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.
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:
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 of entecavir?
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.
Where can I get more information about entecavir?
Your pharmacist has information about entecavir written for health professionals that you may read.
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.
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.
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 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 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.
What happens if I have an overdose of entecavir?