pegaspargase (Rx)

Brand and Other Names:Oncaspar, PEG L Asparaginase
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Dosing & Uses

AdultPediatric

Dosage Forms & 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

Dosage Forms & 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

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Interactions

Interaction Checker

and pegaspargase

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Adverse 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
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            Warnings

            Contraindications

            Hypersensitivity

            History of (with prior L-asparaginase treatment): pancreatitis, including pancreatitis related to prior L-asparaginase therapy; 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, hypersensitivity reactions is higher in patients with known hypersensitivity to E. coli derived L-asparaginase formulations; other hypersensitivity reactions can include angioedema, lip swelling, eye swelling, erythema, blood pressure decreased, bronchospasm, dyspnea, pruritus, and rash 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; evaluate bilirubin and transaminases at least weekly during cycles of treatment that include drug through at least 6 weeks after last dose; in event of serious liver toxicity, discontinue treatment with therapy and provide supportive care

            Discontinue if pancreatitis occurs; evaluate patients with abdominal pain for pancreatitis; hemorrhagic or necrotizing pancreatitis with fatal outcomes have been reported; assess serum amylase and/or lipase levels to confirm early signs of pancreatic inflammation; discontinue therapy in patients where pancreatitis suspected; if pancreatitis confirmed, do not resume therapy

            Serious thrombotic events, including sagittal sinus thrombosis reported; discontinue if this occurs

            Evaluate patients with signs and symptoms of hemorrhage with coagulation parameters including PT, PTT, fibrinogen; consider appropriate replacement therapy in patients with severe or symptomatic coagulopathy

            Increased prothrombin time, increased PTT and hypofibrinogenemia may occur; monitor for coagulopathy

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            Pregnancy & Lactation

            Pregnancy

            There are no available data on the use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage; published literature studies in pregnant animals suggest asparagine depletion may cause harm to animal offspring; advise patients of potential risk to a fetus

            Patients with reproductive potential

            • Based on studies in pregnant animals, drug can cause fetal harm when administered to a pregnant woman
            • Conduct pregnancy testing in females of reproductive potential prior to starting treatment
            • Advise females of reproductive potential to avoid becoming pregnant while receiving therapy
            • Females should use effective contraceptive methods, including a barrier method, during treatment and for at least 3 months after last dose; since there is a potential for an indirect interaction between therapy and oral contraceptives, concomitant use of drug and oral contraceptives is not recommended; another, non-oral contraceptive method should be used in women of childbearing potential

            Lactation

            There are no data on presence of drug in human milk, effects on breastfed child, or on milk production; because many drugs are excreted in human milk and because of potential for adverse reactions in a breastfed child, advise lactating women not to breastfeed while receiving drug and for 3 months after last dose

            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.

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            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)

            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

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.