PEG L Asparaginase Injection

Warnings:

• Contraindications
• Hypersensitivity
• History of (with prior L-asparaginase treatment): pancreatitis; hemorrhagic events; serious thrombosis

Cautions:

• No more than 2 mL should be administered at any one injection site
• Anaphylaxis or serious allergic reactions may occur, monitor patient for 1 hr after administration; discontinue with serious allergic reactions
• Glucose intolerance reported (irreversible in some cases); monitor serum glucose
• Hepatotoxicity and abnormal liver function, including elevations of AST (SGOT), ALT (SGPT), alkaline phosphatase, bilirubin (direct and indirect), and depression of serum albumin, and plasma fibrinogen may occur; monitor

• Discontinue if pancreatitis occurs; evaluate patients with abdominal pain for pancreatitis
• Serious thrombotic events, including sagittal sinus thrombosis reported; discontinue if this occurs
• Increased prothrombin time, increased PTT and hypofibrinogenemia may occur; monitor for coagulopathy

Pregnancy & Lactation

• Pregnancy Category: C
• Lactation: not known if excreted in breast milk

Pregnancy Categories

• A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
• B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
• C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
• D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
• X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

Pharmacology

• Mechanism of Action
• Modified version of L-asparaginase depletes asparagine, the aminoacid required for protein synthesis, and in turn kills leukemic cells

Pharmacokinetics

• Half-Life: 5-5.6 days
• Onset: Asparagine depleted within 4 days (IM)
• Duration: 21 days (IM); 2-4 weeks (IV in asparaginase naive adults)
• Vd: 1.5 L/m² (IM in children); 2.4 L/m² (IV in adults)
• Metabolism: Systemically

• Peak plasma time: 3-4 days (IM)
• Excretion: Urine (trace amounts)

Storage

• Refrigerate
• Do not use if cloudy or if precipitate is present
• Do not freeze