ENTECAVIR- entecavir tablet, film coated 
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Patient Information

Entecavir Tablets, USP

(en-TEK-a-vir)

Read this Patient Information before you start taking entecavir tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

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

1. Your hepatitis B virus (HBV) infection may get worse if you stop taking entecavir tablets.

This usually happens within 6 months after stopping entecavir tablets.

2. If you have or get HIV that is not being treated with medicines while taking entecavir tablets, the HIV virus may develop resistance to certain HIV medicines and become harder to treat. You should get an HIV test before you start taking entecavir tablets and anytime after that when there is a chance you were exposed to HIV.

Entecavir tablets can cause serious side effects including:

3. Lactic acidosis (buildup of acid in the blood). Some people who have taken entecavir tablets or medicines like entecavir tablets (a nucleoside analogue) have developed a serious condition called lactic acidosis. Lactic acidosis is a serious medical emergency that can cause death. Lactic acidosis must be treated in the hospital. Reports of lactic acidosis with entecavir tablets generally involved patients who were seriously ill due to their liver disease or other medical condition.

Call your healthcare provider right away if you get any of the following signs or symptoms of lactic acidosis:

4. Serious liver problems. Some people who have taken medicines like entecavir tablets have developed serious liver problems called hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Hepatomegaly with steatosis is a serious medical emergency that can cause death.

Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems:

You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight, or have been taking nucleoside analogue medicines, like entecavir tablets, for a long time.

What is entecavir?

Entecavir is a prescription medicine used to treat chronic hepatitis B virus (HBV) in adults and children 2 years of age and older who have active liver disease.

What should I tell my healthcare provider before taking entecavir tablets?

Before you take entecavir tablets, tell your healthcare provider if you:

Antiretroviral Pregnancy Registry. If you take entecavir tablets while you are pregnant, talk to your healthcare provider about how you can take part in the entecavir tablets Antiretroviral Pregnancy Registry. The purpose of the pregnancy registry is to collect information about the health of you and your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you have taken a medicine to treat HBV in the past.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine.

How should I take entecavir tablets?

What are the possible side effects of entecavir tablets?

Entecavir tablets may cause serious side effects. See “ What is the most important information I should know about entecavir tablets?

The most common side effects of entecavir tablets include:

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of entecavir tablets. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store entecavir tablets?

Keep entecavir tablets and all medicines out of the reach of children.

General information about the safe and effective use of entecavir tablets

Entecavir tablets do not stop you from spreading the hepatitis B virus (HBV) to others by sex, sharing needles, or being exposed to your blood. Talk with your healthcare provider about safe sexual practices that protect your partner. Never share needles. Do not share personal items that can have blood or body fluids on them, like toothbrushes or razor blades. A shot (vaccine) is available to protect people at risk from becoming infected with HBV.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use entecavir tablets for a condition for which it was not prescribed. Do not give entecavir tablets to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about entecavir tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about entecavir tablets that is written for health professionals.

For more information, call AvKARE at 1-855-361-3993.

What are the ingredients in entecavir tablets?

Active ingredient: entecavir

Inactive ingredients in entecavir tablets: lactose monohydrate, microcrystalline cellulose, crospovidone, povidone, magnesium stearate.

Tablet film-coat: titanium dioxide, talc, polyethylene glycol 3350, lecithin (soya), polyvinyl alcohol-part hydrolyzed, and iron oxide red (1 mg tablet only).

Manufactured for:

AvKARE

Pulaski, TN 38478

Mfg. Rev. 06/20

AV 09/20 (P)

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Revised: 1/2022
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