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U.S. Department of Health and Human Services


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Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) [albumin-bound] July 2008

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

Summary View

Sections Modified


  • Adverse Event Experiences by Body System
    • Hypersensitivity Reactions (HSRs)
      • ...During postmarketing surveillance, rare occurrences of severe hypersensitivity reactions have been reported with Abraxane. The use of Abraxane in patients previously exhibiting hypersensitivity to paclitaxel injection or human albumin has not been studied. Patients who experience a severe hypersensitivity reaction to Abraxane should not be rechallenged with the drug.


The July 2008 label not available at this site.