This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo

Pegaspargase parenteral


Parenteral formulations of pegaspargase

Drugs List

  • ONCASPAR (E.coli derived asparaginase) 3750unit powder for solution for injection vial
  • pegaspargase (e.coli derived asparaginase) 3750unit powder for solution for injection vial
  • Therapeutic Indications


    Leukaemia - acute lymphoblastic

    Combination treatment of acute lymphoblastic leukaemia (ALL).


    Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.


    Patients over 21 years
    The recommended dose is 2000 units/metre squared body surface area every 14 days.


    Patients 21 years or younger with body surface area (BSA) less than 0.6 metres squared
    The recommended dose is 82.5 units/kg body weight every 14 days.

    Patients 21 years or younger with body surface area (BSA) greater than 0.6 metres squared
    The recommended dose is 2500 units/metre squared BSA every 14 days.


    For intramuscular injection or intravenous infusion.

    When given as an intramuscular injection volume injected into one site should not exceed 2 ml in children and 3 ml in adults. Higher volumes should be split over several injection sites.

    Intravenous infusion should be given over a period of 1 to 2 hours.


    History of significant haemorrhage
    Hepatic enzymes above 10 times the upper limit of normal
    History of pancreatitis
    History of thrombosis
    Serum bilirubin above 3 times upper limit of normal

    Precautions and Warnings

    Patients over 65 years
    Hepatic impairment

    Live virus vaccine should not be given for 3 months after treatment
    Advise ability to drive/operate machinery may be affected by side effects
    Advise patient to avoid vincristine for 12 hours before dose
    Treatment to be initiated and supervised by a specialist
    Consult local policy on the safe use of anti-cancer drugs
    Record name and batch number of administered product
    Resuscitation facilities must be immediately available
    Staff: Not to be handled by pregnant staff
    When intramuscular route used divide large doses among various sites
    Monitor ammonia levels if hyperammonaemia suspected
    Monitor bilirubin levels at baseline and prior to each dose
    Monitor blood counts regularly
    Monitor blood glucose
    Monitor coagulation values
    Monitor for signs of bone marrow depression
    Monitor hepatic function
    Monitor serum amylase and lipase regularly
    Advise patient to report headaches, seizures, confusion, visual disturbance
    Advise patients to report symptoms of acute pancreatitis immediately
    Monitor for hypersensitivity reactions for 1 hour after administration
    Neutralising antibodies may develop that decrease clinical efficacy
    Potential for increased risk of bleeding
    Risk of developing opportunistic infections
    Use of live vaccines may cause severe reaction
    Discontinue if pancreatitis is suspected
    Discontinue if patient develops thrombus
    Discontinue if posterior reversible encephalopathy syndrome (PRES) develops
    Discontinue if serious allergic or anaphylactic reaction occurs
    Do not restart treatment following confirmation of pancreatitis
    Advise patients to avoid aspirin and NSAID use
    Female: Non-hormonal contraception advised until 6 months after treatment
    Female: Oral contraception may not be adequate during treatment
    Male: Contraception required during and for 6 months after treatment

    Asparaginase activity level should be monitored prior to each dose. Low asparaginase activity levels are often due to anti-asparaginase antibodies. In such cases a switch to a different asparaginase should be considered.

    There is a possible risk of hepatotoxicity in patients with Philadelphia chromosome-positive ALL when treated in combination with imatinib, therefore use with caution in these patients.

    Posterior Reversible Encephalopathy Syndrome (PRES) also known as Reversible Posterior Leucoencephalopathy Syndrome (RPLS)
    Posterior reversible encephalopathy syndrome (PRES) has been reported in some patients treated with this agent. If patients present with symptoms indicating PRES such as headache, altered mental state, seizures and visual disturbances, an MRI should be performed. If PRES is diagnosed, treatment should be discontinued and adequate blood pressure and seizure control administration is advisable. The safety of reinstating treatment in patients previously experiencing PRES is unknown.

    Pregnancy and Lactation


    Pegaspargase is contraindicated during pregnancy.

    The manufacturer recommends that pegaspargase should not be used during pregnancy unless the clinical condition of the woman requires treatment with pegaspargase. No animal studies with pegaspargase have been performed at time of writing. However studies with L-asparaginase have shown teratogenicity in animals with doses within the therapeutic range.

    The effect of concurrent therapies must also be considered.


    Pegaspargase is contraindicated during breastfeeding.

    The manufacturer recommends that breastfeeding should be discontinued during pegaspargase treatment and should not be restarted until pegaspargase discontinuation. It is not known whether this agent or its metabolites are excreted in human breast milk, however there is potential for serious toxicity in the nursing infant.

    The effect of concurrent therapies must also be considered.

    Side Effects

    Abdominal cramps
    Abdominal pain
    Acute renal failure
    Alanine aminotransferase increased
    Anaphylactic reaction
    Aspartate aminotransferase increased
    Blood lipid changes
    Blood urea increased
    Cerebrovascular accident
    Coagulation disorders
    Decreased appetite
    Decreased serum albumin
    Development of neutralising antibodies
    Diabetic ketoacidosis
    Elevated amylase levels
    Febrile neutropenia
    Fine tremor (usually hands)
    Gamma glutamyl transferase (GGT) increased
    Haemorrhagic pancreatitis
    Hepatic disorders (fatty changes)
    Hepatic failure
    Hepatocellular necrosis
    Hypersensitivity reactions
    Increase in plasma cholesterol
    Increased partial thromboplastin time
    Necrotising pancreatitis
    Painful extremities
    Peripheral motor neuropathy
    Prothrombin time increased
    Reduced platelet count
    Reduction of fibrinogen
    Reversible posterior leucoencephalopathy syndrome (RPLS)
    Serum bilirubin increased
    Superior sagittal sinus thrombosis
    Toxic epidermal necrolysis
    Weight loss


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: August 2019

    Reference Sources

    Summary of Product Characteristics. Oncaspar 750 U/ml solution for injection/infusion. Servier Laboratories Ltd. April 2019
    Summary of Product Characteristics. Oncaspar 750 U/ml powder for solution for injection/infusion. Servier Laboratories Ltd. April 2019

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

    FDB Logo

    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.