Epivir HBV

Epivir HBV is a prescription medication used to treat treat chronic hepatitis B virus infection. Epivir HBV belongs to a group of drugs called nucleoside reverse transcriptase inhibitors (NRTI), which block a process hepatitis B viruses need to reproduce.

This medication comes in tablet and oral liquid forms and is taken once a day, with or without food.

Some of the common side effects of Epivir HBV include ear, nose, throat infections, sore throat, and diarrhea. 

Epivir HBV is the prescription medication used to treat chronic hepatitis B virus infection in adults and children.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. 

• Glaxo SmithKline Pharmaceuticals

Serious side effects can occur with Epivir HBV use. See "Epivir HBV Precautions" section.

Commonly reported side effects include:

• headache
• ear, nose or throat infections
• sore throat
• malaise (general ill feeling) and fatigue
• nausea
• diarrhea
• cough
• fever
• chills
• muscle and joint pain

This is not a complete list of Epivir HBV side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• interferon medications
• emtricitabine
• zalcitabine (Hivid)
• trimethoprim/sulfamethoxazole (Bactrim, Septra), an antibiotic

Ask your doctor if you are unsure if you are taking any of these medications.

This is not a complete list of Epivir HBV drug interactions. Ask your doctor or pharmacist for more information.

Some severe side effects have been reported with Epivir HBV use including the following:

Lactic Acidosis/Severe Hepatomegaly With Steatosis. Epivir HBV can cause serious damage to the liver and a condition called lactic acidosis. If you experience any of the following symptoms, call your doctor immediately: 

Pancreatitis. Epivir HBV can cause life-threatening inflammation of the pancreas (pancreatitis). Tell your doctor immediately if you have any signs of pancreatitis, such as:

• fast heart rate 
• short, quick breaths
• nausea and vomiting
• fever
• swollen, tender abdomen (stomach area)

Fat Redistribution. Epivir HBV can change the distribution of fat on your body. You may gain fat in areas such as in the abdomen or at the back of the neck (a "buffalo hump"), and may lose weight in other areas.

Worsening of hepatitis (inflammation of the liver) when treatment with Epivir HBV is stopped. Your doctor will monitor you and your labs for at least several months after you stop taking Epivir HBV. 

Do not take Epivir HBV if you:

• are allergic to Epivir HBV or to any of its ingredients
• are taking other medications containing lamivudine
• are taking emtricitabine

There is a risk of HIV-1 Resistance if this medication is used in patients with unrecognized or untreated HIV-1 infection. Epivir HBV tablets and oral solution contain a lower dose of the active ingredient, lamivudine. If there is a co-infection (HIV and HBV), then the higher dose should be prescribed and taken. 

Epivir HBV does not stop you from spreading HBV to others by sex, sharing needles, or being exposed to your blood. Avoid doing things that can spread HBV infection to others.

• Do not share or re-use needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
• Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood. 

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Epivir HBV there are no specific foods that you must exclude from your diet when receiving Epivir HBV.

Before receiving Epivir HBV, tell your doctor if you:

• are allergic to Epivir HBV or any of the other ingredients in Epivir HBV
• have HIV-1 infection
• have ever had liver disease such as liver failure, cirrhosis, or hepatitis
• are seriously overweight (especially if you’re a woman)
• are diabetic (Epivir HBV contains sucrose)
• use insulin
• have kidney disease
• have had pancreatitis (inflammation of the pancreas) in the past, particularly children

Tell your doctor if you are pregnant or breastfeeding.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. It is not known if Epivir HBV will harm your unborn baby. There are no adequate and well-controlled trials of Epivir HBV in pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed. Epivir HBV has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Epivir HBV, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Epivir HBV comes as a tablet and liquid to take by mouth, usually once daily. Epivir HBV can be taken with or without food.

Take Epivir HBV exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take Epivir HBV even if you feel well. Do not stop taking Epivir HBV without talking to your doctor.

If you miss a dose, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your kidney function
• your weight
• your height
• your age
• your gender

Adults, for the treatment of chronic hepatitis B

• The recommended oral dose of Epivir HBV (lamivudine) for treatment of chronic hepatitis B in adults is 100 mg once daily.
• The dose may be reduced if you have kidney problems. 

If you take too much Epivir HBV, call your local Poison Control Center or seek emergency medical attention right away.

• Store Epivir HBV tablets at room temperature between 15° to 30°C (59° to 86°F).
• Epivir HBV oral solution does not require refrigeration, but should be stored tightly closed in a cool place.
• Keep this and all medicines out of the reach of children.

WARNING: RISK OF LACTIC ACIDOSIS, EXACERBATIONS OF HEPATITIS B IN CO-INFECTED PATIENTS UPON DISCONTINUATION OF EPIVIR HBV, DIFFERENT FORMULATIONS OF LAMIVUDINE:

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including Epivir HBV and other antiretrovirals. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur.

Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued Epivir HBV. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue Epivir HBV and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Epivir, which is used to treat HIV-1 infection, contains a higher dose of the active ingredient (lamivudine) than Epivir HBV which is used to treat chronic HBV infection. Patients with HIV-1 infection should receive only dosage forms appropriate for treatment of HIV-1.