Generic Name: Pegaspargase (peg-eh-SPARG-ase)
Trade Name: Oncaspar®
How is this drug used? Pegaspargase is FDA approved for the treatment of acute lymphocytic leukemia in patients who have developed hypersensitivity to L-asparaginase. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.
What is the mechanism of action? Pegaspargase is a modified form of the enzyme L-asparaginase. Pegaspargase has been formulated to remain active in the body for a longer period of time than asparaginase. Pegaspargase produces its anti-cancer effects in the same manner as asparaginase, by “breaking down” asparagine, a substance normally found in the body that is involved in biological processes that are essential for cells to live. Healthy cells are able to create asparagine for themselves; however, leukemic cancer cells are not able to create asparagine for themselves. Therefore, the depletion of asparagine by pegasparagase deprives tumor cells of the amino acid needed for protein synthesis, thereby killing cancer cells. Because healthy cells make asparagine for themselves, they do not tend to be as affected by pegasparagase.
How is pegaspargase given (administered)? Pegaspargase is administered either into a vein (intravenous) or into a muscle (intramuscular), and the dose depends on several factors, including the condition being treated, the size of the patient, the particular treatment regimen being used, and the overall health of the patient.
Patients may experience an allergic reaction to pegaspargase. Patients experiencing difficulty breathing, closing of throat, rash, fever, facial swelling, lightheadedness or dizziness, or hives should tell their healthcare provider immediately.
How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with pegaspargase. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy. In addition, pancreatic function, blood clotting factors and blood sugar levels may be monitored. Inflammation of the pancreas (pancreatitis) is a side effect of treatment with pegaspargase. Patients experiencing severe abdominal pain should contact their healthcare provider.
What are the most common (occur in 30% or more of patients) side effects of treatment with pegaspargase?
• Changes in liver function tests, liver damage
• Nausea and vomiting
• Abdominal pain
• Lack of appetite
• Fluid retention resulting in swelling
• Generalized weakness
• Pain at injection site
• Allergic-type symptoms – hives, rash, closing of throat, difficulty breathing, lightheadedness, low blood pressure, fever, facial swelling
• Swelling of the lip
What are the less common side effects of treatment with pegaspargase?
• Abnormalities in blood sugar levels
• Difficulty breathing
• Inflammation of the pancreas
• Change in levels of blood clotting factors
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• Eat small meals frequently to help alleviate nausea.
Are there any special precautions patients should be aware of before starting treatment?
• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
When should patients notify their physician?
• Severe abdominal pain
• Swelling of ankles or feet
• Yellowing of skin or eyes
• Sudden weight gain
• Fluid accumulation in the abdomen
• Allergic-type symptoms – hives, rash, closing of throat, difficulty breathing, lightheadedness, swelling of lips or mouth
• Signs of infection – redness, swelling, tenderness, pus
• Severe and prolonged fatigue
• Unexplained bleeding – blood in the urine, bruising, black tarry stool, bloody nose, etc.
• Flu or cold-like symptoms – fever, chills, sore throat, cough
• Severe or persistent diarrhea
• Noticeable changes in heart rate or rhythm, chest pain
• Seizures or tremors
• Severe or persistent nausea and vomiting
• Difficulty breathing or persistant cough
• Burning, pain or redness at the administration site
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.
As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.
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