Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Baraclude

Descriptions


Entecavir belongs to the family of medicines called antivirals. Antivirals are used to treat infections that are caused by viruses. Entecavir is used to treat the liver infection caused by hepatitis B virus. This medicine will not cure the hepatitis B virus, but it will keep it from reproducing and causing more liver damage.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Solution
  • Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of entecavir in children and teenagers younger than 16 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of entecavir in the elderly. However, elderly patients are more likely to have age-related kidney disease, which may require an adjustment in the dose for patients receiving entecavir.

Pregnancy

Information about this entecavir-oral-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Kidney disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.
  • Liver disease—May increase chance for serious side effects.

Proper Use

Take this medicine exactly as directed by your doctor. Do not take it more often, and do not take it for a longer time than your doctor ordered. 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. Also, do not stop taking this medicine without checking with your doctor first.

Take this medicine on an empty stomach (at least two hours after a meal and two hours before the next meal).

Read and follow carefully the patient information leaflet before starting entecavir treatment and each time you refill. Ask your doctor or pharmacist if you have any questions.

Measure the oral solution correctly using the marked measuring spoon that comes with the package. Rinse the dosing spoon with water after each use.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For chronic hepatitis B infection:
    • For oral dosage form (solution or tablets):
      • Adults and teenagers above 16 years of age—0.5 to 1 milligram (mg) or 10 to 20 milliliters (mL) once per day.
      • Children and teenagers below 16 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly. Blood tests may be needed to check for unwanted effects.

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.

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.

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 or your child 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.

Liver disease may become worse if treatment with entecavir is stopped. Do not stop taking entecavir unless your doctor tells you to stop.

Treatment with entecavir has not been shown to decrease the chance of giving hepatitis B virus infection to other people through sexual contact or blood contamination.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

  1. Abdominal or stomach discomfort
  2. decreased appetite
  3. diarrhea
  4. fast, shallow breathing
  5. general feeling of discomfort
  6. muscle pain or cramping
  7. nausea
  8. rash
  9. right upper abdominal or stomach pain and fullness
  10. shortness of breath
  11. sleepiness
  12. unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  1. Headache

Rare

  1. Acid or sour stomach
  2. belching
  3. dizziness
  4. heartburn
  5. indigestion
  6. sleepiness or unusual drowsiness
  7. sleeplessness
  8. stomach discomfort, upset, or pain
  9. trouble sleeping
  10. vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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