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FDA Approves Label Update for PREZISTA® to Include 192-Week Data in HIV-1-Infected Adult Patients Starting Treatment
Date:10/21/2011

ceiving protease inhibitors. Initiation or dose adjustments of insulin or oral hypoglycemic agents may be required. A causal relationship between protease inhibitors and these events has not been established
  • Fat Redistribution: Redistribution and/or accumulation of body fat have been observed in patients receiving 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
  • Resistance/Cross Resistance: The potential for HIV-1 cross-resistance among protease inhibitors has not been fully explored in PREZISTA/ritonavir-treated patients

  • Use in Specific Populations

  • Hepatic Impairment: PREZISTA/ritonavir is not recommended for use in patients with severe hepatic impairment. There are no pharmacokinetic or safety data available in patients with severe hepatic impairment
  • Pregnancy: PREZISTA 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

  • In treatment-naive adult patients, the most common adverse drug reactions (greater than or equal to 5%) reported of at least moderate intensity (greater than or equal to Grade 2) in the PREZISTA/ritonavir arm through 192 weeks were diarrhea (9%), headache (7%), abdominal pain (6%), and rash (6%)
  • In treatment-experienced adult patients, the most common adverse drug reactions (greater than or equal to 5%) reported of at least moderate intensity (greater than or equal to Grade 2) in the PREZISTA/ritonavir arm through 96 weeks were diarrhea (14%), nausea (7%), rash (7%), abdominal pain (6%), and vomiting (5%)

  • This is not a complete list of all adverse drug reactions reported with the us
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    SOURCE Janssen Therapeutics, Division of Janssen Products, LP
    Copyright©2010 PR Newswire.
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