Rasburicase

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).

• 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.ICD-10: C85.90, C95.90

• 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 [see Boxed Warning , Warnings and Precautions (5.1 , 5.2 , 5.3) ] . Elitek is contraindicated in individuals deficient in glucose-6-phosphate dehydrogenase (G6PD) [see Boxed Warning , Warnings and Precautions (5.2) ] .contraindicated

Administer at 0.2 mg/kg as an intravenous infusion over 30 minutes daily for up to 5 days. ( 2.1 ) Do not administer as an intravenous bolus. ( 2.3 ) 2.1 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. 2.2 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. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard solution if particulate matter is visible or product is discolored. 2.3 Further Dilution and Administration Administer Elitek as an intravenous infusion only: Inject the calculated dose of reconstituted Elitek solution into an infusion bag containing the appropriate volume of 0.9% sterile sodium chloride, to achieve a final total volume of 50 mL. Infuse over 30 minutes through a separate line or flush line with at least 15 mL of normal saline prior to and after Elitek infusion. Do not use filters during infusion of reconstituted Elitek drug product. Store reconstituted or diluted solution at 2°C–8°C. Discard unused product solution 24 hours following reconstitution.

5.1 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 [see Boxed Warning , Contraindications (4) , Adverse Reactions (6.2) ] . The safety and efficacy of Elitek have been established only for a single course of treatment once daily for 5 days. 5.2 Hemolysis Elitek is contraindicated in patients with G6PD deficiency because hydrogen peroxide is one of the major by-products of the conversion of uric acid to allantoin. In clinical studies, hemolysis occurs in <1% patients receiving Elitek; severe hemolytic reactions occurred within 2–4 days of the start of Elitek. Immediately and permanently discontinue Elitek administration in any patient developing hemolysis. Institute appropriate patient monitoring and support measures (e.g., transfusion support). Screen patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) prior to starting Elitek [see Boxed Warning , Contraindications (4) ] . 5.3 Methemoglobinemia In clinical studies, methemoglobinemia occurred in <1% patients receiving Elitek.

The following clinically significant adverse reactions are discussed in greater detail in other sections of the prescribing information: Anaphylaxis [see Boxed Warning , Contraindications (4) , Warnings and Precautions (5.1) ] Hemolysis [see Boxed Warning , Contraindications (4) , Warnings and Precautions (5.2) ] Methemoglobinemia [see Boxed Warning , Contraindications (4) , Warnings and Precautions (5.3) ] Most common adverse reactions (incidence ≥20%), when used concomitantly with anticancer therapy are vomiting, nausea, fever, peripheral edema, anxiety, headache, abdominal pain, constipation, diarrhea, hypophosphatemia, pharyngolaryngeal pain, and increased alanine aminotransferase. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data below reflect exposure to Elitek in 265 pediatric and 82 adult patients enrolled in one active-controlled trial (Study 1), two uncontrolled trials (Studies 2 and 3), and an uncontrolled safety trial (n=82). Additional data were obtained from an expanded access program of 356 patients, for whom data collection was limited to serious adverse reactions.

Pregnancy: May cause fetal harm. ( 8.1 ) Lactation: Breastfeeding not recommended. ( 8.2 ) 8.1 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 developmental outcomes, including structural abnormalities, embryo-fetal mortality, and alterations to growth (see Data ) . The limited available data with Elitek use in pregnant women are insufficient to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal fetal outcomes. Consider the benefits and risks of Elitek and possible risks to the fetus when prescribing Elitek to a pregnant woman. The estimated background risk of major birth defects and miscarriage in the indicated population is unknown. All pregnancies have a background risk of birth defect, miscarriage, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Metabolism

The pharmacokinetics of rasburicase was evaluated in both pediatric and adult patients with leukemia, lymphoma or other hematological malignancies. Rasburicase exposure, as measured by AUC 0–24 hr and C max , tended to increase with a dose range from 0.15 to 0.2 mg/kg.

Of the six reported cases of overdosage, five cases had no adverse events reported; nonserious adverse events in the sixth case (a single dose of 1.3 mg/kg) included decreased levels of blood potassium and blood albumin, and increased levels of carbon dioxide, blood lactate dehydrogenase, blood urea, blood phosphorus, blood sodium, and blood alkaline phosphatase. Monitor patients who receive an overdose and initiate supportive measures if required.

