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Drug ReportsRasburicase
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
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hemic and lymphatic diseasesD006425
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
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
ElitekrasburicaseSanofiN-103946 RX2002-07-12
2 products
Labels
FDA
EMA
Brand Name
Status
Last Update
elitekBiologic Licensing Application2024-10-04
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hyperuricemia—D033461—
tumor lysis syndrome—D015275E88.3
Agency Specific
FDA
EMA
Expiration
Code
rasburicase, Elitek, Sanofi-Aventis U.S. LLC
2109-07-12Orphan excl.
Patent Expiration
No data
ATC Codes
V: Various drug classes in atc
— V03: All other therapeutic products
— V03A: All other therapeutic products
— V03AF: Detoxifying agents for antineoplastic treatment
— V03AF07: Rasburicase
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
HyperuricemiaD033461———324110
Tumor lysis syndromeD015275—E88.31314210
LymphomaD008223—C85.913—216
LeukemiaD007938—C9513—115
SyndromeD013577——1212—5
NeoplasmsD009369—C80——11—2
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-hodgkin lymphomaD008228—C85.9—1———1
Metabolic diseasesD008659EFO_0000589E88.9—1———1
Nutritional and metabolic diseasesD009750———1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRasburicase
INNrasburicase
Description
Uricase (Urate oxidase)
Classification
Enzyme
Drug classenzymes
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL1201594
ChEBI ID—
PubChem CID—
DrugBankDB00049
UNII ID08GY9K1EUO (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,358 documents
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Safety
Black-box Warning
Black-box warning for: Elitek
Adverse Events
Top Adverse Reactions
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1,073 adverse events reported
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