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U.S. Department of Health and Human Services

Safety

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Erwinaze (asparaginase Erwinia chrysanthemi)

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

 

March 2014

Summary View

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions
  • Grade 3 and 4 hypersensitivity reactions after the use of ERWINAZE have occurred in 5% of patients in clinical trials.
  • Anaphylaxis after the use of ERWINAZE has occurred in 0.8% of patients in clinical trials
Glucose Intolerance
  • Glucose intolerance has been reported with ERWINAZE therapy in 4% of patients in clinical trials