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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
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 Application2020-10-08
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hyperuricemiaD033461
tumor lysis syndromeD015275E88.3
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
28 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HyperuricemiaD0334613323213
Tumor lysis syndromeD015275E88.3121317
LymphomaD008223C85.923116
NeoplasmsD009369C80112
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.0213
Non-hodgkin lymphomaD008228C85.9112
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938C952315
Myelodysplastic syndromesD009190D46112
Burkitt lymphomaD002051C83.722
Myeloid leukemia acuteD015470C92.011
Nutritional and metabolic diseasesD00975011
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GoutD006073EFO_0004274M1033
Myeloproliferative disordersD009196D47.111
Graft vs host diseaseD006086D89.8111
Plasma cell neoplasmsD05421911
Healthy volunteers/patients11
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I1011
Oxidative stressD018384EFO_100190511
ObesityD009765EFO_0001073E66.911
Metabolic syndromeD024821EFO_0000195E88.8111
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)
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID134774-45-1
RxCUI283821
ChEMBL IDCHEMBL1201594
ChEBI ID
PubChem CID
DrugBankDB00049
UNII ID08GY9K1EUO (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
Mock data
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3,508 adverse events reported
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