Why is rasburicase dangerous in G6PD deficiency?

It is contraindicated in G6PD deficiency because breaking down uric acid generates hydrogen peroxide, which can trigger severe haemolytic anaemia and methaemoglobinaemia. At-risk patients should be screened before treatment.

How is rasburicase different from allopurinol?

Allopurinol only blocks new uric acid formation, whereas rasburicase enzymatically destroys existing uric acid, lowering levels much faster; trials show superior uric acid control.

Is rasburicase FDA and EMA approved?

Yes. It was approved in the EU (Fasturtec) in 2001 and by the US FDA (Elitek) in 2002 for hyperuricaemia in the setting of malignancy and its treatment.

Do blood tests need special handling during rasburicase treatment?

Yes. Because rasburicase continues to break down uric acid in a collected sample at room temperature, uric acid specimens must be kept on ice and processed promptly to avoid falsely low results.

EMA-approvedaka Elitek

Rasburicase — Complete Research Guide (2026)

Last updated 2026-06-30

TL;DR

Rasburicase (also known as Elitek) is a peptide catalogued under Enzymes (Recombinant urate oxidase). Neutral reference entry; EU status: EU-approved prescription medicine.

What is Rasburicase?

Rasburicase (brand names Elitek in the US and Fasturtec in the EU) is a recombinant urate oxidase (uricase) used to manage and prevent severe hyperuricaemia associated with tumour lysis syndrome, chiefly in patients receiving chemotherapy for leukaemia, lymphoma, and other high-tumour-burden malignancies. It was approved by the EMA (Fasturtec) in 2001 and the US FDA (Elitek) in 2002.

It is supported by a high level of human clinical evidence, including randomized trials in children and adults.

It is a hospital-administered prescription biologic, not a supplement.

How does Rasburicase work?

Rasburicase is a recombinant form of urate oxidase, an enzyme absent in humans, that catalyses the oxidation of uric acid into allantoin, which is far more water-soluble and readily excreted.

This rapidly lowers existing plasma uric acid rather than merely blocking new production, distinguishing it from allopurinol.

What does the research say about Rasburicase?

In children at high risk of tumour lysis syndrome, a randomized trial showed rasburicase controlled plasma uric acid faster and more effectively than allopurinol. ^[1]
In a large adult phase III trial, rasburicase (alone or followed by allopurinol) achieved superior uric acid control compared with allopurinol alone. ^[4]
Compassionate-use and prophylaxis/treatment studies confirmed rapid, reliable uric acid reduction across pediatric and adult patients with leukaemia or lymphoma. ^[2]

Clinical research & studies

The references below are the primary sources cited throughout this guide. Each links directly to PubMed or the regulator. Where evidence is preclinical (animal or in-vitro), that is stated rather than implied.

[1] A randomized comparison between rasburicase and allopurinol in children with lymphoma or leukemia at high risk for tumor lysis — Goldman SC et al., Blood 2001. (Randomized controlled trial (pediatric))
[2] Recombinant urate oxidase for the prophylaxis or treatment of hyperuricemia in patients With leukemia or lymphoma — Pui CH et al., Journal of Clinical Oncology 2001. (Prospective clinical study)
[3] Recombinant urate oxidase (rasburicase) in the prevention and treatment of malignancy-associated hyperuricemia in pediatric and adult patients: results of a compassionate-use trial — Pui CH et al., Leukemia 2001. (Compassionate-use clinical trial)
[4] Control of plasma uric acid in adults at risk for tumor Lysis syndrome: efficacy and safety of rasburicase alone and rasburicase followed by allopurinol compared with allopurinol alone - results of a multicenter phase III study — Cortes J et al., Journal of Clinical Oncology 2010. (Randomized, multicenter phase III trial (adults))
[5] Recommendations for the evaluation of risk and prophylaxis of tumour lysis syndrome (TLS) in adults and children with malignant diseases: an expert TLS panel consensus — Cairo MS et al., British Journal of Haematology 2010. (Expert consensus guideline)
[6] Rasburicase-induced hemolytic anemia and methemoglobinemia: a systematic review of current reports — Hammami MB et al., Annals of Hematology 2024. (Systematic review)

Dosing context

This is not medical advice or a usage recommendation. Dosing figures are reported research context only, cited from the published literature.

