getting worse. Get your prescription refilled before you run out of medicine completely.
Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.
Keep the bottle of oral liquid in its original carton. Throw away any unused oral liquid after the expiration date on the label has passed.
What happens if I miss a dose?
Baraclude dosing information
Usual Adult Dose for Chronic Hepatitis B:
Nucleoside treatment-naive: 0.5 mg orally once a day
Lamivudine-refractory, known lamivudine or telbivudine resistance mutations, or decompensated liver disease: 1 mg orally once a day
Usual Pediatric Dose for Chronic Hepatitis B:
16 years or older:
Nucleoside treatment-naive: 0.5 mg orally once a day
Lamivudine-refractory or known lamivudine or telbivudine resistance mutations: 1 mg orally once a day
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking Baraclude?
Taking this medicine will not prevent you from passing hepatitis B to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HBV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.
Baraclude side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Baraclude: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some people develop lactic acidosis while taking Baraclude. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as:
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muscle pain or weakness;
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numb or cold feeling in your arms and legs;
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trouble breathing;
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feeling dizzy, light-headed, tired, or very weak;
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stomach pain, nausea with vomiting; or
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fast or uneven heart rate.
Baraclude may also cause severe liver symptoms. Call your doctor at once if you have: nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common Baraclude side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
What other drugs will affect Baraclude?
Other drugs may interact with entecavir, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
