| Stem definition | Drug id | CAS RN |
|---|---|---|
| enzymes | 5138 | 9074-87-7 |
| Molecule | Description |
|---|---|
|
Synonyms:
|
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
|
None
None
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Jan. 11, 2022 | EMA | SERB SAS | |
| Jan. 17, 2012 | FDA | BTG INTERNATIONAL INC | |
| Sept. 27, 2021 | PMDA | OHARA PHARMACEUTICAL CO., LTD |
| 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 | 115.43 | 91.89 | 14 | 126 | 632 | 63488250 |
| 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 | 129.09 | 94.54 | 17 | 221 | 463 | 34956230 |
| 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 | 226.56 | 94.45 | 30 | 370 | 1171 | 79742817 |
| False positive investigation result | 95.85 | 94.45 | 14 | 386 | 1098 | 79742890 |
None
| 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 |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Toxic plasma methotrexate concentration reduction | indication |
None
None
None
None
None
None
| ID | Source |
|---|---|
| 2GFP9BJD79 | UNII |
| 4031567 | VANDF |
| C0007072 | UMLSCUI |
| CHEMBL1863515 | ChEMBL_ID |
| D10260 | KEGG_DRUG |
| 21195079 | PUBCHEM_CID |
| DB08898 | DRUGBANK_ID |
| 8509 | INN_ID |
| 7450 | IUPHAR_LIGAND_ID |
| 1242127 | RXNORM |
| 186910 | MMSL |
| 27039 | MMSL |
| d07583 | MMSL |
| 014126 | NDDF |
| 130594006 | SNOMEDCT_US |
| 716225006 | SNOMEDCT_US |
| 763579008 | SNOMEDCT_US |
| C000629556 | MESH_SUPPLEMENTAL_RECORD_UI |
| 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 |
| Voraxaze | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50633-210 | INJECTION, POWDER, FOR SOLUTION | 1000 [USPU] | INTRAVENOUS | BLA | 24 sections |