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Factor Concentrate (Bebulin)
Bebulin is a prothrombin complex concentrate that replaces deficient vitamin K-dependent clotting factors (II, VII, IX, X) to restore hemostatic function.
Bebulin is a prothrombin complex concentrate that replaces deficient vitamin K-dependent clotting factors (II, VII, IX, X) to restore hemostatic function. Used for Warfarin reversal in patients with serious bleeding, Coagulopathy due to vitamin K deficiency, Coagulopathy associated with liver disease.
At a glance
| Generic name | Factor Concentrate (Bebulin) |
|---|---|
| Also known as | Bebulin |
| Sponsor | The University of Texas Health Science Center, Houston |
| Drug class | Prothrombin complex concentrate (PCC) |
| Target | Coagulation factors II, VII, IX, X |
| Modality | Biologic |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
Mechanism of action
Bebulin contains lyophilized concentrates of the vitamin K-dependent coagulation factors II, VII, IX, and X derived from human plasma. It is used to rapidly correct coagulopathy and restore clotting capacity in patients with deficiencies of these factors, such as those with warfarin overdose, liver disease, or vitamin K deficiency. The concentrate works by directly supplying the missing clotting factors needed for the intrinsic and common coagulation pathways.
Approved indications
- Warfarin reversal in patients with serious bleeding
- Coagulopathy due to vitamin K deficiency
- Coagulopathy associated with liver disease
- Urgent reversal of anticoagulation
Common side effects
- Thromboembolism
- Disseminated intravascular coagulation (DIC)
- Hypersensitivity reactions
- Fever
- Headache
Key clinical trials
- Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB) (PHASE3)
- A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia (PHASE3)
- Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study ) (PHASE3)
- Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery (PHASE4)
- Treatment of Hemophilia A Patients With FVIII Inhibitors
- A Study to Assess the Reversal of the Anticoagulant Effects of Milvexian by 4-Factor Prothrombin Complex Concentrate (4F-PCC) (Part 1) and Recombinant Human Factor VIIa (rFVIIa) (Part 2) in Healthy Participants (PHASE1)
- Fibrinogen Concentrates Versus Cryoprecipitate in Liver Transplant Surgery (PHASE4)
- Administration of Prothrombin Complex Concentrate vs. Standard Transfusion During/After Heart Transplantation (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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