Entecavir, Oral

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KEY POINTS

• This medicine is taken by mouth to treat chronic hepatitis B infections. Take it exactly as directed. Do not stop taking this medicine without your healthcare provider's approval. Your symptoms may get worse if you stop taking this medicine too soon.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause life-threatening liver problems, or a buildup of lactic acid in the blood that can be dangerous. It may also cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antiviral

Generic and brand names: entecavir, oral; Baraclude

What is this medicine used for?

This medicine is taken by mouth to treat continuing (chronic) hepatitis B virus infections. It will not cure or prevent hepatitis B infection.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• HIV infection (You may become resistant to another type of this medicine used to treat HIV if you take this medicine)
• Kidney disease
• Liver disease other than hepatitis B

Also, tell your healthcare provider if you have taken any other medicine to treat hepatitis B in the past.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval. Your symptoms may get worse if you stop taking this medicine too soon. Do not run out of this medicine.

Check with your healthcare provider before using this medicine in children under age 2.

Take this medicine on an empty stomach, at least 2 hours before or 2 hours after a meal. Take it at the same time each day to help you remember to take it.

If you are taking the liquid, use the measuring spoon, cup, dropper, or oral syringe that comes with the medicine, or ask your pharmacist for one. Do not use a kitchen spoon because the dose may not be correct. Swallow the medicine directly from the measuring spoon. Do not mix it with any other liquid before taking. After each use, rinse the spoon with water and allow it to air dry.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose or you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose have not been reported.

What should I watch out for?

You should be tested for HIV infection before taking this medicine and while taking this medicine. If you have an HIV infection and take this medicine, the HIV infection can become more difficult to treat.

This medicine can cause serious or life-threatening liver problems. You will need to have blood tests regularly while taking this medicine and for several months after you stop taking this medicine. Keep all appointments for these tests.

Lactic acidosis is a rare but serious complication that can happen with use of this medicine. This condition is caused by a buildup of lactic acid in the blood. The symptoms of lactic acidosis are:

• Feeling very weak or tired
• Unusual muscle pain
• Having trouble breathing
• Feeling cold, especially in your arms and legs
• Being dizzy and lightheaded
• Stomach pain with nausea and vomiting
• Suddenly developing a fast or irregular heartbeat

This medicine does not cure hepatitis B or keep you from spreading it to other people. Practice safe sex and do not share needles, toothbrushes, or razor blades with others.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. Carry an ID card or a Medic Alert bracelet. If you become unconscious, the ID tells emergency healthcare providers that you may need special care.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Muscle pain, trouble breathing, severe stomach pain, severe nausea or vomiting, fast or irregular heartbeat, dark urine, decreased urination, light-colored bowel movements, yellowing of your skin or eyes, loss of appetite, unusual tiredness or weakness, feeling cold (especially in your arms and legs), unexplained swelling in your hands or feet, severe dizziness.

Other: Nausea, vomiting, tiredness, headache, tiredness, dizziness, trouble sleeping, diarrhea, heartburn, rash, hair loss.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Amphotericin b (Abelcet, AmBisome, Amphotec)
• Antiarrhythmic medicines (to treat irregular heartbeat) such as digoxin (Lanoxin), dofetilide (Tikosyn), procainamide, and quinidine
• Antibiotics such as amikacin, gentamicin, kanamycin, tobramycin, and vancomycin (Vancocin)
• Antiviral medicines such as acyclovir (Zovirax), ganciclovir (Cytovene), ribavirin (Copegus, Rebetol, Ribasphere, Virazole), valacyclovir (Valtrex), and valganciclovir (Valcyte)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet) and ranitidine (Zantac)
• Memantine (Namenda)
• Metformin (Fortamet, Glucophage, Riomet)
• Midodrine
• Morphine (Kadian, MS Contin)
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen (Oruvail), ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Quinine
• Triamterene/hydrochlorothiazide (Dyazide, Maxzide) and triamterene (Dyrenium)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.