Erwinaze is contraindicated in patients with a history of:
- Serious hypersensitivity reactions to Erwinaze, including anaphylaxis
- Serious pancreatitis with prior L-asparaginase therapy
- Serious thrombosis with prior L-asparaginase therapy
- Serious hemorrhagic events with prior L-asparaginase therapy
Warnings and Precautions
After the use of Erwinaze in clinical trials, grade 3 and 4 hypersensitivity reactions have occurred in 5% of patients and anaphylaxis occurred in 0,8% of patients. Administer in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis. If a serious hypersensitivity reaction occurs (including anaphylaxis), discontinue Erwinaze and initiate appropriate therapy
In clinical trials, 4% of patients reported pancreatitis with Erwinaze therapy. Discontinue Erwinaze for severe or hemorrhagic pancreatitis manifested by abdominal pain >72 hours and amylase elevation ≥2.0 x ULN. In case of mild pancreatitis, hold Erwinaze until the signs and symptoms subside and amylase levels return to normal. After resolution, Erwinaze therapy may be resumed.
In clinical trials, 4% of patients reported glucose intolerance, which in some cases may be irreversible. Monitor glucose levels at baseline and periodically during treatment. Administer insulin therapy as necessary in patients with hyperglycemia.
Thrombosis and Hemorrhage
Serious thrombotic events, including sagittal sinus thrombosis have been reported in both E. coli and Erwinia-derived L-asparaginase therapy. Discontinue Erwinaze for a thrombotic or hemorrhagic event until symptoms resolve; after resolution, Erwinaze therapy may be resumed.
Most Common Adverse Reactions
The most common adverse reactions (incidence 1% or greater) with Erwinaze treatment are systemic hypersensitivity, hyperglycemia, abnormal transaminases, fever, pancreatitis, local reactions, vomiting, nausea, thrombosis, hyperbilirubinemia, abdominal pain/discomfort, and diarrhea.