Elspar is supplied as a white lyophilized plug or powder in a sterile 10 mL vial containing 10,000 I.U. of asparaginase.
Indications and Usage
ELSPAR® (asparaginase) is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL).
Important Safety Information
ELSPAR is contraindicated in patients with serious allergic reactions to ELSPAR or other Escherichia coli-derived L-asparaginase, serious thrombosis with prior L-asparaginase therapy, pancreatitis with prior L-asparaginase therapy and in patients with serious hemorrhagic events with prior L-asparaginase therapy.
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.
Important Contact Information
Dial 911 if you are experiencing a medical emergency. Please visit Customer Support for important contact information relating to our products, including:
- Medical information
- Drug safety information
- Product ordering information
You are encouraged to report negative side effects to the FDA.
Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.
