Abacavir, Lamivudine and Zidovudine

Abacavir, lamivudine and zidovudine tablet, a combination of abacavir, lamivudine, and zidovudine, each nucleoside analogue HIV-1 reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Abacavir, lamivudine and zidovudine tablet is indicated in combination with other antiretrovirals or alone for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Limitations of Use: Limited data exist on the use of abacavir, lamivudine and zidovudine tablets alone in patients with higher baseline viral load levels (greater than 100,000 copies per mL).

Abacavir, lamivudine and zidovudine tablet is an antiretroviral agent.

Before initiating abacavir, lamivudine and zidovudine tablets, screen for the HLA-B*5701 allele because abacavir, lamivudine and zidovudine tablet contains abacavir. Adults and pediatric patients weighing at least 40 kg: 1 tablet twice daily. Because abacavir, lamivudine and zidovudine tablet is a fixed-dose tablet and cannot be dose adjusted, abacavir, lamivudine and zidovudine tablets are not recommended in patients requiring dosage adjustment or patients with hepatic impairment.

Presence of HLA-B*5701 allele. Prior hypersensitivity reaction to abacavir, lamivudine, or zidovudine. Moderate or severe hepatic impairment. Abacavir, lamivudine and zidovudine tablets are contraindicated in patients: who have the HLA-B*5701 allele. with prior hypersensitivity reaction to abacavir, lamivudine, or zidovudine. with moderate or severe hepatic impairment.

Boxed warning: Hypersensitivity Reactions Serious and sometimes fatal hypersensitivity reactions have occurred with abacavir-containing products. Hypersensitivity to abacavir is a multi-organ clinical syndrome. Patients who carry the HLA-B*5701 allele are at a higher risk of experiencing a hypersensitivity reaction to abacavir. Hepatic decompensation, some fatal, has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy and interferon alfa with or without ribavirin. Discontinue abacavir, lamivudine and zidovudine tablets as medically appropriate and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both. Exacerbation of anemia has been reported in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine. Coadministration of ribavirin and zidovudine is not advised.

The most commonly reported adverse reactions (incidence at least 10%) in clinical trials were nausea, headache, malaise and fatigue, and nausea and vomiting. The following adverse reactions are discussed in other sections of the labeling: Serious and sometimes fatal hypersensitivity reactions. Hematologic toxicity, including neutropenia and anemia. Symptomatic myopathy. Lactic acidosis and severe hepatomegaly with steatosis. Exacerbations of hepatitis B. Hepatic decompensation in patients co-infected with HIV-1 and hepatitis C. Exacerbation of anemia in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine. Immune reconstitution syndrome. Lipoatrophy. Myocardial infarction.

Methadone: An increased methadone dose may be required in a small number of patients. Riociguat: The riociguat dose may need to be reduced. Sorbitol: Coadministration of lamivudine and sorbitol may decrease lamivudine concentrations, when possible, avoid chronic coadministration. Agents antagonistic with zidovudine: Concomitant use should be avoided. Hematologic/bone marrow suppressive/cytotoxic agents: May increase the hematologic toxicity of zidovudine.

Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).