Label Changes for:

Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), 100 milligram vial

September 2012

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

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

 

September 2012

5 WARNINGS AND PRECAUTIONS

5.3 Hypersensitivity
  • Severe and sometimes fatal hypersensitivity reactions, including anaphylactic reactions, have been reported. Patients who experience a severe hypersensitivity reaction to ABRAXANE should not be re-challenged with this drug.

6 ADVERSE REACTIONS

6.2 Postmarketing Experience
  • Respiratory: ......added pneumonitis
  • Vision Disorder: ..... added cystoid macular edema (CME)

17 PATIENT COUNSELING INFORMATION

  • added..... Patients must be informed that hypersensitivity reactions may occur, which could be severe and sometimes fatal. 

 

 

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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