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Rasburicase (Monograph)

Brand name: Elitek
Drug class: Enzymes
ATC class: V03AF07
VA class: GA500
Chemical name: urate (Aspergillus flavus clone 9C/9A reduced) oxidase
Molecular formula: C1523H2383N417O462S7 (monomer)
CAS number: 134774-45-1

Medically reviewed by on Feb 20, 2024. Written by ASHP.


  • Risk of severe hypersensitivity reactions (e.g., anaphylaxis). (See Hypersensitivity Reactions under Cautions.)

  • Immediately and permanently discontinue if clinical evidence of hypersensitivity reaction develops.

  • Risk of severe hemolysis in patients with a glucose-6-phosphate dehydrogenase (G-6-PD) deficiency. (See Hemolysis under Cautions.)

  • Immediately and permanently discontinue if hemolysis develops.

  • Screen patients at higher risk (e.g., patients of African or Mediterranean ancestry) prior to starting therapy.

  • Methemoglobinemia reported; immediately and permanently discontinue if methemoglobinemia develops. (See Methemoglobinemia under Cautions.)

    Interference with Uric Acid Measurements
  • Enzymatic degradation of uric acid occurs within blood samples left at room temperature, resulting in spuriously low uric acid levels.

  • Collect blood in prechilled tubes containing heparin anticoagulant and immediately immerse and maintain in an ice-water bath; assay plasma samples within 4 hours of collection. (See Specific Drugs and Laboratory Tests under Interactions.)


Biosynthethic (recombinant DNA origin) form of urate oxidase prepared from a genetically modified strain of Saccharomyces cerevisiae.

Uses for Rasburicase

Chemotherapy-induced Hyperuricemia

Initial management of plasma uric acid concentrations in pediatric patients with leukemia, lymphoma, or solid tumors who are receiving chemotherapy expected to result in tumor lysis and subsequent elevation of plasma uric acid concentrations.

Rasburicase Dosage and Administration



IV Administration

Administer by IV infusion.

Do not administer as a rapid IV injection (e.g., IV push or bolus).

Do not use filters during administration.

Infuse through a different line than that used for other concomitant drugs; if not possible, flush the line with at least 15 mL of 0.9% sodium chloride injection prior to and after infusion of rasburicase solutions.


Reconstitute prior to administration.

Determine number of vials needed to achieve the proper dosage based on the patient’s weight and the dose per kg.

Reconstitute vial containing 1.5 mg of rasburicase lyophilized powder with 1 mL of provided diluent (sterile water for injection and poloxamer 188) to provide a solution containing 1.5 mg of rasburicase per mL.

Mix by swirling very gently. Do not shake or form a vortex.

Must be diluted further before IV administration.


Use strict aseptic technique since drug product contains no preservatives.

Withdraw appropriate dose from reconstituted vials and add to the appropriate volume of 0.9% sodium chloride injection to achieve a final volume of 50 mL.

Rate of Administration

Administer diluted solution by IV infusion over 30 minutes.


Pediatric Patients

Chemotherapy-induced Hyperuricemia

Infants and children 1 month to 17 years of age: 0.15 or 0.2 mg/kg once daily for 5 days.

Safety and efficacy established only for a single course of treatment. (See Sensitivity Reactions under Cautions.)

Prescribing Limits

Pediatric Patients

Chemotherapy-induced Hyperuricemia

Infants and children 1 month to 17 years of age: Safety and efficacy of twice daily dosing, dosing for >5 days, or administration of >1 course of therapy not established.

Special Populations

No special populations dosing recommendations at this time.

Cautions for Rasburicase





Potential for severe (e.g., grade 3 or 4) hemolytic reactions associated with G-6-PD deficiency; reported within 2–4 days of initiation of therapy.

Immediately and permanently discontinue the drug if evidence of hemolysis appears; initiate appropriate patient monitoring and supportive measures (e.g., transfusion support).

Contraindicated in patients with G-6-PD deficiency because hydrogen peroxide is a major product of the conversion of uric acid to allantoin.

Prior to initiating therapy, screen patients at increased risk of G-6-PD deficiency (e.g., patients of African or Mediterranean descent).


Risk of methemoglobinemia, resulting in serious hypoxemia requiring medical intervention.

Immediately and permanently discontinue if methemoglobinemia develops and implement supportive measures (e.g., transfusion support, methylene blue administration).

Unknown whether a deficiency of cytochrome b5 reductase (methemoglobin reductase) or of other antioxidant enzymes increases risk for methemoglobinemia or hemolytic anemia.

Sensitivity Reactions

Hypersensitivity Reactions

Risk of severe hypersensitivity reactions (e.g., anaphylaxis); may occur any time during treatment, even during the first dose.

If a serious hypersensitivity reaction occurs(e.g., bronchospasm, chest pain and tightness, dyspnea, hypoxia, hypotension, shock, and/or urticaria), immediately and permanently discontinue drug and initiate appropriate therapy.

Safety in patients with atopic allergy or asthma is unknown.

General Precautions


Maintain adequate hydration according to standard medical practice for the management of plasma uric acid in patients at risk for tumor lysis syndrome. Alkalinization of the urine is not needed.


Antibodies to rasburicase may develop; may be associated with inhibition of rasburicase activity.

Specific Populations


Category C.


Not known whether rasburicase is distributed into milk; discontinue nursing or the drug.

Pediatric Use

Safety and efficacy not established in infants <1 month of age.

Geriatric Use

Insufficient experience in those ≥65 years of age to determine whether they respond differently than pediatric patients.

Adult Use

Insufficient experience in adults to determine whether they respond differently than pediatric patients.

Common Adverse Effects

Vomiting, fever, nausea, headache, abdominal pain, constipation, diarrhea, mucositis, rash.

Drug Interactions

Does not substantially induce or inhibit CYP isoenzymes including 1A, 2A, 2B, 2C, 2E, or 3A in vivo; clinically relevant pharmacokinetic interactions unlikely.

Specific Drugs and Laboratory Tests

Drug or Test




Pharmacokinetic interactions unlikely

Antineoplastic agents (cyclophosphamide, cytarabine, daunorubicin, etoposide, mercaptopurine, methotrexate, thioguanine, vincristine)

Pharmacokinetic interactions unlikely


Pharmacokinetic interactions unlikely

Test for uric acid

Interference with uric acid measurements due to enzymatic degradation of uric acid in blood/plasma/serum samples left at room temperature, resulting in spuriously low uric acid concentrations

Collect blood samples in prechilled test tubes containing heparin and immediately immerse in an ice water bath

Analyze uric acid concentrations in plasma; prepare plasma samples from whole blood by centrifugation in a precooled centrifuge (4°C) and assay within 4 hours of sample collection

Rasburicase Pharmacokinetics

Pharmacokinetics evaluated in pediatric patients; insufficient data available to evaluate pharmacokinetics in adults.



Age-adjusted target plasma uric acid concentrations (i.e., ≤6.5 mg/dL in children <13 years of age or ≤7.5 mg/dL in those ≥13 years of age) achieved within 48 hours following initiation of rasburicase therapy.


Target plasma uric acid concentrations maintained for 24 hours after the last administered rasburicase dose.



Not known whether rasburicase is distributed into milk.



18 hours.




Powder for Injection and Diluent

2–8°C. Do not freeze; protect from light.


Advice to Patients


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.



Dosage Forms


Brand Names



For IV infusion

1.5 mg



AHFS DI Essentials™. © Copyright 2024, Selected Revisions March 1, 2007. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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