What is entecavir?

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.

Precautions

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.

Some people have developed a life-threatening condition called lactic acidosis while taking entecavir. You may be more likely to develop lactic acidosis if you have liver or kidney disease, 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.

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.

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Instructions

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

Symptoms of an entecavir overdose are not known.

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.

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Side Effects

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.

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:

  • 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.

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Interactions

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.

Other Names

Baraclude and entecavir

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Disclaimer

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04

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