Rasburicase

Reconstitute a vial labelled as containing 1.5 mg and 7.5 mg with 1 mL and 5 mL of provided diluent, respectively, to make a final concentration of 1.5 mg/mL. Gently swirl to mix; do not shake. Further dilute the required volume of reconstituted solution with NaCl 0.9% solution to prepare a final total volume of 50 mL.

Hypersensitivity. G6PD deficiency and other cellular metabolic disorders that cause haemolytic anaemia; history of haemolytic reaction or methaemoglobinaemia associated with rasburicase.

Patient with history of atopic allergies. Patients at risk of tumour lysis syndrome (TLS) must receive concomitant appropriate IV hydration in the management of plasma uric acid. Rasburicase is indicated as a single course of treatment only (given immediately before and during the initiation of chemotherapy); currently, available data is insufficient to recommend use in multiple treatment courses. Children. Pregnancy and lactation.

Significant: Severe haemolytic reactions; methaemoglobinaemia (which may result in serious hypoxaemia); anti-rasburicase antibody development.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain, constipation, mucositis.
General disorders and administration site conditions: Fever.
Infections and infestations: Sepsis.
Investigations: Increased ALT.
Metabolism and nutrition disorders: Peripheral oedema, hyperbilirubinaemia, hypophosphataemia, hyperphosphataemia.
Nervous system disorders: Headache, convulsion, involuntary muscle contraction.
Psychiatric disorders: Anxiety.
Respiratory, thoracic and mediastinal disorders: Bronchospasm, pharyngolaryngeal pain.
Skin and subcutaneous tissue disorders: Rashes, urticaria.
Vascular disorders: Hypotension.
Potentially Fatal: Serious hypersensitivity reactions, including anaphylaxis or anaphylactic shock.

Screen patients who are at high risk of G6PD deficiency (e.g. patients of Southeast Asian, Mediterranean or African descent) prior to treatment initiation. Monitor CBC; plasma uric acid levels (4 hours following administration, then every 6-8 hours until TLS resolution). Closely monitor for signs of hypersensitivity reactions, haemolysis, and methaemoglobinaemia.

Interferes with uric acid measurements by causing an enzymatic degradation of uric acid in blood/plasma/serum samples when placed at room temperature, leading to low uric acid assay reading; follow specific local guidelines for the collection and handling of samples to ensure result accuracy.

Description:
Mechanism of Action: Rasburicase, a recombinant form of urate oxidase enzyme, catalyses the oxidation of uric acid to form allantoin (a soluble and inactive uric acid metabolite). It does not block the formation of uric acid.
Onset: Plasma uric acid level reduction: Within 4 hours of initial administration.
Pharmacokinetics:
Distribution: Plasma uric acid level reduction: Within 4 hours of initial administration.
Excretion: Elimination half-life: Approx 16-23 hours.

Intact vial: Store between 2-8°C. Do not freeze. Protect from light. Reconstituted solution and diluted solution for infusion: Store between 2-8°C for up to 24 hours.

Antidotes & Detoxifying Agents / Supportive Care Therapy

V03AF07 - rasburicase ; Belongs to the class of detoxifying agents used in antineoplastic treatment.

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Elitek (Sanofi-Aventis U.S. LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 12/02/2025.

Fasturtec 1.5 mg/mL Powder and Solvent for Concentrate for Solution for Infusion (Aventis Pharma Limited Trading as Sanofi). MHRA. https://products.mhra.gov.uk. Accessed 12/02/2025.

Fasturtec 1.5 mg/mL Powder and Solvent for Concentrate for Solution for Infusion (Sanofi-Aventis Singapore Pte. Ltd.). MIMS Singapore. http://www.mims.com/singapore. Accessed 12/02/2025.

Joint Formulary Committee. Rasburicase. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 12/02/2025.

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics. Fasturtec 1.5 mg Powder for Infusion data sheet 20 June 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 12/02/2025.

Rasburicase. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 12/02/2025.