- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Parenteral formulations of pegaspargase
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
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.
Acute renal failure
Alanine aminotransferase increased
Aspartate aminotransferase increased
Blood lipid changes
Blood urea increased
Decreased serum albumin
Development of neutralising antibodies
Elevated amylase levels
Fine tremor (usually hands)
Gamma glutamyl transferase (GGT) increased
Hepatic disorders (fatty changes)
Increase in plasma cholesterol
Increased partial thromboplastin time
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
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: August 2019
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
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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.