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 3.5.1.1) 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.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: severe stomach/abdominal pain, signs of an infection (e.g., fever), increased thirst/urination, easy bruising/bleeding, dark urine, yellowing eyes/skin, pain/redness/swelling/numbness/tingling of the arms or legs, change in the amount of urine.

Get medical help right away if any of these rare but very serious side effects occur: sudden shortness of breath, chest pain, severe headache, seizures, slurred speech, confusion, vision changes, weakness on one side of the body.

A very serious allergic reaction to this drug can occur. Get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of a serious reaction to L-asparaginase (e.g., bleeding, blood clots, pancreatitis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: 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 spread of infections.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages because they may make you dizzy and increase the risk of liver disease.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may infrequently make your blood sugar level rise, causing or worsening diabetes. Tell your doctor immediately if you develop symptoms of high blood sugar such as increased thirst and urination. If you already have diabetes, be sure to check your blood sugar level regularly as directed by your doctor.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.