Please call for special Pricing. ONCASPAR- pegaspargase injection, solution
Baxalta US Inc.
1 INDICATIONS AND USAGE
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.
2 DOSAGE AND ADMINISTRATION
2.1 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.
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:
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frozen
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stored at room temperature 15� to 25�C (59� to 77�F) for more than 48 hours
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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.
3 DOSAGE FORMS AND STRENGTHS
3,750 International Units/5 mL solution in a single-use vial.
DESCRIPTION
ONCASPAR (pegaspargase) is L-asparaginase (L-asparagine amidohydrolase) that is covalently conjugated to monomethoxypolyethylene glycol (mPEG). L-asparaginase is a tetrameric enzyme that is produced endogenously by E. coli and consists of identical 34.5 kDa subunits. Approximately 69 to 82 molecules of mPEG are linked to L-asparaginase; the molecular weight of each mPEG molecule is about 5 kDa. ONCASPAR activity is expressed in International Units. One International Unit of L-asparaginase is defined as the amount of enzyme required to generate 1 micromole 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 750 � 150 International Units of pegaspargase, dibasic sodium phosphate, USP (5.58 mg), monobasic sodium phosphate, USP, (1.20 mg) and sodium chloride, USP (8.50 mg) in water for injection, USP.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
The mechanism of action of ONCASPAR is thought to be based on selective killing of leukemic cells due to depletion of plasma asparagine. Some leukemic cells are unable to synthesize asparagine due to a lack of asparagine synthetase and are dependent on an exogenous source of asparagine for survival. Depletion of asparagine, which results from treatment with the enzyme L-asparaginase, kills the leukemic cells. Normal cells, however, are less affected by the depletion due to their ability to synthesize asparagine.
