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    Hepsera

    GENERIC NAME(S): adefovir

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    WARNINGS:

    Severe worsening of hepatitis (rarely including death) has occurred when treatment with adefovir dipivoxil is stopped. When you are instructed to stop taking this medication, your doctor will monitor you closely for signs of worsening hepatitis. If you are instructed to stop taking this medication, be sure to keep all doctor and lab appointments after you stop taking this drug.

    Infrequently, severe (sometimes fatal) liver and blood acid-base balance problems (lactic acidosis) have occurred in patients (especially if overweight) while using similar types of medication (nucleoside analogs such as didanosine or stavudine). Tell your doctor right away if you have unusual weakness or fatigue, dark urine, yellowing of the skin or eyes, abdominal or stomach pain, drowsiness, muscle aches or weakness, trouble breathing (such as rapid breathing or very shallow breathing), or fast or irregular heartbeat.

    In patients with kidney disease, adefovir dipivoxil can cause kidney problems. Tell your doctor right away if you develop signs of kidney problems such as a change in the amount of urine.

    If you get or have HIV infection that is not being treated with medication, adefovir dipivoxil may cause your HIV infection to become untreatable with the usual HIV drugs (development of HIV resistance). Talk to your doctor or pharmacist for more details.

    Who should not take Hepsera?
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    Uses

    This medication is used to treat a chronic viral infection of the liver (hepatitis B) in people 12 years of age and older. It works by slowing the growth of the virus, helping to lower the amount of virus in your body. It is not a cure for hepatitis B and does not prevent the passing of hepatitis B to others.

    This medication is a nucleotide analog.

    How to use Hepsera

    Read the Patient Information Leaflet if available from your pharmacist before you start taking adefovir and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

    Take this medication by mouth with or without food as directed by your doctor, usually once daily. The dosage is based on your medical condition and response to treatment.

    Use this medication regularly to the get the most benefit from it. To help you remember, take it at the same time each day. Do not increase or decrease your dose or stop taking this medication unless directed to do so by your doctor or pharmacist. Refill your medication before it runs out.

    Treatment with adefovir alone is not appropriate for patients infected with both hepatitis B and HIV. An HIV test is recommended both before and during treatment to ensure you receive appropriate treatment. Consult your doctor or pharmacist for more information.

    Worsening of your condition, decreased response to treatment, or infection by resistant strains of the virus may occur during or after treatment. Tell your doctor right away of any new symptoms that occur during or after treatment.

    Side Effects

    See also Warning section.

    Weakness, headache, fever, increased cough, nausea, vomiting, diarrhea, or gas may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

    Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

    Tell your doctor right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine).

    A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

    This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

    In the US -

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

    In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

    Precautions

    Before taking adefovir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

    Before using this medication, tell your doctor or pharmacist your medical history, especially of: HIV infection, kidney problems, liver transplant.

    During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

    It is unknown if this medication passes into breast milk. Because of possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

    Interactions

    Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

    Some products that may interact with this drug are: cidofovir, nonsteroidal anti-inflammatory drugs (such as ibuprofen).

    Do not take products that contain tenofovir with this medication.

    Overdose

    If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

    Notes

    Do not share this medication with others.

    To avoid spreading hepatitis B to others, practice "safer sex" and always use an effective barrier method (such as latex condoms/dental dams) during sexual activity. Do not share needles. Talk to your doctor or pharmacist for more details.

    Lab and/or medical tests (such as kidney function, liver function tests, and HIV tests) may be done while you are taking this medication. Keep all lab and medical appointments during and for several months after treatment. Consult your doctor for more details.

    Missed Dose

    If you miss a dose, use it as soon as you remember that day. If it is near the time of the next dose, skip themissed dose. Take your next dose at the regular time. Do not double the dose to catch up.

    Storage

    Store in the original container at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

    Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised October 2016. Copyright(c) 2016 First Databank, Inc.

    Images

    Hepsera 10 mg tablet
    Hepsera 10 mg tablet
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    white
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    GILEAD 10, logo
    Hepsera 10 mg tablet
    Hepsera 10 mg tablet

    Identification

    color
    white
    shape
    round
    imprint
    GILEAD 10, logo
    This medicine is a white, round, tablet imprinted with "GILEAD 10" and "logo".

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    Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

    CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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