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
Trade Name
FDA
EMA
Elitek
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Rasburicase
Tradename | Proper name | Company | Number | Date | Products |
---|---|---|---|---|---|
Elitek | rasburicase | Sanofi | N-103946 RX | 2002-07-12 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
elitek | Biologic Licensing Application | 2020-10-08 |
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
28 clinical trials
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 1 | 1 |
Oxidative stress | D018384 | EFO_1001905 | — | — | — | — | 1 | 1 | |
Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | — | — | — | 1 | 1 |
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 | 134774-45-1 |
RxCUI | 283821 |
ChEMBL ID | CHEMBL1201594 |
ChEBI ID | — |
PubChem CID | — |
DrugBank | DB00049 |
UNII ID | 08GY9K1EUO (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,139 documents
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Safety
Black-box Warning
Black-box warning for: Elitek
Adverse Events
Top Adverse Reactions
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3,508 adverse events reported
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