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Oncaspar

"The U.S. Food and Drug Administration today approved Erwinaze (asparaginase Erwinia chrysanthemi) to treat patients with acute lymphoblastic leukemia (ALL), who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pega"...

Oncaspar

Oncaspar

INDICATIONS

First Line Acute Lymphoblastic Leukemia (ALL)

Oncaspar® (pegaspargase) 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® (pegaspargase) 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.

DOSAGE AND ADMINISTRATION

Recommended Dose

The recommended dose of Oncaspar® (pegaspargase) is 2,500 IU/m2 intramuscularly (IM) or intravenously (IV). Oncaspar® (pegaspargase) should be administered no more frequently than every 14 days.

Instructions for Administration

When Oncaspar® (pegaspargase) is administered IM, 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.

When administered IV, Oncaspar® (pegaspargase) 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.

Preparation and Handling Precautions

Do not administer Oncaspar® (pegaspargase) if drug has been:

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

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.

HOW SUPPLIED

Dosage Forms And Strengths

3,750 IU/5 mL single-use vial

Dosage Form

NDC 57665-002-02

3,750 IU/5 mL single-use vial individually packaged in a carton

Storage and Handling

Keep refrigerated at +2°C to +8°C (36°F to 46°F).

Use only one dose per vial; do not re-enter the vial. Discard unused portions. Do not save unused drug for later administration.

Do not administer Oncaspar® (pegaspargase) if the drug:

  • has been frozen
  • has been stored at room temperature (+15°C to +25°C: 59°F to 77°F) for more than 48 hours
  • has been shaken or vigorously agitated
  • is cloudy, discolored, and precipitate is present.

Enzon Pharmaceuticals, Inc. Bridgewater NJ 08807.

Last reviewed on RxList: 3/2/2009
This monograph has been modified to include the generic and brand name in many instances.

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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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