For context only and not as medical advice, rasburicase is given as an intravenous infusion (commonly around 0.2 mg/kg once daily) over a short course of up to about five days, timed around chemotherapy.

Actual dose, duration, and G6PD screening are determined by the treating oncology team.

Side effects & safety profile

Rasburicase is CONTRAINDICATED in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency, because the hydrogen peroxide generated when it breaks down uric acid can cause severe haemolytic anaemia and methaemoglobinaemia; at-risk patients (including those of African, Mediterranean, or Southeast Asian ancestry) should be screened for G6PD deficiency before use.

Hypersensitivity and infusion/anaphylactic reactions can occur, and anti-drug antibodies may develop.

Because rasburicase degrades uric acid in vitro at room temperature, blood samples for uric acid must be collected on ice to avoid falsely low readings.

Stacking & combinations

It may be used alone or sequenced with allopurinol for ongoing control, but it should never be combined with agents or used in patients where G6PD-related haemolysis risk is unaddressed.

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Frequently asked questions

It is an approved recombinant urate oxidase (Elitek/Fasturtec) used to prevent and treat severe hyperuricaemia in tumour lysis syndrome, typically during chemotherapy for leukaemia, lymphoma, and other high-burden cancers.

References

[1] A randomized comparison between rasburicase and allopurinol in children with lymphoma or leukemia at high risk for tumor lysis — Goldman SC et al., Blood 2001. PMID: 11342423. View sourceStudy: Randomized controlled trial (pediatric)Rasburicase lowered plasma uric acid faster and to a greater degree than allopurinol in children at high risk of tumour lysis.
[2] Recombinant urate oxidase for the prophylaxis or treatment of hyperuricemia in patients With leukemia or lymphoma — Pui CH et al., Journal of Clinical Oncology 2001. PMID: 11157020. View sourceStudy: Prospective clinical studyRecombinant urate oxidase rapidly controlled hyperuricaemia for prophylaxis and treatment in leukaemia/lymphoma patients.
[3] Recombinant urate oxidase (rasburicase) in the prevention and treatment of malignancy-associated hyperuricemia in pediatric and adult patients: results of a compassionate-use trial — Pui CH et al., Leukemia 2001. PMID: 11587206. View sourceStudy: Compassionate-use clinical trialRasburicase produced rapid and sustained uric acid reduction across pediatric and adult patients.
[4] Control of plasma uric acid in adults at risk for tumor Lysis syndrome: efficacy and safety of rasburicase alone and rasburicase followed by allopurinol compared with allopurinol alone - results of a multicenter phase III study — Cortes J et al., Journal of Clinical Oncology 2010. PMID: 20713865. View sourceStudy: Randomized, multicenter phase III trial (adults)Rasburicase, alone or followed by allopurinol, achieved higher uric acid response rates than allopurinol alone in adults.
[5] Recommendations for the evaluation of risk and prophylaxis of tumour lysis syndrome (TLS) in adults and children with malignant diseases: an expert TLS panel consensus — Cairo MS et al., British Journal of Haematology 2010. PMID: 20331465. View sourceStudy: Expert consensus guidelinePositions rasburicase as recommended management for high-risk tumour lysis syndrome, with G6PD screening cautions.
[6] Rasburicase-induced hemolytic anemia and methemoglobinemia: a systematic review of current reports — Hammami MB et al., Annals of Hematology 2024. PMID: 37468669. View sourceStudy: Systematic reviewDocuments haemolytic anaemia and methaemoglobinaemia after rasburicase, frequently linked to unrecognized G6PD deficiency.

This article is for educational and research purposes only. Peptides discussed here are not approved for human consumption by the FDA, EMA, or equivalent regulators outside of specific clinical contexts. Always consult a licensed medical professional before any therapeutic use.