ELSPAR - asparaginase injection, powder, lyophilized, for solution 
Lundbeck Inc.
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Elspar safely and effectively.
See full prescribing information for Elspar.
ELSPAR ® (asparaginase)
For injection, intravenous or intramuscular
Initial U.S. Approval: 1978
INDICATIONS AND USAGE
Elspar is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) (1)
DOSAGE AND ADMINISTRATION
6,000 International Units/m2 intramuscularly (IM) or intravenously (IV) three times a week (2.1)
Reconstitute in volume appropriate for the intended route of administration:
   For IM administration, reconstitute in 2 mL (2.3)
   For IV administration, reconstitute in 5 mL (2.3)
For IM administration, limit the volume at a single injection site to 2 mL; if greater than 2 mL, use multiple injection sites (2.2).
For IV administration, give over ≥ 30 min through side arm of an infusion of Sodium Chloride Injection or Dextrose Injection 5% (D5W) (2.2).
Use reconstituted Elspar within eight hours (2.3).
DOSAGE FORMS AND STRENGTHS
10,000 International Units as lyophilized powder in single-use vial.(3)
CONTRAINDICATIONS
Serious allergic reactions to Elspar or other Escherichia coli-derived L-asparaginases (4)
Serious thrombosis with prior L-asparaginase therapy (4)
Pancreatitis with prior L-asparaginase therapy (4)
Serious hemorrhagic events with prior L-asparaginase therapy (4)
WARNINGS AND PRECAUTIONS
Anaphylaxis and other serious allergic reactions can occur. Observe patients for one hour after administration. Discontinue Elspar in patients with serious allergic reactions. (5.1)
Serious thrombotic events, including sagittal sinus thrombosis, can occur. Discontinue Elspar in patients with serious thrombotic events. (5.2)
Pancreatitis, in some cases fulminant or fatal, can occur. eva luate patients with abdominal pain for pancreatitis. Discontinue Elspar in patients with pancreatitis. (5.3)
Glucose intolerance, in some cases irreversible, can occur. Monitor serum glucose. (5.4)
Coagulopathy can occur. Perform appropriate monitoring. (5.5)
Hepatotoxicity including hepatic failure, liver disorder and a variety of liver function abnormalities have been reported (5.6)
ADVERSE REACTIONS
Most common adverse reactions are allergic reactions (including anaphylaxis), hyperglycemia, pancreatitis, central nervous system (CNS) thrombosis, coagulopathy, hyperbilirubinemia, and elevated transaminases. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck Inc. at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
See 17 for PATIENT COUNSELING INFORMATION 
Revised: 02/2010
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FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed 
1  INDICATIONS AND USAGE
2  DOSAGE AND ADMINISTRATION
2.1  Recommended Dose
2.2  Instructions for Administration
2.3  Preparation and Handling Precautions
3  DOSAGE FORMS AND STRENGTHS
4  CONTRAI