"The U.S. Food and Drug Administration today expanded the approved uses of Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound) to treat patients with late-stage (metastatic) pancreatic cancer.
Elspar is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL).
DOSAGE AND ADMINISTRATION
The recommended dose of Elspar is 6,000 International Units/m² intramuscularly (IM) or intravenously (IV) three times a week.
Instructions for Administration
W hen 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. Discard unused portion.
W hen 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). Discard unused portion.
Preparation and Handling Precautions
For IM administration, reconstitute Elspar by adding 2 mL Sodium Chloride Injection to the 10,000 unit vial. W ithdraw volume of reconstituted Elspar containing calculated dose into sterile syringe. The reconstituted solution contains 5,000 international units (IU)/mL.
For IV administration, reconstitute Elspar by adding 5 mL Sterile W ater for Injection or Sodium Chloride Injection to the 10,000 unit vial. W ithdraw volume of reconstituted Elspar containing calculated dose into sterile syringe. The reconstituted solution contains 2,000 IU/mL.
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.
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.
Lundbeck, Deerfield, IL 60015, U.S.A. Revised: July 2013
Last reviewed on RxList: 7/26/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Elspar Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get the latest treatment options.