Entecavir (By mouth)

Introduction

Entecavir (en-TEK-a-vir)

Treats chronic hepatitis B infection.

Brand Name(s)

Baraclude

When This Medicine Should Not Be Used

How to Use This Medicine

Liquid, Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• Take this medicine on an empty stomach, at least 2 hours before or 2 hours after a meal.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
• Measure the oral liquid medicine correctly using the marked measuring spoon that comes with the package. Rinse the dosing spoon with water after each use.
• When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.
• Do not stop using this medicine without asking your doctor. Do not change your dose or schedule for taking this medicine unless your doctor tells you to.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Do not throw any unused medicine in the trash. Flush it down the toilet or take it to a community take-back program when available. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine

• It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients taking this medicine.
• Make sure your doctor knows if you are breastfeeding, or if you have kidney disease or liver disease.
• Two rare, but serious, reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you feel tired, weak, dizzy, or nauseated, if you vomit or have stomach pain, dark urine, light-colored stools, unusual muscle pains, or trouble with breathing, or if your skin or eyes turn yellow.
• Your doctor may want to check your liver for several months after you stop using this medicine.
• This medicine will not keep you from spreading hepatitis B to another person through sexual contact or contact with your blood.
• If you have or get HIV (human immunodeficiency virus) infection, be sure to discuss your treatment with your doctor. If you are taking this medicine to treat chronic hepatitis B and are not taking medicines for your HIV at the same time, some HIV treatments that you take in the future may be less likely to work. Your doctor may need you to get an HIV test before you start taking this medicine and anytime after that when there is a chance you were exposed to HIV. This medicine will not help your HIV infection.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark-colored urine or pale stools.
• Extreme weakness, tiredness, or confusion.
• Fast or uneven heartbeat.
• Lightheadedness or fainting.
• Nausea, vomiting, loss of appetite, or pain in your upper stomach.
• Rapid breathing or trouble with breathing.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Headache.
• Mild nausea, diarrhea, or upset stomach.
• Trouble sleeping.

If you notice other side effects that you think are caused by this medicine, tell your doctor

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