Epivir (Lamivudine) Drug Information: Medication Guide and Patient Information

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May 27, 2012

Epivir

Hepatitis B »

What is hepatitis?

The term 'hepatitis' simply means inflammation of the liver. Hepatitis may be caused by a virus or a toxin such as alcohol. Other viruses that can cause injury to liver cells include the hepatitis A and hepatitis C viruses. These viruses are not related to each other or to hepatitis B virus and differ in their structure, the ways they are spread among individuals, the severity of symptoms they can cause, the way they are treated, and the outcome of the infection.

What is the scope of the problem?

Hepatitis B is an infection of the liver caused by the hepatitis B virus (HBV). It is estimated that 350 million individuals worldwide are infected with the virus, which causes 620,000 deaths worldwide each year. According to the Centers for Disease Control (CDC), approximately 46,000 new cases of hepatitis B occurred in the United States in 2006.

In the United States, rates of new infection were highest ...

Read the Hepatitis B article »

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PATIENT INFORMATION

Advice for the Patient

Information About Therapy With EPIVIR (lamivudine) : EPIVIR (lamivudine) is not a cure for HIV-1 infection and patients may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. Patients should remain under the care of a physician when using EPIVIR (lamivudine) . Patients should be advised that the use of EPIVIR (lamivudine) has not been shown to reduce the risk of transmission of HIV-1 to others through sexual contact or blood contamination.

Patients should be advised that the long-term effects of EPIVIR (lamivudine) are unknown at this time.

Patients should be advised of the importance of taking EPIVIR (lamivudine) with combination therapy on a regular dosing schedule and to avoid missing doses.

EPIVIR (lamivudine) should not be coadministered with drugs containing lamivudine or emtricitabine, including COMBIVIR (lamivudine/zidovudine) Tablets, EPZICOM (abacavir sulfate and lamivudine) Tablets, TRIZIVIR (abacavir sulfate, lamivudine, and zidovudine), ATRIPLA (efavirenz, emtricitabine, and tenofovir), EMTRIVA (emtricitabine) or TRUVADA (emtricitabine and tenofovir) [see WARNINGS and PRECAUTIONS].

Redistribution/Accumulation of Body Fat: Patients should be informed that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy, including EPIVIR (lamivudine) , and that the cause and long-term health effects of these conditions are not known at this time [see WARNINGS and PRECAUTIONS].

Differences in Formulations of EPIVIR (lamivudine) : Patients should be advised that EPIVIR (lamivudine) Tablets and Oral Solution contain a higher dose of the same active ingredient (lamivudine) as EPIVIR (lamivudine) -HBV Tablets and Oral Solution. If a decision is made to include lamivudine in the HIV-1 treatment regimen of a patient co-infected with HIV-1 and HBV, the formulation and dosage of lamivudine in EPIVIR (lamivudine) (not EPIVIR (lamivudine) -HBV) should be used [see Warnings and PRECAUTIONS].

Co-infection With HIV-1 and HBV: Patients co-infected with HIV-1 and HBV should be informed that deterioration of liver disease has occurred in some cases when treatment with lamivudine was discontinued. Patients should be advised to discuss any changes in regimen with their physician [see WARNINGS and PRECAUTIONS].

Risk of Pancreatitis: Parents or guardians should be advised to monitor pediatric patients for signs and symptoms of pancreatitis [see WARNINGS and PRECAUTIONS].

Sucrose Content of EPIVIR (lamivudine) Oral Solution: Diabetic patients should be advised that each 15-mL dose of EPIVIR (lamivudine) Oral Solution contains 3 grams of sucrose [see DESCRIPTION].

Last reviewed on RxList: 3/11/2011
This monograph has been modified to include the generic and brand name in many instances.