Pegaspargase

What is Pegaspargase?

• Pegaspargase (Oncaspar) is an asparagine specific enzyme used with other drugs to treat acute lymphoblastic leukemia (ALL).
• It is used in patients whose cancer has not already been treated or who cannot be treated with asparaginase.
• It is also being studied in the treatment of other types of cancer.
• Oncaspar is a form of the drug asparaginase that is linked to a substance called PEG, which makes the drug stay in the body longer.

Pegaspargasa

What are the uses of this medicine?

Pegaspargase (Oncaspar) is used for the treatment of pediatric and adult patients with:

• First-line acute lymphoblastic leukemia
• Acute lymphoblastic leukemia and hypersensitivity to asparaginase

How does this medicine work?

• Oncaspar is a form of the drug asparaginase that is linked to a substance called PEG, which makes the drug stay in the body longer.
• Asparaginase is an enzyme that breaks down the amino acid asparagine and may block the growth of cancer cells that need asparagine to grow.
• The pharmacological effect of Oncaspar is thought to be based on the killing of leukemic cells due to depletion of plasma asparagine.
• It is a type of protein synthesis inhibitor.
• Also called PEG-asparaginase and pegaspargase.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• History of serious hypersensitivity reactions, including anaphylaxis, to Oncaspar or to any of the excipients
• History of serious thrombosis with prior L-asparaginase therapy
• History of pancreatitis, including pancreatitis related to prior L-asparaginase therapy
• History of serious hemorrhagic events with prior L-asparaginase therapy

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• Pegaspargase may increase the risk of glucocorticoid-induced toxicities.

Is this medicine FDA approved?

• Pegaspargase was approved for medical use in the United States in 1994.

How should this medicine be used?

Premedicate patients with acetaminophen, an H-1 receptor blocker (such as diphenhydramine), and an H-2 receptor blocker (such as famotidine) 30-60 minutes prior to administration of Oncaspar.

Recommended dosage: Patients 21 Years of Age or Younger:

• The recommended dose of Oncaspar for patients up to and including 21 years of age is 2,500 International Units/m2 intramuscularly or intravenously no more frequently than every 14 days.

Patients More Than 21 Years of Age:

• The recommended dose of Oncaspar for adult patients more than 21 years of age is 2,000 International Units/m2 intramuscularly or intravenously no more frequently than every 14 days.

Administration:

• Administered intramuscularly or intravenously no more frequently than every 14 days.
• For intravenous administration, give over a period of 1 to 2 hours in 100 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP through an infusion that is already running.
• Do not administer Oncaspar if drug has been frozen, stored at room temperature for more than 48 hours, or shaken or vigorously agitated.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 3,750 International Units/5 mL (750 International Units/mL) solution in a single-dose vial.

This medicine is available in fallowing brand namesː

• Oncaspar

What side effects can this medication cause?

The most common side effects of this medicine include:

• hypoalbuminemia
• elevated transaminase
• febrile neutropenia
• hypertriglyceridemia
• hyperglycemia
• bilirubin increased
• pancreatitis
• abnormal clotting studies
• embolic and thrombotic events
• hypersensitivity

What special precautions should I follow?

• Anaphylaxis and serious hypersensitivity reactions can occur in patients receiving Oncaspar. Observe patients for 1 hour after administration. Discontinue Oncaspar in patients with serious hypersensitivity reactions.
• Serious thrombotic events, including sagittal sinus thrombosis can occur in patients receiving Oncaspar. Discontinue Oncaspar in patients with serious thrombotic events.
• Pancreatitis can occur in patients receiving Oncaspar. Evaluate patients with abdominal pain for pancreatitis. Discontinue Oncaspar in patients with pancreatitis.
• Glucose intolerance can occur in patients receiving Oncaspar. Monitor serum glucose.
• Increased prothrombin time, increased partial thromboplastin time, and hypofibrinogenemia can occur in patients receiving Oncaspar. Discontinue Oncaspar for severe or life-threatening hemorrhage. Evaluate for etiology and treat.
• Hepatotoxicity and abnormal liver function, including elevations of transaminase, bilirubin (direct and indirect), reduced serum albumin, and plasma fibrinogen can occur. Monitor for toxicity through recovery from cycle. Discontinue Oncaspar for severe liver toxicity.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• increase in liver enzymes
• rash

Management of overdosage:

• There is no specific antidote for Oncaspar overdosage.
• In case of overdose, monitor patients closely for signs and symptoms of adverse reactions, and appropriately manage with symptomatic and supportive treatment.

Can this medicine be used in pregnancy?

• Oncaspar can cause fetal harm when administered to a pregnant woman.
• There are no available data on Oncaspar use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• The safety and effectiveness of Oncaspar in the treatment of ALL have been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• PEGASPARGASE

Inactive ingredients:

• SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
• SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
• SODIUM CHLORIDE
• WATER

Who manufactures and distributes this medicine?

Manufactured by:

• Servier Pharmaceuticals LLC, Boston, MA

What should I know about storage and disposal of this medication?

• Store Oncaspar refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
• Do not shake or freeze product.
• Unopened vials may be stored at room temperature (15°C to 25°C [59°F to 77°F]) for no more than 48 hours.

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• Dailymed label info on Pegaspargase
• FDA Pegaspargase

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