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| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5336 | 1262449-58-0 |
| Molecule | Description |
|---|---|
|
Synonyms:
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Andexanet alfa is a recombinant form of human FXa protein that has been modified to lack FXa enzymatic activity. The active site serine was substituted with alanine, rendering the molecule unable to cleave and activate prothrombin, and the gamma-carboxyglutamic acid (Gla) domain was removed to eliminate the ability of the protein to assemble into the prothrombinase complex, thus removing any anti-coagulant effects. Andexanet alfa is a specific reversal agent for FXa inhibitors. The predominant mechanism of action is the binding and sequestration of the FXa inhibitor, although there may be a minor contribution from the inhibition of tissue factor pathway inhibitor (TFPI) activity through binding to TFPI. The interaction between andexanet alfa and TFPI has not been fully characterized. Andexanet alfa binds direct FXa inhibitors with high affinity, making them unavailable to exert their anticoagulant effects
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| April 26, 2019 | EMA | Portola Netherlands BV | |
| May 3, 2018 | FDA | Portola Pharamceuticals US | |
| March 28, 2022 | PMDA | Alexion Pharma G.K. |
| 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 |
|---|---|---|---|---|---|---|
| Cerebral infarction | 352.43 | 105.91 | 67 | 404 | 26529 | 90601447 |
| Heparin resistance | 180.61 | 105.91 | 18 | 453 | 39 | 90627937 |
| 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 |
|---|---|---|---|---|---|---|
| Cerebral infarction | 242.88 | 80.64 | 62 | 594 | 31107 | 42589572 |
| Heparin resistance | 214.45 | 80.64 | 26 | 630 | 140 | 42620539 |
| 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 |
|---|---|---|---|---|---|---|
| Cerebral infarction | 580.63 | 80.44 | 129 | 1064 | 51709 | 110536397 |
| Heparin resistance | 370.42 | 80.44 | 43 | 1150 | 228 | 110587878 |
| Ischaemic stroke | 84.58 | 80.44 | 27 | 1166 | 41236 | 110546870 |
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| Source | Code | Description |
|---|---|---|
| ATC | V03AB38 | VARIOUS ALL OTHER THERAPEUTIC PRODUCTS ALL OTHER THERAPEUTIC PRODUCTS Antidotes |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Direct acting anticoagulant adverse reaction | indication | 293332005 |
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| ID | Source |
|---|---|
| BI009E452R | UNII |
| C4079904 | UMLSCUI |
| CHEBI:755267 | CHEBI |
| CHEMBL3301583 | ChEMBL_ID |
| DB14562 | DRUGBANK_ID |
| D11029 | KEGG_DRUG |
| 9883 | INN_ID |
| C580915 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7576 | IUPHAR_LIGAND_ID |
| 783678000 | SNOMEDCT_US |
| 783691004 | SNOMEDCT_US |
| 281836 | MMSL |
| 2045114 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| ANDEXXA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0310-3200 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 200 mg | INTRAVENOUS | BLA | 27 sections |