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.
Download report
Favorite
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| chemically-induced disorders | D064419 |
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 |
|---|---|---|---|---|---|
| Voraxaze | glucarpidase | BTG | N-125327 RX | 2012-01-17 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| voraxaze | Biologic Licensing Application | 2019-08-28 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
glucarpidase, Voraxaze, BTG International Inc. | |||
| 2119-01-17 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| C9293 | Injection, glucarpidase, 10 units |
Clinical
Clinical Trials
33 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 4 | 1 | 10 | 7 | 3 | 25 |
| Hyperglycemia | D006943 | HP_0003074 | R73.9 | — | — | — | 1 | 1 | 2 |
| Coronary artery disease | D003324 | I25.1 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic renal insufficiency | D051436 | N18 | — | — | 2 | — | 1 | 3 | |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | 1 | — | 1 | — | — | 2 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | 1 | — | — | 1 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | 1 | — | — | 1 |
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/patients | — | 4 | — | — | — | — | 4 | ||
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | 1 | — | — | — | 1 | 2 |
| Insulin resistance | D007333 | EFO_0002614 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | — | — | — | — | 1 | 1 | ||
| Genotype | D005838 | EFO_0000513 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | GLUCARPIDASE |
| INN | glucarpidase |
| 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 class | enzymes |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 9074-87-7 |
| RxCUI | 1242127 |
| ChEMBL ID | CHEMBL1863515 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB08898 |
| UNII ID | 2GFP9BJD79 (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
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 214 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
6,803 adverse events reported
View more details
Premium feature
Learn more about premium features at pharmakb.com
Learn more