Oncaspar label

Oncaspar

Oncaspar Recall

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Side Effects & Adverse Reactions

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

1.1 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.

1.2 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.

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History

There is currently no drug history available for this drug.

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Other Information

Oncaspar® (pegaspargase) is a modified version of the enzyme L-asparaginase. To produce Oncaspar®, L-asparaginase is modified by covalently conjugating units of monomethoxypolyethylene glycol (PEG), molecular weight of 5,000, to the enzyme, forming the active ingredient PEG-L-asparaginase. The L‑asparaginase (L-asparagine amidohydrolase, type EC-2, EC 3.5.1.1) used in the manufacture of Oncaspar® is derived from E. coli and supplied by Ovation Pharmaceuticals (U.S. License No. 1688) under a shared manufacturing arrangement. Oncaspar® activity is expressed in International Units (IU) according to the recommendation of the International Union of Biochemistry. One IU of L-asparaginase is defined as that amount of enzyme required to generate 1 µmol of ammonia per minute at pH 7.3 and 37°C.

Oncaspar® is supplied as a clear, colorless, preservative-free, isotonic sterile solution in phosphate-buffered saline, pH 7.3. Each milliliter contains Oncaspar® 750 IU ± 20% (based on specific activity of at least 85 IU per milligram protein), 1.20 mg monobasic sodium phosphate, USP, 5.58 mg dibasic sodium phosphate, USP, and 8.50 mg sodium chloride, USP, in water for injection, USP.

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Oncaspar Manufacturers

  • Enzon Pharmaceuticals, Inc.
    Oncaspar | Enzon Pharmaceuticals, Inc.
    No Recall

    Oncaspar | Enzon Pharmaceuticals, Inc.

    Oncaspar | Enzon Pharmaceuticals, Inc.
    2.1 Recommended Dose

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

    2.2 Instructions for Administration

    When Oncaspar® 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® 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.

    2.3 Preparation and Handling Precautions

    Do not administer Oncaspar® 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/Storage and Handling (16)]

    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.

  • Sigma-tau Pharmaceuticals, Inc.
    Oncaspar | Sigma-tau Pharmaceuticals, Inc.
    No Recall

    Oncaspar | Sigma-tau Pharmaceuticals, Inc.

    Oncaspar | Sigma-tau Pharmaceuticals, Inc.
    2.1 Recommended Dose   The recommended dose of Oncaspar ® is 2,500 International Units/m 2 intramuscularly or intravenously. Oncaspar ® should be administered no more frequently than every 14 days. 2.2 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. 2.3 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 ( 16) ]   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.
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