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 disorders | D064419 |
Trade Name
FDA
EMA
Voraxaze
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| voraxaze | Biologic Licensing Application | 2024-11-27 |
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
34 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 1 | — | 1 | — | — | 2 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | — | — | 1 | — | 1 | 2 |
| Lymphoid leukemia | D007945 | — | C91 | — | — | 1 | — | 1 | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | — | C61 | 3 | 9 | — | — | 1 | 13 |
| Adenocarcinoma | D000230 | — | — | 2 | 5 | — | — | — | 7 |
| Lymphoma | D008223 | — | C85.9 | 4 | 3 | — | — | 1 | 6 |
| Neoplasms | D009369 | — | C80 | 2 | 3 | — | — | 2 | 6 |
| Osteosarcoma | D012516 | — | — | 2 | 2 | — | — | — | 4 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 1 | 3 | — | — | — | 4 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 1 | 2 | — | — | — | 2 |
| Neurotoxicity syndromes | D020258 | — | G92 | 1 | 1 | — | — | 1 | 2 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | 1 | — | — | 1 | 2 |
| Bone neoplasms | D001859 | EFO_0003820 | D16 | 1 | 1 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Central nervous system neoplasms | D016543 | — | — | 1 | — | — | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
| Neurilemmoma | D009442 | EFO_0000693 | — | 1 | — | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | — | — | — | — | 1 |
| Lung neoplasms | D008175 | — | C34.90 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acute kidney injury | D058186 | — | N17 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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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 | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1863515 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB08898 |
| UNII ID | 2GFP9BJD79 (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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307 adverse events reported
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