• Jul 12, 2002BLABLA103946Sanofi Synthelabo

1. 1Tumour Lysis Syndrome35515%
2. 2Off Label Use1908.2%
3. 3Febrile Neutropenia1857.9%
4. 4Pyrexia1446.2%
5. 5Acute Kidney Injury1406.0%
6. 6Drug Ineffective1325.7%
7. 7Neutropenia1275.4%
8. 8Cytokine Release Syndrome1165.0%
9. 9Sepsis1014.3%
10. 10Respiratory Failure903.9%
11. 11Hypotension873.7%
12. 12Anaemia853.6%
13. 13Multiple Organ Dysfunction Syndrome783.3%
14. 14Pneumonia773.3%
15. 15Renal Failure773.3%

The 10 most recently updated of 38 ClinicalTrials.gov registrations naming Rasburicase as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Mature B-Cell Lymphoma And Leukemia Study III
  Active not recruiting · Phase 2 · Phase 3 · Interventional · 128 enrolled · St. Jude Children's Research Hospital
  NCT01046825updated 2026-06-02
• Evaluation of Efficacy and Safety of AR882 and XOI Co-administration in Uricase Treatment Failed Patients
  Active not recruiting · Phase 2 · Interventional · 15 enrolled · Arthrosi Therapeutics
  NCT07116746updated 2026-05-15
• A Study of IN026 in Participants With Refractory Gout
  Not yet recruiting · Phase 1 · Interventional · 16 enrolled · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  NCT07587684updated 2026-05-14
• Pegloticase for the Reduction of Uric Acid in Patients With Tumor Lysis Syndrome
  Completed · Phase 4 · Interventional · 10 enrolled · M.D. Anderson Cancer Center
  NCT04745910updated 2026-05-06
• Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease
  Terminated · Phase 2 · Interventional · 19 enrolled · Allena Pharmaceuticals
  NCT04987294updated 2023-06-23
• An Inpatient Study of ALLN-346 (Engineered Urate Oxidase) in Hyperuricemic Subjects (Study 201)
  Completed · Phase 2 · Interventional · 16 enrolled · Allena Pharmaceuticals
  NCT04987242updated 2023-06-22
• Rasburicase Treatment in Chronic Gouty Arthritis
  Unknown · Phase 4 · Interventional · 60 enrolled · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  NCT05312268updated 2023-05-09
• Treatment of Hyperuricemia With Rasburicase in Patients With Acute Lymphoblastic Leukemia or High Grade Lymphoma
  Completed · Phase 3 · Interventional · 80 enrolled · Goethe University
  NCT00199043updated 2023-03-17
• Scintigraphy Study in Healthy Volunteers to Characterize the Performance of ALLN-346 Tablets
  Completed · Phase 1 · Interventional · 12 enrolled · Allena Pharmaceuticals
  NCT05168683updated 2023-01-23
• Evaluate the Efficacy and Safety of Rasburicase (Fasturtec®) in the Prevention and Treatment of Hyperuricemia in Pediatric Patients With Non-Hodgkin's Lymphoma and Acute Leukemia
  Completed · Phase 4 · Interventional · 50 enrolled · Sanofi
  NCT04349306updated 2022-04-25

CPIC-curated drug–gene pairs for Rasburicase. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• G6PDCPIC AClinPGx 1AFDA label: Testing Required
  G6PD

Frequently asked questions

How does Rasburicase work?

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).

What is Rasburicase used for?

According to FDA labeling, Rasburicase carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Rasburicase?

Rasburicase is classified as Detoxifying agents for antineoplastic treatment, Uric Acid-specific Enzyme, Enzyme Activators, Decreased Uric Acid Synthesis.

What are the brand names for Rasburicase?

Rasburicase is marketed under brand names including Elitek.

What are the contraindications for Rasburicase?

Rasburicase labeling lists contraindications including: 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 [see Boxed Warning , Warnings and Precautions (5.1 , 5.2 , 5.3) ] . Elitek is contraindicated in individuals deficient in glucose-6-phosphate dehydrogenase (G6PD) [see Boxed Warning , Warnings and Precautions (5.2) ] .. Always consult the full prescribing information and a clinician.