Serious and sometimes fatal hypersensitivity reactions reported. These hypersensitivity reactions are a multiorgan syndrome usually characterized by a sign or symptom in ≥2 of the following groups: fever, rash, GI (including nausea, vomiting, diarrhea, abdominal pain), constitutional (including generalized malaise, fatigue, aching), and respiratory (including dyspnea, cough, pharyngitis). (See Hypersensitivity Reactions under Cautions.)
Individuals who carry the human leukocyte antigen (HLA)-B*5701 allele are at high risk for a hypersensitivity reaction. Prior to initiation of abacavir therapy, screening for the HLA-B*5701 allele is recommended. Screening also is recommended prior to reinitiation of abacavir therapy in patients who previously tolerated the drug whose HLA-B*5701 status is unknown. (See Hypersensitivity Reactions under Cautions.)
Discontinue abacavir as soon as a hypersensitivity reaction is suspected. Permanently discontinue if hypersensitivity cannot be ruled out regardless of the patient’s HLA-B*5701 status, even when other diagnoses are possible.
Do not restart abacavir or any abacavir-containing preparation following a hypersensitivity reaction because more severe symptoms can recur within hours and have included potentially life-threatening hypotension and death. Severe or fatal hypersensitivity reactions can occur within hours after reintroduction of abacavir in patients with no identified history or unrecognized symptoms of abacavir hypersensitivity.
Lactic acidosis and severe hepatomegaly with steatosis (including some fatalities) reported rarely in patients receiving nucleoside reverse transcriptase inhibitors (NRTIs) alone or in conjunction with other antiretrovirals. (See Lactic Acidosis and Severe Hepatomegaly with Steatosis under Cautions.)
The fixed-combination preparation Epzicom® contains 2 NRTIs (abacavir and lamivudine) and the fixed-combination preparation Trizivir® contains 3 NRTIs (abacavir, lamivudine, zidovudine); these are intended only for patients whose regimen would otherwise include abacavir and the other components.
If using Epzicom® or Trizivir®, consider that severe, acute exacerbations of hepatitis B virus (HBV) infection have been reported when lamivudine was discontinued in patients coinfected with HBV and HIV. Closely monitor hepatic function for at least several months following discontinuance of Epzicom® or Trizivir® in patients coinfected with HBV and HIV. If appropriate, initiation of therapy for HBV infection may be warranted.
If using Trizivir®, consider that zidovudine has been associated with hematologic toxicity including neutropenia and severe anemia, particularly in those with advanced HIV infection, and that prolonged zidovudine use has been associated with symptomatic myopathy.
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