Adefovir dipivoxil (By mouth)

Introduction

Adefovir Dipivoxil (a-DEF-oh-vir dye-piv-OX-il)

Treats chronic (long-term) hepatitis B infection in patients 12 years of age and older. This is an antiviral medicine.

Brand Name(s)

Hepsera

When This Medicine Should Not Be Used

How to Use This Medicine

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.
• It is important that you do not miss any doses of this medicine. When your supply of this medicine is running low, contact your doctor or pharmacy ahead of time. Do not allow yourself to run out of this medicine.
• Adefovir is used with other medicines to treat HIV infection. Take all other medicines your doctor has prescribed as part of your combination treatment.
• You may take this medicine with or without food.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

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.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• 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.

• Make sure your doctor knows if you are also using other medicines that may be hard on your kidneys, such as cyclosporine (Gengraf®, Neoral®, Sandimmune®), tacrolimus (Prograf®), an antibiotic (such as amikacin, gentamicin, streptomycin, vancomycin, Garamycin®, or Vancocin®), or pain or arthritis medicine (such as diclofenac, etodolac, indomethacin, Daypro®, Dolobid®, Feldene®, Indocin®, Relafen®, or Voltaren®). Do not use this medicine if you are also using tenofovir (Viread®) and other medicines containing tenofovir (such as Atripla? or Truvada®).

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, HIV or AIDS, or other liver disease such as cirrhosis. Tell your doctor if you have had a liver transplant.
• You may need to have a test for HIV/AIDS before you start using this medicine. Adefovir is related to medicines used to treat AIDS. Using adefovir now may cause AIDS medicines to not work. Tell your doctor any time you think you have been exposed to HIV or AIDS.
• Two rare but serious reactions to this medicine are lactic acidosis (build-up of acid in the blood) and an enlarged liver. Call your doctor right away if you feel very tired, weak, or nauseated, if you vomit or have trouble breathing, or if your skin or eyes have turned yellow.
• Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.
• 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.
• This medicine will not keep you from giving hepatitis B to your partner during sex. Make sure you understand and practice safe sex, even if your partner also has hepatitis B. Do not share needles with anyone.

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
• Change in how much or how often you urinate.
• Dark-colored urine or pale stools.
• Extreme weakness, tiredness, or confusion.
• Lightheadedness or fainting.
• Muscle pain or weakness.
• Nausea, vomiting, loss of appetite, or pain in your upper stomach.
• Rapid breathing or troubled breathing.
• Sudden and severe stomach pain and fever.
• Swelling in your hands, ankles, or feet.
• Yellowing of your skin or the whites of your eyes.

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

• Headache.
• Mild stomach upset, gas, or diarrhea.
• Mild weakness.
• Skin rash or itching.

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