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bivalirudin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| hirudin derivatives | 385 | 128270-60-0 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
designed to bind to the alpha-thrombin catalytic site and anion-binding exosite for fibrin(ogen) recognition
|
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.25 | g | P |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| Vd (Volume of distribution) | 0.27 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 8.10 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 1 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 0.42 hours | Lombardo F, Berellini G, Obach RS |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 15, 2000 | FDA | MEDICINES CO |
FDA Adverse Event Reporting System (Female)
| 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 |
|---|---|---|---|---|---|---|
| Heparin-induced thrombocytopenia | 136.43 | 68.94 | 25 | 658 | 5287 | 90622477 |
| Thrombosis in device | 115.53 | 68.94 | 20 | 663 | 3055 | 90624709 |
| Vascular stent thrombosis | 90.00 | 68.94 | 14 | 669 | 1102 | 90626662 |
| Drug ineffective | 82.46 | 68.94 | 73 | 610 | 1384225 | 89243539 |
| Coronary artery thrombosis | 82.30 | 68.94 | 13 | 670 | 1129 | 90626635 |
FDA Adverse Event Reporting System (Male)
| 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 |
|---|---|---|---|---|---|---|
| Thrombosis in device | 176.14 | 61.37 | 35 | 1123 | 3111 | 42617066 |
| Heparin-induced thrombocytopenia | 166.36 | 61.37 | 38 | 1120 | 6559 | 42613618 |
| Vascular stent thrombosis | 139.56 | 61.37 | 29 | 1129 | 3213 | 42616964 |
| Drug ineffective | 106.02 | 61.37 | 105 | 1053 | 630092 | 41990085 |
| Coronary artery thrombosis | 101.54 | 61.37 | 21 | 1137 | 2265 | 42617912 |
| Coagulation time abnormal | 95.52 | 61.37 | 13 | 1145 | 101 | 42620076 |
| Kounis syndrome | 66.82 | 61.37 | 16 | 1142 | 3352 | 42616825 |
| Acute myocardial infarction | 66.24 | 61.37 | 32 | 1126 | 58133 | 42562044 |
| Oesophageal ulcer haemorrhage | 65.66 | 61.37 | 11 | 1147 | 372 | 42619805 |
FDA Adverse Event Reporting System (Geriatric)
| 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 |
|---|---|---|---|---|---|---|
| Heparin-induced thrombocytopenia | 274.60 | 60.50 | 58 | 1792 | 11366 | 110576083 |
| Thrombosis in device | 223.29 | 60.50 | 43 | 1807 | 5284 | 110582165 |
| Vascular stent thrombosis | 221.04 | 60.50 | 41 | 1809 | 4120 | 110583329 |
| Drug ineffective | 157.16 | 60.50 | 156 | 1694 | 1520384 | 109067065 |
| Coronary artery thrombosis | 140.91 | 60.50 | 27 | 1823 | 3217 | 110584232 |
| Coagulation time abnormal | 111.26 | 60.50 | 15 | 1835 | 184 | 110587265 |
| Acute myocardial infarction | 95.86 | 60.50 | 40 | 1810 | 83737 | 110503712 |
| Haemorrhage | 80.36 | 60.50 | 38 | 1812 | 106654 | 110480795 |
| Thrombosis | 79.69 | 60.50 | 38 | 1812 | 108624 | 110478825 |
| Cardiac tamponade | 64.28 | 60.50 | 18 | 1832 | 11289 | 110576160 |
| Pharyngeal haemorrhage | 62.87 | 60.50 | 12 | 1838 | 1395 | 110586054 |
| Oesophageal ulcer haemorrhage | 60.96 | 60.50 | 11 | 1839 | 941 | 110586508 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | B01AE06 | BLOOD AND BLOOD FORMING ORGANS ANTITHROMBOTIC AGENTS ANTITHROMBOTIC AGENTS Direct thrombin inhibitors |
| FDA MoA | N0000009963 | Thrombin Inhibitors |
| FDA EPC | N0000175518 | Direct Thrombin Inhibitor |
| MeSH PA | D000925 | Anticoagulants |
| MeSH PA | D000991 | Antithrombins |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D006401 | Hematologic Agents |
| MeSH PA | D011480 | Protease Inhibitors |
| MeSH PA | D015842 | Serine Proteinase Inhibitors |
| FDA EPC | N0000175980 | Anti-coagulant |
| CHEBI has role | CHEBI:35554 | cardiovascular drug |
| CHEBI has role | CHEBI:50249 | anticoagulant |
| CHEBI has role | CHEBI:65232 | EC 3.4.21.5 (thrombin) inhibitor |
Related Drugs by ATC class:
B01AE Direct thrombin inhibitors 5 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Percutaneous coronary intervention | indication | 415070008 | |
| Unstable Angina Pectoris during PTCA | indication | ||
| Acute coronary syndrome | off-label use | 394659003 | |
| Intracranial hemorrhage | contraindication | 1386000 | |
| Bleeding | contraindication | 131148009 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 3.06 | acidic |
| pKa2 | 3.51 | acidic |
| pKa3 | 3.89 | acidic |
