Side Effects

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 this medication has been prescribed because your doctor 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.

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 Adefovir DIPIVOXIL

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.

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.

Rarely, 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.

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.

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. Consult your doctor before breast-feeding.