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PREZISTA(R) Now Available for Pediatric Patients Six Years of Age and Older as part of HIV Combination Therapy
Date:2/11/2009

d be monitored during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases, especially during the first several months of PREZISTA/r treatment. Evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients on PREZISTA/r should prompt consideration of interruption or discontinuation of treatment.

  • Cases of severe skin rashes and Stevens-Johnson syndrome have been reported in subjects receiving PREZISTA. PREZISTA should be discontinued if severe rash develops
  • PREZISTA should be used with caution in patients with known sulfonamide allergy.
  • New-onset or exacerbations of preexisting diabetes mellitus, hyperglycemia, and increased bleeding in hemophiliacs have been reported in patients receiving 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.
  • 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.
  • The potential for HIV cross-resistance among protease inhibitors has not been fully explored in PREZISTA/r-treated patients.
  • PREZISTA/r 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.
  • PREZISTA should be used during pregnancy only if the potential b
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SOURCE Tibotec Therapeutics
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