Rasburicase

What it is and how it works

Mechanism of Action In humans, uric acid is the final step in the catabolic pathway of purines. Rasburicase catalyzes enzymatic oxidation of poorly soluble uric acid into an inactive and more soluble metabolite (allantoin).

Indications

Elitek is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. Elitek is a recombinant urate-oxidase indicated for initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. Limitations of use: Elitek is indicated only for a single course of treatment. Limitations of Use Elitek is indicated only for a single course of treatment .

Dosage and administration (summary)

Administer at 0.2 mg/kg as an intravenous infusion over 30 minutes daily for up to 5 days. Do not administer as an intravenous bolus. Dosage The recommended dose of Elitek is 0.2 mg/kg as a 30-minute intravenous infusion daily for up to 5 days. Dosing beyond 5 days or administration of more than one course is not recommended. Reconstitution Procedure Elitek must be reconstituted with the diluent provided in the carton. Reconstitute the 1.5 mg vial of Elitek with 1 mL of diluent. Reconstitute the 7.5 mg vial of Elitek with 5 mL of diluent. Mix by swirling gently. Do not shake or vortex.

Contraindications

Elitek is contraindicated in patients with a history of anaphylaxis or severe hypersensitivity to rasburicase or in patients with development of hemolytic reactions or methemoglobinemia with rasburicase . Elitek is contraindicated in individuals deficient in glucose-6-phosphate dehydrogenase (G6PD) . History of the following reactions to rasburicase: anaphylaxis, severe hypersensitivity, hemolysis, methemoglobinemia. Glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Warnings and precautions

Hypersensitivity Reactions Elitek can cause serious and fatal hypersensitivity reactions including anaphylaxis. In clinical studies, anaphylaxis was reported in <1% patients receiving Elitek. This can occur at any time during treatment including the first dose. Signs and symptoms of these reactions include bronchospasm, chest pain and tightness, dyspnea, hypoxia, hypotension, shock, and urticaria. Immediately and permanently discontinue Elitek administration in any patient developing clinical evidence of a serious hypersensitivity reaction .

Pregnancy

Pregnancy Risk Summary Based on findings in animals, Elitek may cause fetal harm when administered to pregnant women. In animal reproduction studies, intravenous administration of rasburicase to pregnant rabbits during organogenesis at 5-times the human exposure (based on AUC) at the recommended human dose of 0.2 mg/kg resulted in adverse developme…

Storage and supply

Storage and Handling The lyophilized drug product and the diluent for reconstitution should be stored at 2°C-8°C (36°F-46°F). Do not freeze. Protect from light.

Source: Rasburicase (Elitek) — US FDA prescribing information, 2026-07-30, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.