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| Stem definition | Drug id | CAS RN |
|---|---|---|
| enzymes | 5138 | 9074-87-7 |
| Molecule | Description |
|---|---|
|
Synonyms:
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a recombinant bacterial enzyme that hydrolyzes the carboxylterminal glutamate residue from folic acid and classical antifolates such as methotrexate, provides an alternate non-renal pathway for methotrexate elimination in patients with renal dysfunction during high-dose methotrexate treatment
|
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Jan. 17, 2012 | FDA | BTG INTERNATIONAL INC | |
| Sept. 27, 2021 | PMDA | OHARA PHARMACEUTICAL CO., LTD | |
| Jan. 11, 2022 | EMA | SERB SAS |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Laboratory test interference | 154.21 | 119.48 | 18 | 159 | 662 | 90627608 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Laboratory test interference | 149.04 | 87.16 | 20 | 295 | 577 | 42620443 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Laboratory test interference | 284.35 | 75.43 | 37 | 482 | 1346 | 110587434 |
| False positive investigation result | 101.08 | 75.43 | 15 | 504 | 1399 | 110587381 |
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| Source | Code | Description |
|---|---|---|
| ATC | V03AF09 | VARIOUS ALL OTHER THERAPEUTIC PRODUCTS ALL OTHER THERAPEUTIC PRODUCTS Detoxifying agents for antineoplastic treatment |
| FDA CS | M0003411 | Carboxypeptidases |
| FDA EPC | N0000184013 | Carboxypeptidase |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Toxic plasma methotrexate concentration reduction | indication |
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| ID | Source |
|---|---|
| 2GFP9BJD79 | UNII |
| 4031567 | VANDF |
| C0007072 | UMLSCUI |
| CHEBI:750223 | CHEBI |
| CHEMBL1863515 | ChEMBL_ID |
| D10260 | KEGG_DRUG |
| 21195079 | PUBCHEM_CID |
| DB08898 | DRUGBANK_ID |
| 8509 | INN_ID |
| C000629556 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7450 | IUPHAR_LIGAND_ID |
| 1242127 | RXNORM |
| 186910 | MMSL |
| 27039 | MMSL |
| d07583 | MMSL |
| 014126 | NDDF |
| 130594006 | SNOMEDCT_US |
| 716225006 | SNOMEDCT_US |
| 763579008 | SNOMEDCT_US |
| 2GFP9BJD79 | INXIGHT DRUGS |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Voraxaze | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50633-210 | INJECTION, POWDER, FOR SOLUTION | 1000 [USPU] | INTRAVENOUS | BLA | 24 sections |