Abacavir/Lamivudine

Patients who have the HLA-B*5701 allele

Prior hypersensitivity to abacavir or lamivudine

Moderate or severe hepatic impairment

Review medical history for hypersensitivity to abacavir before administration; discontinue at first signs of hypersensitivity

Patients with creatinine clearance between 30-49 mL/min receiving drug combination may experience a 1.6-3.3-fold higher lamivudine exposure (AUC) than patients with a creatinine clearance ≥50 mL/min; monitor for hematologic toxicities

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with nucleoside analogues, including abacavir and lamivudine (components of the combination product); a majority of these cases have been in women; female gender and obesity may be risk factors; suspend dosing in those who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity

Exacerbation of hepatitis B may occur on discontinuation

Immune reconstitution syndrome reported with combination ART; during the initial treatment phase, 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], or tuberculosis); autoimmune disorders (eg, Grave disease, polymyositis, and Guillain-Barré syndrome) have also been reported

Use has been associated with increased risk of myocardial infarction in observational studies, but not in a meta-analysis of 26 randomized trials; caution with risks for coronary heart disease and minimizing modifiable risk factors, including smoking, hypertension, and hyperlipidemia, prior to use

Concomitant administration of emtricitabine with lamivudine-containing products not recommended

Hepatic decompensation, some fatal, reported in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy and interferon alfa with or without ribavirin; discontinue therapy as medically appropriate and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both