Elspar is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL ).

Recommended Dose

The recommended dose of Elspar is 6, 000 International Units/m² intramuscularly (IM) or intravenously (IV) three times a week.

Instructions for Administration

When Elspar is administered IM, the volume at a single injection site should be limited to 2 mL. If a volume greater than 2 ml is to be administered, two injection sites should be used.

When administered IV, give Elspar over a period of not less than thirty minutes through the side arm of an infusion of Sodium Chloride Injection or Dextrose Injection 5% (D₅W).

Preparation and Handling Precautions

For IM administration, reconstitute Elspar by adding 2 ml Sodium Chloride Injection to the 10, 000 unit vial. Withdraw volume of reconstituted Elspar containing calculated dose into sterile syringe. For IV administration, reconstitute Elspar by adding 5 ml Sterile Water for Injection or Sodium Chloride Injection to the 10, 000 unit vial. Withdraw volume of reconstituted Elspar containing calculated dose into sterile syringe.

Use reconstituted Elspar within eight hours.

Parenteral drug products should be inspected visually for particulate matter, cloudiness or discoloration prior to administration, whenever solution and container permit. If any of these are present, discard the solution. However, occasionally, a very small number of gelatinous fiber-like particles may develop on standing. Filtration through a 5.0 micron filter during administration will remove the particles with no resultant loss in potency.

Dosage Forms And Strengths

10, 000 International Units as lyophilized powder in single-use vial.

Storage And Handling

Dosage Form

NDC 67386-411-51

10, 000 International Units as lyophilized powder in single dose vial individually packaged in a carton.

Storage and Handling

Keep vials refrigerated at 2-8°C (36-46°F).

Elspar does not contain a preservative. Store unused, reconstituted solution at 2-8°C (36-46°F) and discard after eight hours, or sooner if it becomes cloudy.

Ovation Pharmaceuticals, Inc., Deerfield, IL 60015, U.S.A. Revised: 3/2007. FDA revision date: 3/30/2007

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