September 3, 2015
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Epivir

"The combinations of anti-HIV drugs recommended for pregnant women do not appear in general to increase their children's risk for language delay, according to a study from a National Institutes of Health research network.

Children ex"...

Epivir




PATIENT INFORMATION

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.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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