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U.S. Department of Health and Human Services

Safety

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Reyataz (atazanavir sulfate) Capsules September 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Rash

ADVERSE REACTIONS

  • Clinical Trial Experience in Adults
  • Treatment-Emergent Adverse Reactions in Treatment-Naive Patients
  • Initial Section
  • Table 4
  • Laboratory Abnormalities in Treatment-Naive Patients
  • Table 7
  • Lipids, Change from Baseline in Treatment-Naive Patients
  • Table 10
  • Patients Co-infected With Hepatitis B and/or Hepatitis C Virus

PATIENT PACKAGE INSERT

  • How should I take Reyataz (atazanavir sulfate)?
  • For adults who have never taken anti-HIV medicines before...

WARNINGS AND PRECAUTIONS

Rash

In controlled clinical trials, rash (all grades, regardless of causality) occurred in approximately 20% of patients treated with Reyataz (atazanavir sulfate). The median time to onset of rash in clinical studies was 7.1 weeks and the median duration of rash was 1.3 weeks. Rashes were generally mild-to-moderate maculopapular skin eruptions. Treatment-emergent adverse reactions of moderate or severe rash (occurring at a rate of >2%) are presented for the individual clinical studies [see Adverse Reactions (6.1)]. Dosing with Reyataz was often continued without interruption in patients who developed rash. The discontinuation rate for rash in clinical trials was <1%...
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