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Voraxaze(glucarpidase)
Voraxaze (glucarpidase) is an enzyme pharmaceutical. Glucarpidase was first approved as Voraxaze on 2012-01-17. It has been approved in Europe to treat metabolic side effects of drugs and substances.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
chemically-induced disordersD064419
Trade Name
FDA
EMA
Voraxaze
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)
Glucarpidase
Tradename
Proper name
Company
Number
Date
Products
VoraxazeglucarpidaseBTGN-125327 RX2012-01-17
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
voraxazeBiologic Licensing Application2019-08-28
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
glucarpidase, Voraxaze, BTG International Inc.
2119-01-17Orphan 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
V03AF09: Glucarpidase
HCPCS
Code
Description
C9293
Injection, glucarpidase, 10 units
Clinical
Clinical Trials
33 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
Type 2 diabetes mellitusD003924EFO_0001360E1141107325
HyperglycemiaD006943HP_0003074R73.9112
Coronary artery diseaseD003324I25.111
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic renal insufficiencyD051436N18213
AtherosclerosisD050197EFO_0003914I25.1112
Chronic kidney failureD007676EFO_0003884N18.611
Diabetes mellitusD003920EFO_0000400E08-E1311
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients44
Cardiovascular diseasesD002318EFO_0000319I98112
Insulin resistanceD007333EFO_000261411
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PharmacokineticsD01059911
GenotypeD005838EFO_000051311
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameGLUCARPIDASE
INNglucarpidase
Description
Glucarpidase (Voraxaze) is a medication used for the treatment of elevated levels of methotrexate (defined as 1 micromol/L) during treatment of cancer patients who have impaired kidney function (and thus cannot reduce the drug to safe levels sufficiently after the drug has been given). Glucarpidase is an enzyme that inactivates methotrexate rapidly after injection. Because this agent reduces systemic levels of methotrexate and could therefore interfere with efficacy, it is not recommended for use in patients with normal or only slightly impaired kidney function or in whom serum levels are normal. The main antidote for methotrexate overdoses prior to the approval of this drug were high doses of folinic acid. However, this agent was not always sufficient at preventing kidney failure due to methotrexate. Glucarpidase also degrades folinic acid so the two should not be used together (within two hours of one another).
Classification
Enzyme
Drug classenzymes
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID9074-87-7
RxCUI1242127
ChEMBL IDCHEMBL1863515
ChEBI ID
PubChem CID
DrugBankDB08898
UNII ID2GFP9BJD79 (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:
Mock data
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Additional graphs summarizing 214 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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6,803 adverse events reported
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