Lactic acidosis and severe hepatomegaly with steatosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with use of nucleoside analogs alone or in combination, including abacavir, lamivudine and other antiretrovirals. A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors. Exercise particular caution when administering Alacovir tablet to any patient with known risk factors for liver disease; however, cases have also been reported in patients with no known risk factors. Suspend treatment with Alacovir tablet in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatoxicity (which may include hepatomegaly and steatosis, even in the absence of marked transaminase elevations).
Immune Reconstitution Syndrome: Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including abacavir/lamivudine. During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jiroveci pneumonia (PJP), or tuberculosis), which may necessitate further evaluation and treatment.
Fat redistribution: Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving antiretroviral therapy.
Emergence of lamivudine-resistant HBV: Safety and efficacy of lamivudine have not been established for treatment of chronic hepatitis B in patient dually infected with HIV-1 and HBV. In non-HIV-1-infected patients treated with lamivudine for chronic hepatits B; emergence of lamivudine-resistant HBV has been detected and has been associated with diminished treatment response. Emergence of hepatitis B virus variants associated with resistance to lamivudine has also been reported in HIV-1-infected patients who have received lamivudine-containing antiretroviral regimens in the presence of concurrent infection with hepatitis B virus.
Myocardial infarction: Consider the underlying risk of coronary heart disease when prescribing antiretroviral therapies, including abacavir, and take action to minimize all modifiable risk factors (eg, hypertension, hyperlipidemia, diabetes mellitus, smoking).
Renal function impairment: Because Alacovir is a fixed-dose tablet and the dosage of the individual components cannot be altered, patients with CrCl less than 50 mL/min should not receive Alacovir tablet.
Hepatic function impairment: Abacavir/lamivudine is contraindicated in patients with hepatic impairment because it is a fixed-dose tablet and the dosage of the individual components cannot be adjusted.
Effect on ability to drive and use machine: Data is not available.
Use in Children: Safety and effectiveness of abacavir/lamivudine in pediatric patients have not been established. Abacavir/lamivudine is not recommended for use in patients younger than 18 years because it cannot be dose adjusted.