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Data From Landmark Study Evaluating Gender Differences in Response to an HIV Therapy Published in Annals of Internal Medicine
Date:9/20/2010

The potential for HIV cross-resistance among protease inhibitors has not been fully explored in PREZISTA/r-treated patients

Use in Specific Populations

  • Hepatic impairment: 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
  • 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/r arm through 96 weeks were diarrhea (8%), headache (6%), abdominal pain (5%), and rash (5%)
  • 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/r 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 use of PREZISTA/r. Please see accompanying full Prescribing Information for more details. Full prescribing information is also available at www.PREZISTA.com.

    You are encouraged to report negative side effects of prescription drugs to the FDA.  Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

    About Tibotec TherapeuticsTibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P., headquartered in Titusville, NJ, is dedicated to delivering innovative virology therapeutics that help healthcare professionals address serious
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    SOURCE Tibotec Therapeutics
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