Anti-inhibitor coagulant complex

Overview

Anti-inhibitor coagulant complex, also known as FEIBA (factor eight inhibitor bypassing activity), contains several proteins involved in the prothrombinase complex. It is used to control bleeding in hemophilia A and B patients with inhibitors.

Indication

For use in the control of bleeding episodes, perioperative management, and routine prophylaxis against bleeding episodes in hemophilia A and B patients with inhibitors. It is not indicated in the absence of factor VIII or IX inhibitors.

Associated Conditions

Bleeding caused by Hemophilia A
Bleeding caused by Hemophilia B
Perioperative bleeding caused by Hemophilia A
Perioperative bleeding caused by Hemophilia B

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery	2025/06/24	NCT07032792	Phase 2	Not yet recruiting	Northwell Health
An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment	2025/03/19	NCT06883240	N/A	Recruiting	Hoffmann-La Roche
FEIBA to Optimize Postcardiopulmonary Bypass Hemostasis in Pediatric Cardiac Patients	2021/08/25	NCT05020483	Phase 2	Withdrawn	Mayo Clinic
SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis	2020/09/24	NCT04563520	Phase 3	Recruiting	Emory University
A Study to Evaluate the Safest Dose Range for FEIBA in Hemophilia A Patients With Inhibitors on Emicizumab	2019/12/19	NCT04205175	Phase 4	Active, not recruiting	Children's Hospital Los Angeles
FEIBA and Use of Blood Products in Cardiac Surgery	2015/10/16	NCT02577614	Phase 1	Completed	Oregon Health and Science University
Observational Patient Diary Study of Treatment Doses for Patients With Haemophilia With Inhibitors to Factors VIII and IX	2008/07/04	NCT00710619	N/A	Completed	Novo Nordisk A/S
The FEIBA NovoSeven Comparative Study	2005/09/14	NCT00166309	Not Applicable	Completed	Skane University Hospital
Trial of NovoSeven® in Haemophilia - Joint Bleeds	2005/04/19	NCT00108797	Phase 4	Completed	Novo Nordisk A/S

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
FEIBA 1000 U	Takeda Manufacturing Austria AG, Siegfried Hameln GmbH (Solvent)	SIN10886P	INJECTION, POWDER, FOR SOLUTION	50 u/ml	4/20/1999
FEIBA 500 U	Takeda Manufacturing Austria AG, Siegfried Hameln GmbH (Solvent)	SIN10889P	INJECTION, POWDER, FOR SOLUTION	25 u/ml	4/20/1999

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

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
FEIBA-NF factor VIII inhibitor bypassing fraction 2500U powder for injection vial with diluent vial	172236	Takeda Pharmaceuticals Australia Pty Ltd	Medicine	A	3/30/2012
FEIBA-NF factor eight inhibitor bypassing fraction 1000U powder for injection vial with diluent vial	104911	Takeda Pharmaceuticals Australia Pty Ltd	Medicine	A	1/9/2007
FEIBA-NF factor eight inhibitor bypassing fraction 500U powder for injection vial with diluent vial	104896	Takeda Pharmaceuticals Australia Pty Ltd	Medicine	A	1/9/2007

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
FEIBA NF	takeda canada inc	02480549	Powder For Solution , Kit - Intravenous	650 UNIT / VIAL	N/A
FEIBA NF	takeda canada inc	02353903	Kit , Powder For Solution - Intravenous	3250 UNIT / VIAL	4/4/2011
FEIBA NF	takeda canada inc	02489600	Powder For Solution , Kit - Intravenous	650 UNIT / VIAL	N/A
FEIBA NF	takeda canada inc	02202581	Powder For Solution , Kit - Intravenous	1300 UNIT / VIAL	10/27/1997

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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