Enzyme Cytotoxic — Asparagine Depletion Agent (Specialist Oncology Drug) Pregnancy: Should not be used during pregnancy unless the woman's clinical condition requires treatment; embryotoxic and teratogenic in animal studies. Women of childbearing potential must use effective non-oral contraception during treatment and for 7 months afterwards; men for 4 months. Discontinue breast-feeding during treatment.

Asparaginase

Brand names: Spectrila (Erwinia crisantaspase — Erwinase), Oncaspar (pegaspargase)

Asparaginase is an enzyme used as a cytotoxic agent in the treatment of acute lymphoblastic leukaemia, as part of combination chemotherapy regimens.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 5,000 units/m² body surface area (U/m²) by intravenous infusion, every third day

Route: intravenous infusion only (over 0.5 to 2 hours); must not be given as a bolus dose

Frequency: every third day

Specialist use — should be prescribed and administered by physicians/personnel experienced in antineoplastic products, in a hospital setting with resuscitation equipment available. Product characterised: Spectrila (recombinant E. coli L-asparaginase). Usually employed as part of combination chemotherapy protocols. Dose applies to adults and children older than 1 year: 5,000 U/m² BSA given every third day. Treatment may be monitored by trough serum asparaginase activity measured three days after administration; if target levels are not reached, a switch to a different asparaginase preparation could be considered. May be diluted in a final volume of 50-250 ml sodium chloride 0.9%. Data on efficacy/safety in adults and in post-induction phases are limited.

Paediatric dose

Route: intravenous infusion

Frequency: every third day

Dosing is per body surface area (units/m²), not per kg. Children older than 1 year: 5,000 U/m² BSA every third day (same as adults). Infants 0-12 months (based on limited data): age less than 6 months, 6,700 U/m² BSA; age 6-12 months, 7,500 U/m² BSA. Unit is U/m² (BSA-based) — not mg or mg/kg.

Dose adjustments

Renal

No dose adjustment is necessary in patients with renal impairment.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance, any native (non-pegylated) E. coli-asparaginase preparation, or to any of the excipients
Pancreatitis
Severe hepatic impairment (bilirubin >3× ULN; transaminases >10× ULN)
Pre-existing known coagulopathy (e.g. haemophilia)
History of pancreatitis, serious haemorrhage or serious thrombosis with prior asparaginase therapy

Side effects

Hypersensitivity reactions (flushing, rash, hypotension, oedema/angioedema, urticaria, dyspnoea; rarely anaphylactic shock)
Hyperglycaemia
Hypoalbuminaemia
Nausea, vomiting, diarrhoea, abdominal pain
Acute pancreatitis and hepatotoxicity
Coagulation disorders (thrombosis, bleeding)

Interactions

Usually used in combination chemotherapy protocols with other antineoplastic agents (see section 4.5)

Clinical monograph

How it works

It depletes circulating asparagine by hydrolysing it; leukaemic cells unable to synthesise asparagine are selectively deprived of it, impairing protein synthesis and survival.

Prescribing in practice

Hypersensitivity reactions, including anaphylaxis, are an important risk, so administer under supervision with resuscitation facilities and observe after dosing.
Pancreatitis, hepatotoxicity, coagulopathy with both thrombosis and bleeding, and hyperglycaemia can occur.
Administered parenterally by clinicians experienced in chemotherapy; a pegylated formulation is commonly used.

Monitoring

Monitor for hypersensitivity, amylase/lipase for pancreatitis, liver function, coagulation parameters, and blood glucose.

Counselling the patient

Report rash, swelling, or breathing difficulty during or after the injection.
Report severe abdominal pain, which may indicate pancreatitis.
Treatment is given as part of a leukaemia regimen in a specialist setting.

Evidence & guidelines

Asparaginase is a longstanding component of acute lymphoblastic leukaemia regimens; consult the SPC and current prescribing references for formulation-specific detail.

Reference: NICE NG214 (Acute lymphoblastic leukaemia); UKALL treatment protocols; ESMO ALL Guidelines; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways