Risk for hypersensitivity reactions (HSR) characterized by fever &/or rash w/ other symptoms indicating multi-organ involvement. Increased risk for abacavir HSR. Not recommended in patients w/ HLA-B*5701 allele or in patients w/ suspected abacavir HSR during treatment w/ any other abacavir-containing medicinal products. Consider testing for HLA-B*5701 prior to initiating & re-starting abacavir treatment in patients of unknown HLA-B*5701 status; discontinue treatment w/o delay if HSR is suspected; do not restart treatment if HSR cannot be ruled out; misdiagnosis of abacavir HSR as resp disease (eg, pneumonia, bronchitis, pharyngitis), or gastroenteritis. Discontinue treatment in symptomatic hyperlactatemia & metabolic/lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels. Obese women, patients w/ hepatomegaly, hepatitis or other known risk factors for liver disease & hepatic steatosis; patients co-infected w/ hepatitis C & treated w/ α-interferon & ribavirin; suspend treatment in patients who developed clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity. May increase serum lipid & blood glucose levels. HIV-infected patients w/ severe immune deficiency. Evaluate inflammatory symptoms w/o delay & initiate treatment when necessary. Autoimmune disorders (eg, Graves' disease, polymyositis & Guillain-Barre syndrome). Patients co-infected w/ HBV; consider periodic monitoring of liver function tests & HBV replication markers upon discontinuation of therapy. Increased risk of severe & potentially fatal hepatic adverse events in patients w/ chronic hepatitis B or C. Closely observe for opportunistic infections & other HIV-infection complications. Triple nucleoside therapy. Not proven to prevent risk of HIV transmission to others through sexual contact or blood contamination. Risk of MI. Consider the underlying risk of coronary heart disease & minimize all modifiable risk factors (eg, HTN, hyperlipidaemia, DM & smoking). Mitochondrial dysfunction in HIV negative infants exposed
in utero &/or post-natally to nucleoside analogues. Not recommended for use in patients w/ CrCl <50 mL/min. Pregnancy & lactation. Childn <25 kg. Elderly >65 yr.
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