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____________________________________________________________________________________ Indication Important Safety Information Serious allergic reactions can occur in patients receiving ELSPAR. The risk of serious allergic reactions is higher in patients with prior exposure to Elspar or other Escherichia coli-derived L-asparaginases. Patients should be observed for one hour after administration of ELSPAR in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis. Serious thrombotic events (including sagittal sinus thrombosis), pancreatitis (in some cases fulminant or fatal), and glucose intolerance can occur. In some cases, glucose intolerance is irreversible. Monitor serum glucose. CNS hemorrhages have been observed. Monitor coagulation parameters at baseline and periodically during and after treatment. Initiate treatment with fresh-frozen plasma to replace coagulation factors in patients with severe or symptomatic coagulopathy. The following serious adverse reactions occur with ELSPAR treatment: Anaphylaxis and serious allergic reactions, serious thrombosis, pancreatitis, glucose intolerance and coagulopathy. The most common adverse reactions with ELSPAR are allergic reactions (including anaphylaxis), hyperglycemia, pancreatitis, central nervous system (CNS) thrombosis, coagulopathy, hyperbilirubinemia, and elevated transaminases. For more information, please see Full Prescribing Information. ® Trademark of Lundbeck Inc., Deerfield, IL 60015, U.S.A. |
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