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Urate Oxidase


Drug Nomenclature

Synonyms: CB-8129; Uricasa; Uricase
CAS: 9002-12-4
ATC code: M04AX01

Rasburicase

(British Approved Name, US Adopted Name, rINN)
Drug Nomenclature
International Nonproprietary Names (INNs) in main languages (French, Latin, Russian, and Spanish):

Synonyms: Rasburicasa; Rasburicasum; Rasburikaasi; Rasburikas; SR-29142
BAN: Rasburicase
USAN: Rasburicase
INN: Rasburicase [rINN (en)]
INN: Rasburicasa [rINN (es)]
INN: Rasburicase [rINN (fr)]
INN: Rasburicasum [rINN (la)]
INN: Разбуриказа [rINN (ru)]
CAS: 134774-45-1
ATC code: V03AF07

Description. Rasburicase is a recombinant form of the enzyme urate oxidase.

Adverse Effects

The most serious adverse effects of rasburicase involve hypersensitivity reactions, including anaphylaxis, rashes, bronchospasm, rhinitis, urticaria, hypotension, dyspnoea, and chest pain and tightness. Haemolysis and methaemoglobinaemia have also been reported. Other adverse effects are nausea, vomiting, abdominal pain, constipation, diarrhoea, headache, fever, respiratory distress, sepsis, neutropenia, and mucositis.

Precautions

Treatment with rasburicase should be immediately and permanently stopped if hypersensitivity reactions, methaemoglobinaemia, or haemolysis develop. Rasburicase is contra-indicated in patients with G6PD deficiency or other cellular metabolic disorders known to cause haemolytic anaemia; hydrogen peroxide, which is produced during oxidation of uric acid to allantoin, can induce haemolytic anaemia in these patients. Patients at higher risk of having G6PD deficiency should be screened before receiving rasburicase.

Uses and Administration

Rasburicase is a recombinant form of the enzyme urate oxidase, which oxidises uric acid to allantoin. It is used in the treatment and prophylaxis of severe hyperuricaemia (p.552) associated with the treatment of malignancy. It is given by intravenous infusion before and during the start of chemotherapy, in a dose of 150 or 200 micrograms/kg daily over 30 minutes. Duration of treatment may vary from 5 to 7 days. The native form of urate oxidase has also been used.

Gout. Rasburicase has been used successfully to treat gout in patients allergic to allopurinol.

Tumour lysis syndrome. The tumour lysis syndrome represents a biochemical disturbance after massive release of cellular breakdown products from tumour cells sensitive to therapy; hyperuricaemia is a cardinal feature. Rasburicase was effective in the prophylaxis or treatment of hyperuricaemia in children and young adults with leukaemia or lymphoma who either presented with abnormally high plasma concentrations of uric acid or had large tumour cell burdens. Treatment was mostly well tolerated; one patient developed nausea and vomiting and one experienced bronchospasm and hypoxaemia 3 hours after infusion. Antibodies to rasburicase were seen in 17 of 121 assessable patients. Safety and efficacy were confirmed in further studies of children and adults considered to be at particularly high risk of tumour lysis syndrome. In children with haematologic malignancies at high risk for tumour lysis, rasburicase given intravenously achieved more rapid control and lower levels of plasma uric acid than oral allopurinol. No antibodies to rasburicase were detected at day 14. In 3 children with acute lymphoblastic leukaemia, hyperuricaemia was reportedly controlled with oral allopurinol and a single dose of rasburicase, although subclinical tumour lysis was apparent. Rasburicase has also been used for tumour lysis syndrome in neonates. One infant was given a single dose of rasburicase after 2 days of induction chemotherapy for neuroblastoma, started on day 21 of life; serum urate normalised and chemotherapy was completed without further incident. A second infant, with acute lymphoblastic leukaemia and renal dysfunction, presented with tumour lysis syndrome, and had 6 doses of intravenous rasburicase plus aggressive supportive therapy, but died of complications on day 7 of life. Reviews have concluded that rasburicase is highly effective at decreasing uric acid concentrations rapidly and thoroughly; there is some suggestion that shorter durations of treatment (between 1 and 3 days as opposed to 5 days) may be sufficient even in high-risk patients.

Single-ingredient Preparations

The symbol ¤ denotes a preparation which is discontinued or no longer actively marketed.

Australia: Fasturtec; Belgium: Fasturtec; Chile: Fasturtec¤; Czech Republic: Fasturtec; Denmark: Fasturtec; Finland: Fasturtec; France: Fasturtec; Uricozyme¤; Germany: Fasturtec; Greece: Fasturtec; Hong Kong: Fasturtec; Hungary: Fasturtec; Ireland: Fasturtec; Italy: Fasturtec; Uricozyme¤; Norway: Fasturtec; New Zealand: Fasturtec; Portugal: Fasturtec¤; Singapore: Fasturtec; Spain: Fasturtec; Sweden: Fasturtec; Switzerland: Fasturtec; United Kingdom: Fasturtec; United States: Elitek

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