Erwinaze (asparaginase Erwinia chrysanthemi)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS AND PRECAUTIONS
- 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 has been reported with ERWINAZE therapy in 4% of patients in clinical trials