Aiyang Pegaspargase Injection

1. Indications and Usage
Acute Lymphoblastic Leukemia (ALL): Indicated for the treatment of acute lymphoblastic leukemia in children and adults, typically as a component of multi-agent combination chemotherapy regimens.
2. Dosage and Administration
Route of Administration: Intramuscular (IM) or Intravenous (IV) administration.
Recommended Dosage: 2500 IU/m² administered every 14 days.
Administration Details:
IM: The volume injected at a single site should not exceed 2 mL. If a larger volume is required, multiple injection sites must be used.
IV: Administer slowly over 10 to 60 minutes. Do not administer as an IV push or bolus.
Preparation: Inspect visually for particulate matter or discoloration prior to administration. Do not use if frozen, shaken, or kept at room temperature for more than 48 hours.
3. Mechanism of Action
Asparagine Depletion: Pegaspargase is a modified form of L-asparaginase.
Anti-Tumor Effect: It depletes circulating asparagine, an essential amino acid for the survival and proliferation of lymphoblasts, which lack the enzyme asparagine synthetase to synthesize it endogenously.
4. Safety and Warnings
Hypersensitivity: Severe anaphylaxis, including angioedema and bronchospasm, may occur. The drug must be administered with appropriate resuscitation equipment immediately available.
Hemorrhage and Thrombosis: Significant changes in coagulation parameters (e.g., decreased fibrinogen, prolonged PT/PTT) can lead to severe bleeding or thrombotic events (including cerebral venous sinus thrombosis).
Pancreatitis: Severe, potentially fatal acute pancreatitis may occur. Patients should be monitored for abdominal pain, elevated amylase, and lipase.
Hepatotoxicity: Transaminase elevations, hyperbilirubinemia, and hypoproteinemia may occur.
Hyperglycemia: Impairment of glucose tolerance, sometimes requiring insulin, may occur.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Hypersensitivity reactions, elevated transaminases, hyperbilirubinemia, coagulation abnormalities, hyperglycemia, central nervous system thrombosis, and pancreatitis.
Clinical Research Highlights: Clinical trials have demonstrated that pegaspargase significantly improves disease-free survival and overall survival when included in induction and consolidation regimens for ALL.
6. Drug Interactions
Live Vaccines: Avoid live or live-attenuated vaccines during treatment due to immunosuppression.
Anticoagulants/Thrombolytics: Concomitant use may increase the risk of hemorrhage or thrombosis due to altered coagulation profiles.
L-asparaginase: Concomitant use with other forms of L-asparaginase may lead to cross-hypersensitivity or accelerated clearance.
7. Pharmaceutical Information
Chemical Composition: Active ingredient: Pegaspargase (PEGylated bacterial L-asparaginase).
Appearance: Clear to slightly opalescent, colorless to pale yellow liquid.
Packaging: Supplied in single-use vials (e.g., 3750 IU/5 mL).
Storage: Store in a refrigerator at 2°C to 8°C; do not freeze or shake. Protect from light.