Overview
Aprotinin is a protein-based drug that is also known as bovine pancreatic trypsin inhibitor (BPTI). Since it demonstrates the capacity to slow fibrinolysis, it has been employed to reduce bleeding during complex surgery such as heart and liver surgery. For this use, it is typically administered by injection. The goal of using of aprotinin was subsequently to minimize end-organ damage resulting from hypotension due to blood loss in surgery and to reduce the necessity for blood transfusions during surgery. Nevertheless, the drug was formally withdrawn worldwide in May of 2008 after studies confirmed that its use enhanced the risk of complications or death. The substance is consequently made available only for very restricted research use.
Background
Aprotinin is a protein-based drug that is also known as bovine pancreatic trypsin inhibitor (BPTI). Since it demonstrates the capacity to slow fibrinolysis, it has been employed to reduce bleeding during complex surgery such as heart and liver surgery. For this use, it is typically administered by injection. The goal of using of aprotinin was subsequently to minimize end-organ damage resulting from hypotension due to blood loss in surgery and to reduce the necessity for blood transfusions during surgery. Nevertheless, the drug was formally withdrawn worldwide in May of 2008 after studies confirmed that its use enhanced the risk of complications or death. The substance is consequently made available only for very restricted research use.
Indication
For prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at an increased risk for blood loss and blood transfusion.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/08/26 | Not Applicable | UNKNOWN | |||
2008/04/28 | Phase 3 | Completed | |||
2008/02/18 | N/A | Completed | State University of New York - Upstate Medical University | ||
2008/02/11 | N/A | NO_LONGER_AVAILABLE | |||
2006/11/07 | Phase 3 | UNKNOWN | German Heart Center | ||
2006/11/02 | Not Applicable | UNKNOWN | |||
2006/07/28 | Phase 1 | Completed | |||
2006/07/20 | Phase 1 | Terminated | |||
2006/05/18 | Phase 3 | Terminated | |||
2006/03/23 | Phase 3 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| TRASYLOL INJECTION 500,000 kiu/50 ml | SIN07805P | INJECTION | 500000 kiu/50 ml | 7/26/1994 | |
| TISSEEL FIBRIN SEALANT VH S/D (FROZEN) | SIN14707P | SOLUTION | 2250-3750 KIU/ml | 12/22/2014 | |
| ARTISS SOLUTIONS FOR SEALANT, DEEP FROZEN | SIN14719P | SOLUTION | 2250 – 3750 KIU/ml | 1/6/2015 | |
| BERIPLAST P COMBI-SET 3ML POWDERS AND SOLVENTS FOR SEALANT | SIN16776P | OTHER | 3000KIU | 5/10/2023 | |
| BERIPLAST P COMBI-SET 1ML POWDERS AND SOLVENTS FOR SEALANT | SIN16775P | OTHER | 1000KIU | 5/10/2023 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Aprotinin and Sodium Chloride Injection | 国药准字H20030385 | 化学药品 | 注射剂 | 5/25/2022 | |
| Aprotinin and Sodium Chloride Injection | 国药准字H20030384 | 化学药品 | 注射剂 | 5/25/2022 | |
| Aprotinin and Sodium Chloride Injection | 国药准字H20030383 | 化学药品 | 注射剂 | 5/25/2022 | |
| Aprotinin for Injection | 国药准字H22023733 | 化学药品 | 注射剂（冻干） | 10/9/2023 | |
| Aprotinin for Injection | 国药准字H33020570 | 化学药品 | 注射剂 | 5/22/2020 | |
| Aprotinin for Injection | 国药准字H20045233 | 化学药品 | 注射剂 | 3/1/2023 | |
| Aprotinin for Injection | 国药准字H44020648 | 化学药品 | 注射剂 | 9/8/2023 | |
| Aprotinin for Injection | 国药准字H62020022 | 化学药品 | 冻干粉针剂 | 5/25/2022 | |
| Aprotinin for Injection | 国药准字H62020023 | 化学药品 | 冻干粉针剂 | 5/25/2022 | |
| Aprotinin for Injection | 国药准字H22023734 | 化学药品 | 注射剂（冻干） | 10/9/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| TRASYLOL 2,000,000 KIU/200mL | 58867 | Link Medical Products Pty Ltd T/A Link Pharmaceuticals | Medicine | A | 6/3/1997 |
| ARTISS fibrin sealant VH S/D 4 IU (frozen) solution for sealant syringe | 163515 | Medicine | A | 8/19/2010 | |
| TISSEEL VH S/D fibrin sealant syringe | 147141 | Medicine | A | 3/13/2009 | |
| TRASYLOL 500,000KIU/50mL injection vial | 43530 | Link Medical Products Pty Ltd T/A Link Pharmaceuticals | Medicine | A | 8/2/1993 |
| TRASYLOL Aprotinin 1,000,000 KIU/100mL | 58869 | Link Medical Products Pty Ltd T/A Link Pharmaceuticals | Medicine | A | 6/3/1997 |