What is this medication?

ENTECAVIR (en TE ka veer) is an antiviral medicine. It is used to treat chronic hepatitis B. This medicine will not cure or prevent hepatitis B infection.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Baraclude

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• immune system problems
• kidney disease
• other liver disease
• an unusual or allergic reaction to entecavir, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine on an empty stomach, at least 2 hours before or 2 hours after food. Do not take with food. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years old for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• capreomycin
• colistimethate, colistin, polymyxin E
• dofetilide
• procainamide
• quinidine
• quinine
• vancomycin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your doctor or health care professional for regular check ups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine.

Your hepatitis infection may get worse after you stop taking this medicine. Do not stop taking this medicine unless your doctor tells you to.

Hepatitis B is spread to others through sexual or blood contact. Talk to your doctor about how to stop the spread of Hepatitis B.

Tell your doctor if you also have HIV. You need to be on medicines to treat your HIV infection while you are taking this medicine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing difficulties
• dark urine
• general ill feeling or flu-like symptoms
• light-colored stools
• loss of appetite
• nausea, vomiting, unusual stomach upset or pain
• right upper belly pain
• unusually weak or tired
• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• dizzy
• headache
• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.