October 10, 2015
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Lactic Acidosis/Hepatomegaly

Inform patients that some HIV medicines, including EPIVIR, can cause a rare, but serious condition called lactic acidosis with liver enlargement (hepatomegaly) [see WARNINGS AND PRECAUTIONS].

HIV-1/HBV Co-infection

Inform patients co-infected with HIV-1 and HBV that deterioration of liver disease has occurred in some cases when treatment with lamivudine was discontinued. Advise patients to discuss any changes in regimen with their physician [see WARNINGS AND PRECAUTIONS].

Differences in Formulations of EPIVIR

Advise patients that EPIVIR tablets and oral solution contain a higher dose of the same active ingredient (lamivudine) as EPIVIR-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 (not EPIVIR-HBV) should be used [see WARNINGS AND PRECAUTIONS].

Use with Other Lamivudine- and Emtricitabine-containing Products

EPIVIR 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), STRIBILD (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate), TRUVADA (emtricitabine and tenofovir), or COMPLERA (rilpivirine/emtricitabine/tenofovir) [see WARNINGS AND PRECAUTIONS].

HIV-1/HCV Co-infection

Inform patients with HIV-1/HCV co-infection that hepatic decompensation (some fatal) has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin [see WARNINGS AND PRECAUTIONS].

Risk of Pancreatitis

Advise parents or guardians to monitor pediatric patients for signs and symptoms of pancreatitis [see WARNINGS AND PRECAUTIONS].

Redistribution/Accumulation of Body Fat

Inform patients that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy, including EPIVIR, and that the cause and long-term health effects of these conditions are not known at this time [see WARNINGS AND PRECAUTIONS].

Sucrose Content of EPIVIR Oral Solution

Advise diabetic patients that each 15-mL dose of EPIVIR oral solution contains 3 grams of sucrose (1 mL = 200 mg of sucrose) [see DESCRIPTION].

Information about HIV-1 Infection

EPIVIR is not a cure for HIV-1 infection and patients may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. Patients must remain on continuous HIV therapy to control HIV-1 infection and decrease HIV-related illness. Patients should be told that sustained decreases in plasma HIV-1 RNA have been associated with a reduced risk of progression to AIDS and death. Patients should remain under the care of a physician when using EPIVIR.

Patients should be informed to take all HIV medications exactly as prescribed.

Patients should be advised to avoid doing things that can spread HIV-1 infection to others.

  • Do not re-use or share needles or other injection equipment.
  • Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
  • Continue to practice safer sex by using a latex or polyurethane condom or other barrier method to lower the chance of sexual contact with semen, vaginal secretions, or blood.
  • Female patients should be advised not to breastfeed. Mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.

Last reviewed on RxList: 3/6/2015
This monograph has been modified to include the generic and brand name in many instances.

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