Pegaspargase

What is pegaspargase used for?

Pegaspargase is a prescription medicine that is used to treat a type of leukemia.

Description

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.

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.

Before taking pegaspargase, tell your doctor:

• If you are allergic to pegaspargase; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have had bleeding, a blood clot, or an irritated pancreas when using asparaginase in the past.
• If you have liver disease.
• If you are breast-feeding. Do not breast-feed while you take pegaspargase or for 3 months after your last dose.

This is not a list of all drugs or health problems that interact with pegaspargase.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take pegaspargase with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take pegaspargase?

• Tell all of your health care providers that you take pegaspargase. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• If you have high blood sugar (diabetes), talk with your doctor. This medicine may raise blood sugar.
• Check your blood sugar as you have been told by your doctor.
• High triglyceride levels have happened with pegaspargase. Tell your doctor if you have ever had high triglyceride levels.
• Unsafe allergic effects may happen. You will be closely watched by your doctor.
• Severe and sometimes deadly pancreas problem (pancreatitis) has happened with pegaspargase. If you have questions, talk with the doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting pegaspargase. Talk with your doctor.
• Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking pegaspargase and for 3 months after your last dose.
• If you get pregnant while taking pegaspargase or within 3 months after your last dose, call your doctor right away.

How is pegaspargase best taken?

Use pegaspargase as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a muscle or as an infusion into a vein over a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of pegaspargase that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Very bad dizziness or passing out.
• Any unexplained bruising or bleeding.
• Very bad headache.
• Change in eyesight.
• Feeling very sleepy.
• Feeling confused.
• Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.
• Low white blood cell counts have happened with pegaspargase. This may lead to a higher chance of getting an infection. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.

What are some other side effects of pegaspargase?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out pegaspargase?

• If you need to store pegaspargase at home, talk with your doctor, nurse, or pharmacist about how to store it.