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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
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
28 clinical trials
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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
LymphomaD008223C85.923—116
NeoplasmsD009369C80——11—2
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.0—21——3
Non-hodgkin lymphomaD008228C85.9—11——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938C9523——15
Myelodysplastic syndromesD009190D4611———2
Burkitt lymphomaD002051C83.7—2———2
Myeloid leukemia acuteD015470C92.0—1———1
Nutritional and metabolic diseasesD009750—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GoutD006073EFO_0004274M103————3
Myeloproliferative disordersD009196D47.11————1
Graft vs host diseaseD006086D89.811————1
Plasma cell neoplasmsD0542191————1
Healthy volunteers/patients—1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I10————11
Oxidative stressD018384EFO_1001905————11
ObesityD009765EFO_0001073E66.9————11
Metabolic syndromeD024821EFO_0000195E88.81————11
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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