Entecavir

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

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.

This medication may cause lactic acidosis (the build up of lactic acid in the body). Lactic acidosis can start slowly and gradually get worse. Symptoms include unusual muscle pain and weakness, trouble breathing, fast or uneven heart rate, nausea, vomiting, stomach pain, and numbness or cold feeling in your arms or legs. 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.

Entacavir 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 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.

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

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.

Before taking entecavir, tell your doctor if you are allergic to any drugs, or if you have:

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

If you have any of these conditions, you may need a dose adjustment or special tests to safely take entecavir.

FDA pregnancy category C. This medication may be harmful to an unborn baby. 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?

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 a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, 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.

What happens if I miss a dose?

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?

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?

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 are the possible side effects of entecavir?

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;
• nausea with vomiting; or
• fast 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;
• headache;
• skin rash; or
• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect entecavir?

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.

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 1996-2003 Cerner Multum, Inc. Version: 2.05. Revision date: 09/27/2007.