Label Changes for:

Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable

December 2011

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2011

 

 

ADVERSE REACTIONS

  • pyrexia, dehydration, pancytopenia, congestive heart failure, and left ventricular dysfunction
  • Stevens-Johnson syndrome, toxic epidermal necrolysis and extravasation
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