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Hepsera

Generic Name: adefovir (a-DEF-oh-vir)
Brand Name: Hepsera

Some patients have developed severe and sometimes fatal worsening of hepatitis after they stop taking Hepsera. If you stop taking Hepsera, your doctor will need to perform liver function tests and check you closely for signs of worsening liver problems for at least several months. Be sure to keep all doctor and lab appointments.

Hepsera may cause serious kidney problems, especially if you already have or are at risk for kidney problems. Tell your doctor if you have a history of kidney problems. They may need to perform kidney function tests or adjust your dose of Hepsera. Contact your doctor right away if you develop a change in the amount of urine that you produce.

Use of Hepsera for hepatitis B infection in patients with untreated or unknown HIV infection may result in strains of the HIV virus that are resistant to treatment. Tell your doctor if you have HIV infection or may be at risk for HIV infection.

High levels of lactic acid in the blood and severe liver problems have infrequently been reported with the use of Hepsera either alone or with other medicines. These effects have been fatal in some cases. The risk of developing these problems may be greater if you are a woman, are very overweight, or have liver problems. It may also be increased in patients who have taken certain HIV medicines for a prolonged period of time. Notify your doctor immediately if you develop symptoms of new or worsening liver problems (eg, dark urine, yellowing of the skin or eyes, pale stools, loss of appetite, stomach pain) or symptoms of lactic acidosis (eg, severe or unusual drowsiness, tiredness, or weakness; dizziness; light-headedness; coldness, especially in the arms or legs; fast breathing; shortness of breath; sluggishness; unusual muscle pain or cramps; unusual nausea or vomiting; fast or irregular heartbeat).


Hepsera is used for:

Treating chronic hepatitis B virus (HBV) infection.

Hepsera is a nucleotide analog. It works by slowing the growth of the virus. It is not a cure for hepatitis B.

Do NOT use Hepsera if:

  • you are allergic to any ingredient in Hepsera
  • you have an enlarged liver or high levels of lactic acid in the blood (lactic acidosis)
  • you are taking tenofovir or another medicine that contains tenofovir

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Hepsera:

Some medical conditions may interact with Hepsera. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of kidney problems, liver problems, abnormal liver function, a liver transplant, or lactic acidosis
  • if you have high blood pressure or diabetes
  • if you have HIV infection, are at risk for HIV infection, or are very overweight
  • if you have taken lamivudine to treat HBV infection and it stopped working well (lamivudine-resistant HBV)

Some MEDICINES MAY INTERACT with Hepsera. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Nucleoside analogs (eg, didanosine, lamivudine) because the risk of lactic acidosis or severe liver problems may be increased
  • Medicines that may harm your kidneys (eg, aminoglycosides [eg, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, tenofovir, vancomycin) because the risk of severe kidney problems may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hepsera may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Hepsera:

Use Hepsera as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Hepsera. Talk to your pharmacist if you have questions about this information.
  • Take Hepsera by mouth with or without food.
  • Take Hepsera on a regular schedule to get the most benefit from it.
  • Continue to use Hepsera even if you feel well. Do not miss any doses.
  • If you miss a dose of Hepsera, take it as soon as possible if you remember that same day. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take more than 1 dose in a day. Do not take 2 doses at once. If you are not sure what to do if you miss a dose of Hepsera, contact your health care provider.

Ask your health care provider any questions you may have about how to use Hepsera.

Important safety information:

  • Hepsera will not cure chronic hepatitis B. It may help reduce the amount of HBV in your body. Remain under the care of your doctor.
  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Hepsera, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
  • Do NOT stop taking Hepsera or change your dose without checking with your doctor. The risk of severe liver problems may be greater if you suddenly stop Hepsera.
  • Hepsera does not stop the spread of HBV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HBV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.
  • You should be tested for HIV before taking Hepsera and anytime there is a chance that you are exposed to HIV. If you have or contract HIV that is not being treated, Hepsera may stop usual HIV medicines from controlling your HIV infection.
  • Worsening of your condition, decreased response to Hepsera, or development of resistant strains of the virus may occur during or after treatment. Tell your doctor immediately if any new symptoms occur during or after treatment.
  • Lab tests, including liver and kidney function, may be performed when you use Hepsera. These tests may be used to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Hepsera with caution in the ELDERLY; they may be more sensitive to its effects.
  • Hepsera should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hepsera while you are pregnant. It is not known if Hepsera is found in breast milk. Do not breast-feed while taking Hepsera.

Possible side effects of Hepsera:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; gas; headache; indigestion; mild stomach pain; nausea; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bone pain; change in the amount of urine you produce; dizziness or light-headedness; fast breathing; fast or irregular heartbeat; feeling of being unusually cold (especially in the arms or legs); severe or persistent nausea or vomiting; severe or unusual drowsiness; severe stomach or back pain (with or without nausea or vomiting); shortness of breath; sluggishness; symptoms of new or worsening liver problems (eg, dark urine, loss of appetite, pale stools, severe stomach pain, yellowing of the skin or eyes); unusual muscle pain or cramps; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Hepsera:

Store Hepsera at 77 degrees F (25 degrees C) in the original container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not use if the seal over the bottle opening is broken or missing. Do not store in the bathroom. Keep Hepsera out of the reach of children and away from pets.

General information:

  • If you have any questions about Hepsera, please talk with your doctor, pharmacist, or other health care provider.
  • Hepsera is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Hepsera or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Hepsera. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Hepsera. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Hepsera.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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