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| Stem definition | Drug id | CAS RN |
|---|---|---|
| enzymes | 5216 | 1349719-22-7 |
| Molecule | Description |
|---|---|
|
Synonyms:
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Asparaginase Erwinia chrysanthemi catalyzes the deamidation of asparagine to aspartic acid and ammonia, resulting in a reduction in circulating levels of asparagine. The mechanism of action of ERWINAZE is thought to be based on the inability of leukemic cells to synthesize asparagine due to lack of asparagine synthetase activity, resulting in cytotoxicity specific for leukemic cells that depend on an exogenous source of amino acid asparagine for their protein metabolism and survival.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Nov. 18, 2011 | FDA | JAZZ PHARMS INC | |
| Sept. 15, 2023 | EMA | Jazz Pharmaceuticals Ireland Limited |
| 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 |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 182.57 | 62.97 | 56 | 431 | 158293 | 90469667 |
| 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 |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 70.63 | 35.38 | 46 | 887 | 185657 | 42434745 |
| Hyperammonaemia | 61.40 | 35.38 | 17 | 916 | 7849 | 42612553 |
| 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 |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 213.21 | 38.54 | 96 | 1345 | 316671 | 110271187 |
| Hyperammonaemia | 103.86 | 38.54 | 26 | 1415 | 13706 | 110574152 |
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| Source | Code | Description |
|---|---|---|
| MeSH PA | D000970 | Antineoplastic Agents |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Acute lymphoid leukemia | indication | 91857003 | DOID:9952 |
| Precursor cell lymphoblastic lymphoma | indication | 1217301006 | |
| Pancreatitis | contraindication | 75694006 | DOID:4989 |
| Thrombosis | contraindication | 439127006 |
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| ID | Source |
|---|---|
| C0003993 | UMLSCUI |
| CHEBI:753844 | CHEBI |
| CHEMBL2108931 | ChEMBL_ID |
| DB08886 | DRUGBANK_ID |
| D10517 | KEGG_DRUG |
| CHEMBL1863514 | ChEMBL_ID |
| 7347 | IUPHAR_LIGAND_ID |
| C000718243 | MESH_SUPPLEMENTAL_RECORD_UI |
| 370893003 | SNOMEDCT_US |
| 398689003 | SNOMEDCT_US |
| D001215 | MESH_DESCRIPTOR_UI |
| 9538 | INN_ID |
| 186148 | MMSL |
| 73540 | MMSL |
| d05689 | MMSL |
| 004466 | NDDF |
| D733ET3F9O | UNII |
| 1232186 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| ERWINASE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 81561-413 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 10000 [iU] | INTRAMUSCULAR | Unapproved drug for use in drug shortage | 3 sections |