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 Entecavir
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F.C. Binder
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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 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. 

Some people have developed a  life-threatening condition called lactic acidosis while taking enteavir. Early signs  of lactic acidosis generally get worse over time and this condition can be fatal. 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, 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? 

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.

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  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? 

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. 

Entecavir 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 

Entecavir Dosing Information 

Usual Adult Dose for Chronic Hepatitis B: 

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 

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 

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. 

 

Notes:
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EditText of this page (last edited April 13, 2010)

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