July 26, 2016
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How Supplied


First Line Acute Lymphoblastic Leukemia (ALL)

Oncaspar® is indicated as a component of a multi-agent chemotherapeutic regimen for the first line treatment of patients with ALL.

Acute Lymphoblastic Leukemia And Hypersensitivity To Asparaginase

Oncaspar® is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with ALL and hypersensitivity to native forms of L-asparaginase.


Recommended Dose

The recommended dose of Oncaspar® is 2,500 International Units/m² intramuscularly or intravenously. Oncaspar® should be administered no more frequently than every 14 days.

Instructions For Administration

When Oncaspar® is administered intramuscularly, the volume at a single injection site should be limited to 2 mL. If the volume to be administered is greater than 2 mL, multiple injection sites should be used. Oncaspar® does not contain a preservative. Use only one dose per vial; discard unused product.

When administered intravenously, Oncaspar® should be given over a period of 1 to 2 hours in 100 mL of sodium chloride or dextrose injection 5%, through an infusion that is already running. After the solution is diluted for intravenous use, the solution should be used immediately. If immediate use is not possible, the diluted solution should be stored refrigerated at 2°C to 8°C (36°F to 46°F). Storage after dilution should not exceed 48 hours from the time of preparation to completion of administration. Protect infusion bags from direct sunlight.

Preparation And Handling Precautions

Do not administer Oncaspar® if drug has been:

  • frozen
  • stored at room temperature 15° to 25°C (59° to 77°F) for more than 48 hours
  • shaken or vigorously agitated [see HOW SUPPLIED/Storage and Handling]

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 vial.


Dosage Forms And Strengths

3,750 International Units/5 mL solution in a single-use vial.

Storage And Handling

Oncaspar® (pegaspargase) is supplied as a sterile solution in Type I single-use vials containing 3,750 International Units of L-asparaginase per 5 mL solution (NDC 54482-301-01).

Store Oncaspar® under refrigeration at 2°C to 8°C (36°F to 46°F). Do not shake or freeze product. Protect from light. Do not use Oncaspar® after the expiration date on the vial.

Manufactured by Sigma-Tau Pharmaceuticals, Inc., Gaithersburg, MD 20878. Revised: April 2014

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 5/2/2014

How Supplied

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.


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