Baraclude is an antiviral medication. Entecavir prevents certain virus cells from multiplying in your body.

Baraclude is an antiviral medicine that is used to treat chronic hepatitis B virus (HBV) in adults and children who are at least 2 years old and weigh at least 22 pounds (10 kilograms).

Baraclude is not a cure for hepatitis. It is not known whether this medicine will prevent cirrhosis or liver cancer.

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

Hepatitis B may become active or get worse after you stop using entecavir. You may need frequent liver function tests for several months.

Take Baraclude exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take Baraclude on an empty stomach, at least 2 hours before or 2 hours after eating.

Measure liquid medicine carefully, using the dosing syringe with your medicine (not a kitchen spoon). Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Entecavir doses are based on weight (especially in children and teenagers). Your dose needs may change if you gain or lose weight.

Use Baraclude regularly to get the most benefit and to keep your condition from getting worse. Call your doctor if your hepatitis symptoms do not improve, or if they get worse.

Do not change your dose or dosing schedule without your doctor's advice. Every person with HBV should remain under the care of a doctor.

Store Baraclude 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 Baraclude oral liquid after the expiration date on the label has passed.

Hepatitis B may become active or get worse in the months after you stop using Baraclude. You may need frequent liver function tests while using this medicine and for several months after your last dose.

Usual Adult Dose of Baraclude for Chronic Hepatitis B:

Compensated Liver Disease:
-Nucleoside-inhibitor-therapy-naive: 0.5 mg orally once a day
-History of hepatitis B viremia while using lamivudine or known lamivudine or telbivudine resistance substitutions rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L: 1 mg orally once a day

Decompensated Liver Disease: 1 mg orally once a day

Use: For the treatment of chronic HBV infection in patients with evidence of active viral replication and either persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease

Usual Pediatric Dose of Baraclude for Chronic Hepatitis B:

2 to 15 years:
Therapy-naive:
10 to 11 kg: 0.15 mg orally once a day
Greater than 11 to 14 kg: 0.2 mg orally once a day
Greater than 14 to 17 kg: 0.25 mg orally once a day
Greater than 17 to 20 kg: 0.3 mg orally once a day
Greater than 20 to 23 kg: 0.35 mg orally once a day
Greater than 23 to 26 kg: 0.4 mg orally once a day
Greater than 26 to 30 kg: 0.45 mg orally once a day
Greater than 30 kg: 0.5 mg orally once a day

Lamivudine-experienced:
10 to 11 kg: 0.3 mg orally once a day
Greater than 11 to 14 kg: 0.4 mg orally once a day
Greater than 14 to 17 kg: 0.5 mg orally once a day
Greater than 17 to 20 kg: 0.6 mg orally once a day
Greater than 20 to 23 kg: 0.7 mg orally once a day
Greater than 23 to 26 kg: 0.8 mg orally once a day
Greater than 26 to 30 kg: 0.9 mg orally once a day
Greater than 30 kg: 1 mg orally once a day

Comments:
-The oral solution is recommended for patients up to 30 kg.

16 years or older:
Compensated Liver Disease:
-Nucleoside-inhibitor-therapy-naive: 0.5 mg orally once a day
-History of hepatitis B viremia while using lamivudine or known lamivudine or telbivudine resistance substitutions rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L: 1 mg orally once a day

Use: For the treatment of chronic HBV infection in patients with evidence of active viral replication and either persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease

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.

You may need to be tested for HIV before you start taking Baraclude. Taking medicine to treat chronic hepatitis B can cause HIV infection to become resistant to certain HIV and AIDS medications.

To make sure Baraclude is safe for you, tell your doctor if you have ever had:

• HIV or AIDS (or if you have been exposed to HIV);

• kidney disease;

• liver problems other than HBV;

• a liver transplant; or

• if you also take lamivudine (Epivir, Epzicom, Trizivir) or telbivudine (Tyzeka).

Tell your doctor about all medicines you have used to treat hepatitis B in the past. Baraclude may not be the right medication if you have used certain other medicines for HBV.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you are overweight, if you've taken antiviral medication for a long time, or if you are a woman. Ask your doctor about your risk.

It is not known whether entecavir will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

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 entecavir on the baby.

It may not be safe to breast-feed while using Baraclude. Ask your doctor about any risk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Using this medicine will not prevent your disease from spreading. 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.

Get emergency medical help if you have signs of an allergic reaction to Baraclude: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people using Baraclude develop lactic acidosis, which can be fatal. Get emergency medical help if you have even mild symptoms such as:

• unusual muscle pain;

• feeling cold;

• trouble breathing;

• feeling dizzy, light-headed, tired, or very weak;

• stomach pain, vomiting; or

• fast or irregular heartbeats.

Baraclude may also cause severe liver symptoms. Call your doctor at once if you have: swelling around your midsection, nausea, stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Baraclude side effects may include:

• nausea;

• dizziness, tired feeling; or

• headache.

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.

Other drugs may interact with entecavir, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.