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
Serious Hypersensitivity Reactions, Including Anaphylaxis
In clinical trials, 5% of patients had serious hypersensitivity reactions including anaphylaxis after Erwinaze use. Discontinue Erwinaze if a serious hypersensitivity reaction occurs and initiate appropriate therapy. Administer in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis.
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, 2% of patients reported glucose intolerance, which may be irreversible in some cases. 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%) with Erwinaze treatment were serious hypersensitivity reactions, including anaphylaxis, pancreatitis, abnormal transaminases, coagulation abnormalities including thrombosis and hemorrhage, nausea and vomiting, and hyperglycemia.
Pregnancy category C. It is not known whether Erwinaze can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Erwinaze should be given to a pregnant woman only if clearly needed.
It is not known whether Erwinaze is secreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
The safety and efficacy of Erwinaze has not been studied in geriatric patients.