Pegaspargase Application Scope

Used as part of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and adult patients.

Pegaspargase Characteristics

Ingredients:Pegaspargase (pegylated L-asparaginase) (active) in a buffered aqueous solution (no preservatives)
Properties:
- It is a PEGylated form of E. coli L-asparaginase (i.e. enzyme conjugated with polyethylene glycol)
- Enzyme activity: hydrolyzes L-asparagine to aspartate + ammonia, depleting plasma asparagine, thus starving leukemic cells that cannot synthesize asparagine efficiently
Packaging Specification: 3,750 International Units / 5 mL (i.e. 750 IU/mL) single-dose vial
Storage:
- Store refrigerated, between 2 °C and 8 °C (do not freeze)
- Do not use if frozen, shaken vigorously, or stored > 48 hours at room temperature
Expiry Date: As per manufacturer’s label (typical shelf life as specified on vial/box) — not uniformly published in public summary; refer to the specific batch label.
Executive Standard: Depends on the country
Approval Number: National Drug Approval Number H20090015
Date of Revision: Last major revision in FDA label: November 2021
Manufacturer: Jiangsu Hengrui Medicine Co., Ltd.

Guidelines for the Use of Pegaspargase

Dosage and Administration:
- Recommended Dose:
  - For patients ≤ 21 years: 2,500 IU/m² every 14 days
  - For patients > 21 years: 2,000 IU/m² every 14 days
- Administration:
  - Intramuscular (IM) injection or intravenous (IV) infusion
  - For IV: infuse over 1–2 hours in 100 mL of 0.9% NaCl or 5% dextrose, can be given via an already-running infusion line
  - IM: limit volume per injection site (≤ 2 mL in children, ≤ 3 mL in adults; if larger, split into multiple sites)
- Missed Dose:
  
  Not specifically detailed in public prescribing summary. Typically, dosing is scheduled every 14 days; for missed dose, physician judgment is required (e.g. administer as soon as possible within protocol allowances).
Adverse Reactions:
- Common Adverse Reactions:
  - Hypoalbuminemia
  - Elevated liver transaminases
  - Hyperglycemia
  - Hypertriglyceridemia
  - Febrile neutropenia
  - Increased bilirubin
  - Pancreatitis
  - Abnormal clotting studies
  - Hypersensitivity / allergic reactions
- Serious Adverse Reactions:
  - Anaphylaxis or serious hypersensitivity reactions
  - Thrombosis / embolic events
  - Pancreatitis
  - Hepatotoxicity / severe liver injury
  - Hemorrhage
  - Glucose intolerance / hyperglycemia requiring insulin
Contraindications:
- History of serious hypersensitivity to pegaspargase or any component
- Prior serious thrombosis with L-asparaginase therapy
- Prior history of pancreatitis associated with L-asparaginase
- Prior serious hemorrhagic events with L-asparaginase therapy
- Severe hepatic impairment (e.g. bilirubin >3× ULN, transaminases > 10× ULN)
Precautions:
- Monitor for hypersensitivity and infusion reactions; observe for at least 1 hour post-administration
- Monitor liver function tests, bilirubin, transaminases
- Monitor coagulation parameters (PT, aPTT, fibrinogen) and for signs of bleeding or thrombosis
- Monitor pancreatic enzymes / signs of pancreatitis
- Monitor serum glucose (risk of hyperglycemia)
- In patients with previous hypersensitivity, consider switching to alternative asparaginase forms
- Pregnancy / lactation: use with caution; animal studies show teratogenic risk; discontinue breastfeeding during treatment

Pegaspargase Interactions

Because pegaspargase may reduce serum proteins, it can increase toxicity of protein-bound drugs
It can interfere with other agents requiring protein synthesis / cell division (e.g. methotrexate, cytarabine)
Interaction with vincristine: effects may be potentiated or altered; caution advised

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.