IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

ADEFOVIR DIPIVOXIL - ORAL

(ah-DEH-foe-veer dip-ih-VOX-il)

COMMON BRAND NAME(S): Hepsera

WARNING: Severe worsening of hepatitis (rarely including death) has occurred when adefovir dipivoxil has been discontinued. When you are instructed to stop taking this medication, your doctor will monitor you closely for signs of worsening hepatitis. Be sure to keep all doctor and laboratory appointments after you stop taking this drug. Infrequently, severe (sometimes fatal) liver and blood acid-base balance problems (lactic acidosis) have occurred infrequently while using a similar type of medication (nucleoside analogs such as didanosine or stavudine). Notify your doctor immediately if you develop unusual weakness or fatigue, dark urine, yellowing of the skin or eyes, abdominal or stomach pain, drowsiness, muscle aches or weakness, trouble breathing (e.g., rapid breathing or very shallow breathing), or fast or irregular heartbeat. In patients with kidney disease, adefovir dipivoxil can cause kidney damage. Notify your doctor immediately if you develop a change in the amount of urine that you produce. 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). Consult your doctor or pharmacist for more details.

USES: This medication is an acyclic nucleotide analog used to treat a chronic viral infection of the liver (hepatitis B). It works by slowing the growth of the virus. It is not a cure for hepatitis B and does not prevent the passing of hepatitis B to others.

HOW TO USE: Take this medication by mouth, usually once daily; or take as directed by your doctor. May take with or without food. This medicine comes with a patient information leaflet. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. Take this medication exactly as prescribed. Do not increase or decrease your dose or stop taking this medication unless directed to do so by your doctor or pharmacist. 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 therapy, or the occurrence of resistant strains of the virus may occur during or after treatment. Promptly report any new symptoms that occur during or after treatment to your doctor.

SIDE EFFECTS: Weakness, headache, fever, increased cough, nausea, vomiting, diarrhea, or gas may occur. If any of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if this very unlikely but serious side effect occurs: change in the amount of urine. For additional side effects see Warning section. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist your medical history, especially of: HIV infection, kidney problems, liver transplant, allergies. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Do not breast-feed while taking this medication.

DRUG INTERACTIONS: Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: aminoglycosides (e.g., gentamicin, amikacin), amphotericin B, cyclosporine, non-steroidal anti-inflammatory drugs (e.g., ibuprofen), tacrolimus, vancomycin. Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., kidney function and liver function tests) may be performed to monitor your progress or check for side effects. Consult your doctor for more details. Keep all laboratory and medical appointments during and for several months after treatment. If using this medication for an extended period of time, obtain refills before your supply runs out.

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 the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store in the original container at room temperature (77 degrees F or 25 degree C) away from light and moisture. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep away from children and pets.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).

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Copyright 2004 by First DataBank, Inc.