| pKa4 | 4.04 | acidic |
| pKa5 | 4.21 | acidic |
| pKa6 | 4.49 | acidic |
| pKa7 | 9.65 | acidic |
| pKa8 | 11.93 | acidic |
| pKa9 | 12.59 | acidic |
| pKa10 | 12.84 | acidic |
| pKa11 | 13.06 | acidic |
| pKa12 | 13.08 | acidic |
| pKa13 | 13.4 | acidic |
| pKa14 | 13.64 | acidic |
| pKa15 | 13.69 | acidic |
| pKa16 | 13.81 | acidic |
| pKa17 | 13.99 | acidic |
| pKa18 | 10.75 | Basic |
| pKa19 | 8.16 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 250MG/50ML (5MG/ML) | ANGIOMAX RTU | MAIA PHARMS INC | N211215 | July 25, 2019 | RX | SOLUTION | INTRAVENOUS | 11903993 | May 20, 2039 | USE AS AN ANTICOAGULANT IN PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION (PCI) |
| 250MG/50ML (5MG/ML) | ANGIOMAX RTU | MAIA PHARMS INC | N211215 | July 25, 2019 | RX | SOLUTION | INTRAVENOUS | 11918622 | May 20, 2039 | USE AS AN ANTICOAGULANT IN PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION (PCI) |
| 250MG/50ML (5MG/ML) | ANGIOMAX RTU | MAIA PHARMS INC | N211215 | July 25, 2019 | RX | SOLUTION | INTRAVENOUS | 12472224 | May 20, 2039 | USE AS AN ANTICOAGULANT IN PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION (PCI) |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Prothrombin | Enzyme | INHIBITOR | Ki | 8.60 | IUPHAR | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4021268 | VUID |
| N0000148708 | NUI |
| D03136 | KEGG_DRUG |
| 285044 | RXNORM |
| C0168273 | UMLSCUI |
| CHEBI:59173 | CHEBI |
| CHEMBL5314348 | ChEMBL_ID |
| CHEMBL5314353 | ChEMBL_ID |
| DB00006 | DRUGBANK_ID |
| C074619 | MESH_SUPPLEMENTAL_RECORD_UI |
| 6470 | IUPHAR_LIGAND_ID |
| 7282 | INN_ID |
| TN9BEX005G | UNII |
| 16129704 | PUBCHEM_CID |
| 15879 | MMSL |
| 234768 | MMSL |
| 41019 | MMSL |
| d04744 | MMSL |
| 129498009 | SNOMEDCT_US |
| 400610005 | SNOMEDCT_US |
| 4021268 | VANDF |
| 009031 | NDDF |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| bivalirudin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-3158 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 250 mg | INTRAVENOUS | NDA authorized generic | 25 sections |
| Bivalirudin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-275 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 250 mg | INTRAVENOUS | ANDA | 25 sections |
| Bivalirudin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42023-622 | INJECTION, SOLUTION | 250 mg | INTRAVENOUS | NDA | 25 sections |
| Bivalirudin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52958-034 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 250 mg | INTRAVENOUS | ANDA | 23 sections |
| Bivalirudin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55111-652 | INJECTION | 250 mg | INTRACAVERNOUS | ANDA | 25 sections |
| BIVALIRUDIN | Human Prescription Drug Label | 1 | 55150-210 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 250 mg | INTRAVENOUS | ANDA | 25 sections |
| Bivalirudin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63323-562 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 250 mg | INTRAVENOUS | ANDA | 27 sections |
| Bivalirudin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63323-562 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 250 mg | INTRAVENOUS | ANDA | 27 sections |
| Bivalirudin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67457-256 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 250 mg | INTRAVENOUS | ANDA | 26 sections |
| bivalirudin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70436-025 | INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION | 250 mg | INTRAVENOUS | ANDA | 26 sections |
| Bivalirudin | Human Prescription Drug Label | 1 | 70511-142 | INJECTION, SOLUTION | 250 mg | INTRAVENOUS | NDA | 25 sections |
| BIVALIRUDIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71288-427 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 250 mg | INTRAVENOUS | ANDA | 26 sections |
| BIVALIRUDIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71288-427 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 250 mg | INTRAVENOUS | ANDA | 26 sections |
| bivalirudin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72572-035 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 250 mg | INTRAVENOUS | NDA authorized generic | 25 sections |
| Bivalirudin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 83634-400 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 250 mg | INTRAVENOUS | ANDA | 26 sections |