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L-asparaginase Pregnancy: Section 4.6: no adequate data from use of crisantaspase in pregnant women; based on effects on embryonal/foetal development in pre-clinical studies, Erwinase should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Women of childbearing potential should use effective contraception (not oral contraceptives) and avoid becoming pregnant; men should use effective contraception and not father a child during treatment, with a wait of three months after completion recommended as a precaution. Not known whether it is excreted in human breast milk; Erwinase should be discontinued during breastfeeding. No human fertility data; decreased sperm count was observed in male rats.

Crisantaspase (Specialist drug)

Brand names: Erwinase

Crisantaspase is a bacterial (Erwinia-derived) asparaginase enzyme used as a component of combination chemotherapy for acute lymphoblastic leukaemia, particularly where hypersensitivity to E. coli asparaginase has occurred.

Adult dose

Dose: Component of a chemotherapeutic regimen for acute lymphoblastic leukaemia (ALL) in patients who have developed hypersensitivity to E. coli-derived asparaginase: 20,000 or 25,000 IU/m2 body surface area, three times a week (e.g. Monday/Wednesday/Friday). Therapy should be adjusted according to local treatment protocols.
Route: Intravenous infusion or intramuscular injection (both routes covered by this SPC)
Frequency: Three times a week (e.g. Monday/Wednesday/Friday)
SPECIALIST USE: for use within a chemotherapy regimen under local treatment protocols. Strength: Erwinase 10,000 IU per vial of powder (crisantaspase, L-asparaginase from Erwinia chrysanthemi) (SPC section 2). Indication (section 4.1): 'a component of a chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukaemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase'; 'indicated in infants from the age of 4 months and in adults'. The SPC states ONE regimen for patients in this indication and gives no separate paediatric regimen, so no paediatric block is written. METHOD (section 4.2): for IV infusion the reconstituted solution should be further diluted in 100 mL of normal saline and administered over 1 to 2 hours; for IM injection the volume of reconstituted solution at a single injection site should not exceed 2 mL, with multiple injection sites used if this volume is exceeded; for reconstitution see section 6.6 (not retrieved). The SPC prints no maximum dose, and section 4.2 is not truncated. Record the tradename and batch number of the administered product in the patient file (section 4.4). Some sections of the product information we used were incomplete — check the full SPC.

Dose adjustments

Renal

Section 4.2 states no renal dose adjustment. The section 4.4 'Renal Impairment' paragraph is truncated at the source-fetch limit and was not retrieved.

Hepatic

Section 4.2 states no hepatic dose adjustment. Section 4.4: L-asparaginase can cause or worsen hepatic injury; in case of severe hepatic adverse reactions, discontinuation should be considered until complete or near-complete (CTCAE Grade 1) recovery, and treatment re-instituted only under very close monitoring.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via MHRA Products — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • History of severe hypersensitivity to the active substance or to any of the excipients (section 4.3)
  • Current or past severe pancreatitis associated with L-asparaginase therapy (section 4.3)
  • Current pancreatitis not associated with L-asparaginase therapy (section 4.3)

Side effects

  • The two most frequent adverse reactions (section 4.8): hypersensitivity (urticaria, fever, arthralgia, angioedema, bronchospasm, hypotension or even anaphylactic shock) and coagulation abnormalities (e.g. thromboses of peripheral, pulmonary or central nervous system vessels, potentially fatal)
  • Hypersensitivity reactions including anaphylaxis, which can occur on first or subsequent administrations; severe reactions are common; local reactions at or near the IM/IV site (section 4.4)
  • Pancreatitis, which can be severe and fatal; chronic pancreatitis and persistent pancreatic insufficiency reported (section 4.4)
  • Glucose intolerance and potentially severe hyperglycaemia; ketoacidosis in some patients (section 4.4)
  • Decreased synthesis of coagulant, anticoagulant and fibrinolytic proteins with serious thromboembolic and bleeding events (section 4.4)
  • Hepatic effects: raised transaminases and bilirubin, hepatic steatosis, hepatic failure, hypoalbuminaemia (section 4.4)
  • CNS toxicity including encephalopathy, seizures, CNS depression and posterior reversible encephalopathy syndrome (PRES) (section 4.4)
  • Table 1 terms in section 4.8 include infections/sepsis, leukopenia (including neutropenia), thrombocytopenia, anaemia, febrile neutropenia, hyperlipidaemia, increased amylase and/or lipase, weight loss, hyperglycaemia, diabetic ketoacidosis and hyperammonaemia
  • SCOPE NOTE: sections 4.4 and 4.8 are truncated at the source-fetch limit, so this list is partial

Interactions

  • Must not be mixed with any other medicinal products prior to administration (section 4.5)
  • Methotrexate, cytarabine - L-asparaginase may diminish or abolish their effect on malignant cells while plasma asparagine is suppressed; do not use methotrexate or cytarabine with, or following, L-asparaginase while asparagine levels are below normal; giving L-asparaginase after methotrexate or cytarabine results in a synergistic effect (section 4.5)
  • Prednisone - may increase the risk of a change in clotting parameters (e.g. decrease in fibrinogen and ATIII) (section 4.5)
  • Vincristine - given concurrently with or immediately before L-asparaginase may be associated with increased toxicity and increased risk of anaphylaxis (section 4.5)
  • Medicinal products affecting liver function may increase the risk of a change in liver parameters (section 4.5)
  • Oral contraceptives are not considered sufficiently safe because an indirect interaction cannot be ruled out; use another method (sections 4.5, 4.6)

Monitoring

  • Routine clotting screening before treatment initiation and monitored during treatment (section 4.4)
  • Hepatic function tests regularly during therapy (section 4.4)
  • Signs and symptoms of pancreatic toxicity, including late-occurring signs; serum amylase and lipase if pancreatitis is suspected (section 4.4)
  • Hyperglycaemia and its complications (section 4.4)
  • Consider serum ammonia in patients with CNS toxicity (section 4.4)
  • Facilities for management of an anaphylactic reaction should be available during administration; careful observation on re-exposure after any interval (section 4.4)

Clinical monograph

How it works

It depletes circulating asparagine by hydrolysing it to aspartic acid and ammonia; leukaemic cells cannot synthesise asparagine and are selectively starved of this amino acid, impairing protein synthesis and survival.

Prescribing in practice

  • Hypersensitivity and anaphylaxis are major risks, so administration requires resuscitation facilities and close observation.
  • Other important toxicities include coagulopathy (thrombosis or bleeding), pancreatitis and hyperglycaemia.
  • A specialist agent given only within haemato-oncology protocols under expert supervision per the SPC.

Monitoring

Monitor for hypersensitivity reactions, coagulation parameters, blood glucose and for clinical signs of pancreatitis during therapy.

Counselling the patient

  • Report any rash, breathlessness or swelling during or after the injection immediately.
  • Report severe abdominal pain, which may indicate pancreatitis.
  • Increased thirst or other symptoms of high blood sugar should be reported.

Evidence & guidelines

Its role is supported by the SPC and acute lymphoblastic leukaemia treatment protocols, where it serves as an alternative asparaginase preparation.

Reference: 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).

Related

Curated clinical cross-links plus same-class fallbacks.

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