Lamivudine/Tenofovir DF

Documented hypersensitivity (eg, Stevens-Johnson syndrome, erythema multiforme, toxic skin eruptions) to any components contained in the formulation

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with use of nucleoside analogs and other ARTs; suspend treatment in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity

Clinical trials in HIV-infected subjects demonstrated regimens contained only 3 NRTIs are generally less effective than triple drug regimens containing 2 NRTIs in combination with either a non-nucleoside reverse transcriptase inhibitor or a HIV-1 protease inhibitor; early virological failure and high rates of resistance substitutions reported; use triple NRTI regimens with caution; carefully monitor patients on a therapy utilizing a triple nucleoside-only regimen and consider for treatment modification

Not approved for chronic hepatitis B virus (HBV) infection and safety and efficacy not established in patients coinfected with HBV and HIV-1; if treatment with Epivir-HBV, tenofovir DF, or a tenofovir AF-containing product is prescribed for chronic hepatitis B for a patient with unrecognized or untreated HIV-1 infection, rapid emergence of HIV-1 resistance is likely to result because of subtherapeutic dose and the inappropriateness of monotherapy HIV-1 treatment (see Black Box Warnings and Dosing Considerations)

Immune reconstitution syndrome reported in HIV-infected patients treated with combination ART; during initial phase of combination ART, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (eg, Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia (PCP), tuberculosis), and further evaluation and treatment may be necessary

Autoimmune disorders (eg, Grave disease, polymyositis, and Guillain-Barré syndrome) reported to occur in the immune reconstitution setting; however, time to onset varies and can occur many months after initiation of treatment

In HIV-infected patients, redistribution/accumulation of body fat (eg, central obesity, dorsocervical fat enlargement [buffalo hump], peripheral wasting, facial wasting, breast enlargement, and cushingoid appearance) observed in patients receiving combination ART

In pediatric patients with a history of prior antiretroviral nucleoside exposure, a history of pancreatitis, or other significant risk factors for the development of pancreatitis, lamivudine should be used with caution