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Abacavir

    Brands

    DEA Class; Rx

    Common Brand Names; Ziagen

    • HIV, NRTIs; 
    • Antiretroviral Agents

    Synthetic guanosine nucleoside reverse transcriptase inhibitor (NRTI)
    Indicated for the treatment of human immunodeficiency virus (HIV) infection
    Associated with fatal hypersensitivity reactions during initial treatment and with reintroduction of therapy

    Indicated for treatment of HIV infection in combination with other antiretroviral agents

    Prior hypersensitivity reaction to abacavir

    Presence of HLA-B*5701 allele

    Moderate or severe hepatic impairment

    • Nausea (17-19%)
    • Headache (9-13%)
    • Malaise/fatigue (12%)
    • Nausea & vomiting (10%)
    • Hypersensitivity reaction (2-8%)
    • Diarrhea (5-7%)
    • Musculoskeletal pain (5-7%)
    • Hypertriglyceridemia (6%)
    • Hepatic: AST increased (6%)
    • Depression (4-6%)
    • Fever/chills (3-6%)
    • Viral respiratory infections (5%)
    • Ear/nose/throat infections (4-5%)
    • Rash (4-5%)
    • Anxiety (3-5%)
    • Thrombocytopenia (1%)

    Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with nucleoside analogs, including abacavir; a majority of these cases have been in women; female gender and obesity may be risk factors; suspend dosing in those who develop clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity, which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations

    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, Graves 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

    Available data from the APR show no difference in the overall risk of birth defects for abacavir compared with the background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population

    Abacavir is present in human milk; there is no information on effects of abacavir on breastfed infant or effects of drug on milk production

    Adults

    600 mg/day PO.

    Geriatric

    600 mg/day PO.

    Adolescents

    16 mg/kg/day PO (Max: 600 mg/day).

    Children

    16 mg/kg/day PO (Max: 600 mg/day).

    Infants

    3 to 11 months: 16 mg/kg/day PO.
    1 to 2 months: Safety and efficacy have not been established; however, doses up to 8 mg/kg/day PO have been used off-label.

    Neonates

    Safety and efficacy have not been established; however, doses up to 4 mg/kg/day PO have been used off-label.

    Abacavir

    oral solution

    • 20mg/mL

    tablet

    • 300mg