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FDA Approves New Dosage Strength for INTELENCE®
Date:1/3/2011

sitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema)

  • Monitor clinical status including liver transaminases, and initiate appropriate therapy  
  • Delay in stopping INTELENCE treatment after the onset of severe rash may result in a life-threatening reaction
  • Fat Redistribution: Redistribution and/or accumulation of body fat have been observed in patients receiving antiretroviral (ARV) therapy. The causal relationship, mechanism, and long-term consequences of these events have not been established
  • Immune Reconstitution Syndrome: has been reported in patients treated with ARV therapy, including INTELENCE

  • Use in Specific Populations

  • Hepatic Impairment: INTELENCE should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) as pharmacokinetics of INTELENCE have not been evaluated in these patients
  • Pregnancy Category B:  INTELENCE should be used during pregnancy only if the potential benefit justifies the potential risk. No adequate and well-controlled studies have been conducted in pregnant women

  • Adverse Reactions

  • The most common adverse drug reactions (> or = 2%) of at least moderate intensity (> or = Grade 2) reported in patients taking INTELENCE and that occurred at a higher rate compared with placebo were rash (10% vs 3%) and peripheral neuropathy (4% vs 2%)

  • Drug Interactions

  • INTELENCE should not be coadministered with the following ARVs: tipranavir/ritonavir, fosamprenavir/ritonavir, atazanavir/ritonavir, full-dose ritonavir (600 mg bid), protease inhibitors administered without low-dose ritonavir, and other NNRTIs
  • INTELENCE should not be co-administered with carbamazepine, phenobarb
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  • SOURCE Tibotec Therapeutics
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