Elitek, Fasturtec(rasburicase)
Elitek, Fasturtec (rasburicase) is an enzyme pharmaceutical. Rasburicase was first approved as Fasturtec on 2001-02-23. It is used to treat hyperuricemia and tumor lysis syndrome in the USA. It has been approved in Europe to treat hyperuricemia.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Elitek
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| elitek | Biologic Licensing Application | 2024-10-04 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hyperuricemia | HP_0002149 | D033461 | — |
| tumor lysis syndrome | — | D015275 | E88.3 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
rasburicase, Elitek, Sanofi-Aventis U.S. LLC | |||
| 2109-07-12 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J2783 | Injection, rasburicase, 0.5 mg |
Clinical
Clinical Trials
72 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperuricemia | D033461 | HP_0002149 | — | 7 | 7 | 5 | 4 | 8 | 31 |
| Gout | D006073 | EFO_0004274 | M10 | 8 | 6 | 9 | 4 | 2 | 29 |
| Lymphoma | D008223 | — | C85.9 | 2 | 6 | 2 | 2 | 1 | 11 |
| Tumor lysis syndrome | D015275 | — | E88.3 | 1 | 3 | 1 | 5 | 2 | 11 |
| Leukemia | D007938 | — | C95 | 2 | 6 | 2 | 1 | 1 | 10 |
| Syndrome | D013577 | — | — | 2 | 4 | 1 | 3 | — | 9 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 3 | 1 | 1 | 5 | 9 |
| Chronic renal insufficiency | D051436 | — | N18 | — | 2 | — | 1 | 4 | 7 |
| Neoplasms | D009369 | — | C80 | 1 | — | 1 | 2 | — | 4 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | 1 | 3 | 4 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-hodgkin lymphoma | D008228 | — | C85.9 | — | 2 | 1 | — | — | 3 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | — | 2 | 1 | — | — | 3 |
| Lymphoid leukemia | D007945 | — | C91 | — | 2 | 1 | — | — | 3 |
| B-cell lymphoma | D016393 | — | — | — | 1 | 1 | — | — | 1 |
| Iga glomerulonephritis | D005922 | EFO_0004194 | — | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | 1 | — | — | — | 2 |
| Preleukemia | D011289 | — | — | 1 | 1 | — | — | — | 2 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | — | 2 | — | — | — | 2 |
| Burkitt lymphoma | D002051 | — | C83.7 | — | 2 | — | — | — | 2 |
| Asymptomatic diseases | D058070 | — | — | — | 1 | — | — | — | 1 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | — | 1 | — | — | — | 1 |
| Plasmablastic lymphoma | D000069293 | — | C83.3 | — | 1 | — | — | — | 1 |
| Large-cell lymphoma immunoblastic | D016400 | — | — | — | 1 | — | — | — | 1 |
| B-cell leukemia | D015448 | — | — | — | 1 | — | — | — | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | — | 1 | — | — | — | 1 |
Show 10 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloproliferative disorders | D009196 | — | D47.1 | 1 | — | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | — | — | — | — | 1 |
| Graft vs host disease | D006086 | — | D89.81 | 1 | — | — | — | — | 1 |
| Myelodysplastic-myeloproliferative diseases | D054437 | — | — | 1 | — | — | — | — | 1 |
| Plasma cell neoplasms | D054219 | — | — | 1 | — | — | — | — | 1 |
| Plasmacytoma | D010954 | — | C90.3 | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | — | — | — | — | 2 | 2 |
| Pregnancy-induced hypertension | D046110 | — | O13 | — | — | — | — | 2 | 2 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | — | — | 1 | 1 |
| Oxidative stress | D018384 | EFO_1001905 | — | — | — | — | — | 1 | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
| Insulin resistance | D007333 | HP_0000855 | — | — | — | — | — | 1 | 1 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | — | — | — | 1 | 1 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | — | — | 1 | 1 |
| Eclampsia | D004461 | HP_0100601 | O15 | — | — | — | — | 1 | 1 |
| Infertility | D007246 | HP_0000789 | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Rasburicase |
| INN | rasburicase |
| Description | Uricase (Urate oxidase) |
| Classification | Enzyme |
| Drug class | enzymes |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201594 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00049 |
| UNII ID | 08GY9K1EUO (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
PubMed Central
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Additional graphs summarizing 3,218 documents
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Safety
Black-box Warning
Black-box warning for: Elitek
Adverse Events
Top Adverse Reactions
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986 adverse events reported
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