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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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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 Application2023-08-18
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hyperuricemiaHP_0002149D033461—
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
71 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HyperuricemiaD033461HP_0002149—6754830
GoutD006073EFO_0004274M107694228
LymphomaD008223—C85.92622111
Tumor lysis syndromeD015275—E88.31315211
LeukemiaD007938—C952621110
SyndromeD013577——2413—9
Kidney diseasesD007674EFO_0003086N08—31159
Chronic renal insufficiencyD051436—N18—2—147
NeoplasmsD009369—C801—12—4
HypertensionD006973EFO_0000537I10———134
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-hodgkin lymphomaD008228—C85.9—21——3
Precursor cell lymphoblastic leukemia-lymphomaD054198———21——3
Lymphoid leukemiaD007945—C91—21——3
B-cell lymphomaD016393———11——1
Iga glomerulonephritisD005922EFO_0004194——11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelodysplastic syndromesD009190—D4611———2
PreleukemiaD011289——11———2
B-cell chronic lymphocytic leukemiaD015451—C91.1—2———2
Burkitt lymphomaD002051—C83.7—2———2
Asymptomatic diseasesD058070———1———1
Large b-cell lymphoma diffuseD016403—C83.3—1———1
Plasmablastic lymphomaD000069293—C83.3—1———1
Large-cell lymphoma immunoblasticD016400———1———1
B-cell leukemiaD015448———1———1
Myeloid leukemia acuteD015470—C92.0—1———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myeloproliferative disordersD009196—D47.11————1
Multiple myelomaD009101—C90.01————1
Graft vs host diseaseD006086—D89.811————1
Myelodysplastic-myeloproliferative diseasesD054437——1————1
Plasma cell neoplasmsD054219——1————1
PlasmacytomaD010954—C90.31————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-eclampsiaD011225EFO_0000668O14————22
Pregnancy-induced hypertensionD046110—O13————22
Drug-related side effects and adverse reactionsD064420—T88.7————11
Oxidative stressD018384EFO_1001905—————11
ObesityD009765EFO_0001073E66.9————11
Insulin resistanceD007333HP_0000855—————11
Metabolic syndromeD024821EFO_0000195E88.810————11
Cardiovascular diseasesD002318HP_0001626—————11
EclampsiaD004461HP_0100601O15————11
InfertilityD007246HP_0000789—————11
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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 3,184 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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