Drug Action
Pegaspargase breaks down the amino acid L-asparagine, thereby interfering with the growth of malignant cells, which are unable to synthesise L- asparagine.
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Drug reference
Pegaspargase breaks down the amino acid L-asparagine, thereby interfering with the growth of malignant cells, which are unable to synthesise L- asparagine.
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Acute lymphoblastic leukaemia (in combination with other antineoplastic drugs) (specialist use only) ▶BY INTRAMUSCULAR INJECTION, OR BY INTRAVENOUS INFUSION ▶Adult 18–21 years: 2500 units/m2 every 14 days ▶Adult 22 years and over: 2000 units/m2 every 14 days
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History of pancreatitis. history of serious haemorrhagic event with previous L-asparaginase therapy. history of serious thrombosis with previous L- asparaginase therapy
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Concomitant use of other hepatotoxic drugs (particularly in pre-existing hepatic impairment)—monitor hepatic function. diabetes (may raise blood glucose). hypersensitivity reactions. marked decrease of leukocyte count at start of treatment is possible—may be associated with significant rise in serum uric acid and development of uric acid nephropathy CAUTIONS, FURTHER INFORMATION ▶Hypersensitivity reactions Serious hypersensitivity reactions, including life-threatening anaphylaxis, can occur— pegaspargase should only be administered when appropriately trained staff and resuscitation facilities are immediately available; manufacturer advises patients should be closely monitored for signs of hypersensitivity during treatment and for an hour after administration. In the event of a hypersensitivity reaction, treatment should be stopped immediately and appropriate management initiated.
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NICE decisions ▶Pegaspargase for treating acute lymphoblastic leukaemia (September 2016) NICE TA408 Pegaspargase, as part of antineoplastic combination therapy, is recommended as an option for treating acute lymphoblastic leukaemia only in patients with untreated newly diagnosed disease. Patients whose treatment was started within the NHS before this guidance was published may continue treatment until they and their clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta408 Scottish Medicines Consortium (SMC) decisions The Scottish Medicines Consortium has advised (November 2016) that pegaspargase (Oncaspar ®) is accepted for use within NHS Scotland as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia.
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→Appendix 1: pegaspargase
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▶Common or very common Abdominal pain. anaemia. appetite decreased. ascites. bone marrow disorders. coagulation disorders. diarrhoea. dyslipidaemia. embolism and thrombosis. febrile neutropenia. hepatic disorders. hyperglycaemia. hypersensitivity. hypoalbuminaemia. hypokalaemia. hypoxia. increased risk of infection. nausea. pain in extremity. pancreatitis (discontinue if suspected and do not restart if confirmed). peripheral neuropathy. seizure. sepsis. skin reactions. stomatitis. syncope. vomiting. weight decreased ▶Rare or very rare Haemorrhage. necrotising pancreatitis. posterior reversible encephalopathy syndrome (PRES) ▶Frequency not known Acute kidney injury. confusion. diabetic ketoacidosis. drowsiness. fever. hyperammonaemia (monitor if symptoms present). hypoglycaemia. pancreatic pseudocyst. stroke. toxic epidermal necrolysis. tremor SIDE-EFFECTS, FURTHER INFORMATION There have been rare reports of cholestasis, icterus, hepatic cell necrosis and hepatic failure with fatal outcome in patients receiving pegaspargase.
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Manufacturer advises effective contraception in men and women of child- bearing potential during treatment and for at least 6 months after discontinuing treatment; pegaspargase may reduce effectiveness of oral contraceptives— additional precautions (e.g. barrier method) are required, see also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid unless essential. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid—no information available.
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Manufacturer advises avoid in severe impairment.
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▶Manufacturer advises trough serum asparaginase activity levels may be measured before the next administration of pegaspargase; consider switching to a different asparaginase preparation if target levels not reached—seek expert advice. ▶Manufacturer advises monitor plasma and urine glucose levels during treatment; monitor coagulation profile at baseline and periodically during and after treatment (particularly with concomitant use of other drugs that inhibit coagulation); monitor serum amylase.
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Manufacturer advises for intramuscular injection, volumes over 3 mL must be divided between more than one site. l HANDLING AND STORAGE Manufacturer advises store in a refrigerator between 2–8°C.
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There can be variation in the licensing of different medicines containing the same drug. Solution for injection ▶Oncaspar (Servier Laboratories Ltd) A Pegaspargase 750 unit per 1 ml Oncaspar 3,750units/5ml solution for injection vials | 1 vial P £1,296.19 Powder for solution for injection ▶Oncaspar (Servier Laboratories Ltd) A Pegaspargase 3750 unit Oncaspar 3,750unit powder for solution for injection vials | 1 vial P £1,296.19 (Hospital only)
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Pancreatitis Manufacturer advises patients and carers should be told how to recognise signs and symptoms of pancreatitis and advised to seek medical attention if symptoms such as persistent, severe abdominal pain develop. Driving and skilled tasks Manufacturer advises patients and carers should be counselled on the effects on driving and performance of skilled tasks—increased risk of confusion and somnolence.
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2500 units/m2 every 14 days
First-line fragment. Read the complete Indications and Dose section above.
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2000 units/m2 every 14 days
First-line fragment. Read the complete Indications and Dose section above.
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