"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"...
(pegaspargase) Intravenous -or- Intramuscular Injection
- Patient Information:
Details with Side Effects
Oncaspar® (pegaspargase) is a modified version of the enzyme L-asparaginase. To produce Oncaspar® (pegaspargase) , 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 18.104.22.168) used in the manufacture of Oncaspar® (pegaspargase) is derived from E coli and supplied by Ovation Pharmaceuticals (U.S. License No. 1688) under a shared manufacturing arrangement. Oncaspar® (pegaspargase) 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 umol of ammonia per minute at pH 7.3 and 37°C.
Oncaspar® (pegaspargase) is supplied as a clear, colorless, preservative-free, isotonic sterile solution in phosphate-buffered saline, pH 7.3. Each milliliter contains Oncaspar® (pegaspargase) 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.
What are the possible side effects of pegaspargase (Oncaspar)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
- sudden numbness or weakness, especially on one side of the body;
- sudden headache, confusion, problems with vision, speech, or balance;
- pain or swelling in one or both legs;
- fever, chills, body aches, flu...
What are the precautions when taking pegaspargase (Oncaspar)?
Before using pegaspargase, tell your doctor or pharmacist if you are allergic to it; or to L-asparaginase; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: history of a serious reaction to L-asparaginase (e.g., bleeding, blood clots, pancreatitis), diabetes, clotting/bleeding disorders, liver disease, pancreatitis.
Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.
Wash your hands well to prevent the...
Last reviewed on RxList: 3/2/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Oncaspar Information
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