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
