Prescription medicine
Rasburicase Brand names: Elitek
Rasburicase (Elitek) is a prescription medicine with an FDA approval on record since 2002. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the rasburicase FDA label on DailyMed (effective July 30, 2026, Sanofi-Aventis U.S. LLC); the BLA 103946 record on Drugs@FDA; every rasburicase label on DailyMed.
Highlights of the record
FDA label of July 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
HYPERSENSITIVITY REACTIONS, HEMOLYSIS, METHEMOGLOBINEMIA, AND INTERFERENCE WITH URIC ACID MEASUREMENTS WARNING: HYPERSENSITIVITY REACTIONS, HEMOLYSIS, METHEMOGLOBINEMIA, AND INTERFERENCE WITH URIC ACID MEASUREMENTS.
See full prescribing information for complete boxed warning. Hypersensitivity Reactions: Elitek can cause serious and fatal hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue Elitek if a serious hypersensitivity reaction occurs ( 4 , 5.1 , 6.2 ). Hemolysis: Do not administer Elitek to patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Immediately and permanently discontinue Elitek if hemolysis occurs. Screen patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) prior to starting Elitek therapy ( 4 , 5.2 ). Methemoglobinemia: Elitek can result in methemoglobinemia in some patients. Immediately and permanently discontinue Elitek if methemoglobinemia occurs ( 4 , 5.3 ). Interference with uric acid measurements: Elitek enzymatically degrades uric acid in blood samples left at room temperature. Collect blood samples in prechilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. Assay plasma samples within 4 hours of collection ( 5.4 ). […]
Used for
From the label: indications and usageElitek 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.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- July 12, 2002 Elitek, Sanofi Synthelabo; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2020 0 Class I among all firms' recalls; latest August 10, 2020
- FAERS reports
- 2,410 through July 30, 2026
What is rasburicase used for?
From the label: indications and usageElitek 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. ( 1 ) Limitations of use: Elitek is indicated only for a single course of treatment. […]
Source: FDA drug label (Elitek), Sanofi-Aventis U.S. LLC, effective July 30, 2026 (SPL set 0ae10bc4-6b65-402f-9db5-2d7753054922), via openFDA; the full label on DailyMed
Is there a generic for rasburicase (Elitek)?
No generic rasburicase is approved (Drugs@FDA, October 8, 2026).
- 2002 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has rasburicase been recalled?
The FDA's Enforcement Report lists 1 recall naming rasburicase since 2020: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 10, 2020 | Class II | Sanofi-Aventis U.S. LLC | Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the rasburicase label say about other medicines?
The rasburicase label names 12 other medicines in its interaction, contraindication or warning sections. The labels of 13 other medicines name rasburicase. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Allantoin | warnings and precautions | 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. |
| Allopurinol | drug interactions | Rasburicase does not metabolize allopurinol, cytarabine, methylprednisolone, methotrexate, 6-mercaptopurine, thioguanine, etoposide, daunorubicin, cyclophosphamide or vincristine in vitro. |
| Cyclophosphamide | drug interactions | Rasburicase does not metabolize allopurinol, cytarabine, methylprednisolone, methotrexate, 6-mercaptopurine, thioguanine, etoposide, daunorubicin, cyclophosphamide or vincristine in vitro. |
| Cytarabine | drug interactions | Rasburicase does not metabolize allopurinol, cytarabine, methylprednisolone, methotrexate, 6-mercaptopurine, thioguanine, etoposide, daunorubicin, cyclophosphamide or vincristine in vitro. |
| Daunorubicin | drug interactions | Rasburicase does not metabolize allopurinol, cytarabine, methylprednisolone, methotrexate, 6-mercaptopurine, thioguanine, etoposide, daunorubicin, cyclophosphamide or vincristine in vitro. |
| Etoposide | drug interactions | Rasburicase does not metabolize allopurinol, cytarabine, methylprednisolone, methotrexate, 6-mercaptopurine, thioguanine, etoposide, daunorubicin, cyclophosphamide or vincristine in vitro. |
| Heparin | boxed warning | Collect blood samples in prechilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. |
| Hydrogen peroxide | warnings and precautions | 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. |
| Methotrexate | drug interactions | Rasburicase does not metabolize allopurinol, cytarabine, methylprednisolone, methotrexate, 6-mercaptopurine, thioguanine, etoposide, daunorubicin, cyclophosphamide or vincristine in vitro. |
| Methylprednisolone | drug interactions | Rasburicase does not metabolize allopurinol, cytarabine, methylprednisolone, methotrexate, 6-mercaptopurine, thioguanine, etoposide, daunorubicin, cyclophosphamide or vincristine in vitro. |
| Thioguanine | drug interactions | Rasburicase does not metabolize allopurinol, cytarabine, methylprednisolone, methotrexate, 6-mercaptopurine, thioguanine, etoposide, daunorubicin, cyclophosphamide or vincristine in vitro. |
| Vincristine | drug interactions | Rasburicase does not metabolize allopurinol, cytarabine, methylprednisolone, methotrexate, 6-mercaptopurine, thioguanine, etoposide, daunorubicin, cyclophosphamide or vincristine in vitro. |
Other labels that name rasburicase
Source: FDA drug label (Elitek), Sanofi-Aventis U.S. LLC, effective July 30, 2026 (SPL set 0ae10bc4-6b65-402f-9db5-2d7753054922), via openFDA; the full label on DailyMed
What do FAERS reports show for rasburicase?
The FDA Adverse Event Reporting System holds 2,410 reports that list rasburicase among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 659 are coded as a death and 1,295 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Rasburicase side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other