Brand Names: Baraclude

Generic Name: entecavir (Pronunciation: en TEK a vir)

• What is entecavir (Baraclude)?
• What are the possible side effects of entecavir (Baraclude)?
• What is the most important information I should know about entecavir (Baraclude)?
• What should I discuss with my healthcare provider before taking entecavir (Baraclude)?
• How should I take entecavir (Baraclude)?
• What happens if I miss a dose (Baraclude)?
• What happens if I overdose (Baraclude)?
• What should I avoid while taking entecavir (Baraclude)?
• What other drugs will affect entecavir (Baraclude)?
• Where can I get more information?

What is entecavir (Baraclude)?

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

Entecavir is used to treat chronic hepatitis B.

Entecavir may also be used for other purposes not listed in this medication guide.

Baraclude 0.5 mg

triangular, white, imprinted with BMS, 1611

Baraclude 1 mg

triangular, pink, imprinted with BMS, 1612

What are the possible side effects of entecavir (Baraclude)?

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

Entecavir may cause lactic acidosis (the build up of lactic acid in the body). Lactic acidosis can start slowly and gradually get worse. Contact your doctor at once if you have any of these symptoms, even if they are only mild. Early signs of lactic acidosis generally get worse over time and this condition can be fatal:

• muscle pain or weakness;
• numb or cold feeling in your arms and legs;
• trouble breathing;
• feeling dizzy, light-headed, tired, or very weak;
• stomach pain, nausea with vomiting; or
• slow or uneven heart rate.

Entecavir may also cause severe liver symptoms. Call your doctor at once if you have any of these liver symptoms:

• low fever;
• nausea, stomach pain, loss of appetite;
• dark urine, clay-colored stools; or
• jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• mild nausea, vomiting, diarrhea, upset stomach;
• temporary hair loss;
• headache;
• skin rash; or
• sleep problems (insomnia).

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. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about entecavir (Baraclude)?

You should not take this medication if you are allergic to entecavir, or if you also have HIV (human immunodeficiency virus) that is not being treated.

Some people have developed a life-threatening condition called lactic acidosis while taking entecavir. Get emergency medical help if you have any of these symptoms of lactic acidosis: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

Entecavir 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 entecavir, 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.

What should I discuss with my healthcare provider before taking entecavir (Baraclude)?

You should not take this medication if you are allergic to entecavir, or if you also have HIV (human immunodeficiency virus) that is not being treated.

If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before you take entecavir, tell your doctor if you are allergic to any drugs, or if you have:

• HIV or AIDS;
• kidney disease;
• liver disease; or
• if you have had a liver transplant.

Entecavir may cause lactic acidosis (the build up of lactic acid in the body). Lactic acidosis can start slowly and gradually get worse. Symptoms include muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired. Get emergency medical help if you have any of these symptoms of lactic acidosis, even if they are only mild. Early signs of lactic acidosis generally get worse over time and this condition can be fatal.

You may be more likely to develop lactic acidosis if you have liver disease, kidney disease, or congestive heart failure, or if you drink large amounts of alcohol. Talk with your doctor about your individual risk.

FDA pregnancy category C. It is not known whether entecavir is harmful to an unborn baby. Before you take entecavir, tell your doctor if you are pregnant or plan to become pregnant during treatment.

Your name may need to be listed on an antiviral pregnancy registry when you start using this medication.

It is not known whether entecavir passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take entecavir (Baraclude)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

You may be required to be tested for HIV before you start taking entecavir. Follow your doctor's instructions.

Take entecavir with a full glass of water.

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

Measure the liquid form (oral solution) of entecavir with the dosing spoon provided with this medication. Hold the dosing spoon in an upright position and fill it slowly until the liquid reaches the mark of your correct dose. Rinse the dosing spoon with water after each use. If you do not receive a dosing spoon with your medication, ask your pharmacist for one.

Some people with hepatitis B develop liver symptoms after they stop taking entecavir, 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.

Store entecavir at room temperature away from moisture and heat.

Keep the tablets in a tightly-closed container.

Keep the bottle of oral liquid in its original carton to help protect the medicine from light. Throw away any unused entecavir oral liquid after the expiration date on the label has passed.

What happens if I miss a dose (Baraclude)?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Baraclude)?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of an entecavir overdose are not known.

What should I avoid while taking entecavir (Baraclude)?

Taking entecavir will not prevent you from passing hepatitis B to other people through unprotected sex or sharing of needles. Talk with your doctor about safe methods of preventing hepatitis transmission during sex, such as using a condom and spermicide. Sharing drug or medicine needles is never safe, even for a healthy person.

What other drugs will affect entecavir (Baraclude)?

Before taking entecavir, tell your doctor if you are using any of the following drugs:

• drugs that weaken your immune system (such as cancer medicine or steroids);
• amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet);
• cyclosporine (Neoral, Sandimmune, Gengraf);
• pentamidine (Nebupent, Pentam);
• sirolimus (Rapamune), tacrolimus (Prograf);
• antibiotics such as capreomycin (Capastat), rifampin (Rifadin, Rimactane, Rifater), vancomycin (Vancocin, Vancoled); or
• any other antiviral medicines.

This list is not complete and there may be other drugs that can interact with entecavir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about entecavir.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Last Updated: March 24, 2009