Dosing and uses of Oncaspar, PEG L Asparaginase (pegaspargase)
Adult dosage forms and strengths
powder for injection
- 750 units (5 mL)
Acute Lymphoblastic Leukemia
For use in patients with hypersensitivity to native forms of L-asparaginase
First line agent as part of multiagent chemotherapeutic regimen
2500 international units/m² IM (preferred) or IV q14Days
Monitor CBC, serum amylase
Pediatric dosage forms and strengths
powder for injection
- 750 units
Acute Lymphoblastic Leukemia
2500 units/m² IM (preferred) or IV q14Days
Off-label Dosing
- BSA ≤ 0.6 m²: 82.5 units/kg IM or IV q14Days as part of multiagent chemotherapeutic regimen
- BSA >0.6 m²: 2500 units/m² IM (preferred) or IV q14Days as part of multiagent chemotherapeutic regimen
Monitor
CBC, serum amylase
Oncaspar, PEG L Asparaginase (pegaspargase) adverse (side) effects
1-10%
>5%
- Edema
- Fever, malaise
- Nausea, vomiting
- Coagulopathy
- Rash
- ALT increased
- Dyspnea
- Erythema
- Urticaria
- Swelling
- Chills
1-5%
- Anaphylaxis
- Hypotension
- Peripheral edema
- Tachycardia
- Thrombosis
- CNS toxicity
- Chills
- Headache
- Pain
- Seizure
- Erythema, rash, urticaria
- Hyperglycemia, hyperuricemia, hypoglycemia, hypoproteinemia, hyperlipidemia
- Bleeding tendency
- LFT abnormalities, AST increased, jaundice, hyperbilirubinemia
- Dyspnea
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 and 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.
NA: Information not available.
Pharmacology of Oncaspar, PEG L Asparaginase (pegaspargase)
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)
IV/IM Administration
No need for test dose
IM: must only be given as a deep intramuscular injection into a large muscle; limit the volume of a single injection site to 2 mL; if the volume to be administered is >2 mL, use multiple injection sites
IV given as a 1- to 2- hr infusion; do not give IV push
Administration
- Have parenteral epinephrine, diphenhydramine, and hydrocortisone available at the bedside
- Have a freely running IV in place
- Have a physician readily accessible
- Monitor the patients closely for 30-60 min
- Do not filter solution
- Have available appropriate agents for maintenance of an adequate airway and treatment of a hypersensitivity reaction (antihistamine, epinephrine, oxygen, IV corticosteroids)
- Be prepared to treat anaphylaxis at each administration
- Administer through an infusion that is already running
IV/IM Preparation
Reconstitution: Avoid excessive agitation; do not shake
Standard IM dilution: Do not exceed 2 mL volume per injection site
Standard IV dilution: Dose/100 mL NS or D5W
Storage
Refrigerate
Do not use if cloudy or if precipitate is present
Do not freeze
