Anti-inhibitor Coagulant Complex

The mechanism of action of FEIBA is still the subject of scientific discussion. FEIBA contains multiple components, mainly non-activated factors II, IX, X and mainly activated factor VII.

• FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for: Control and prevention of bleeding episodes Perioperative management Routine prophylaxis to prevent or reduce the frequency of bleeding episodes. FEIBA is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor VIII or coagulation factor IX.

• Known anaphylactic or severe hypersensitivity reactions to FEIBA or any of its components, including factors of the kinin generating system. Disseminated intravascular coagulation (DIC).contraindicated

For intravenous use after reconstitution only. For intravenous use after reconstitution only ( 2 ) Each vial of FEIBA contains the labeled amount of factor VIII inhibitor bypassing activity in units. ( 2.1 ) Type of Bleeding Dose (unit/kg) Frequency/Duration Control and Prevention of Bleeding 50 - 100 Determined by the type of bleeding episode Perioperative Management 50 - 100 Determined by the type of surgical intervention Routine Prophylaxis 85 Every other day Maximum injection or infusion rate must not exceed 10 units per kg of body weight per minute. ( 2.3 ) 2.1 Dose A guide for dosing FEIBA is provided in Table 1. Table 1: Dosing Guidelines Dose (unit/kg) Frequency of Doses (hours) Duration of Therapy Control and Prevention of Bleeding Joint Hemorrhage 50 – 100 12 Until pain and acute disabilities are improved. Mucous Membrane Bleeding 50 – 100 6 At least 1 day or until bleeding is resolved. Soft Tissue Hemorrhage (e.g., retroperitoneal bleeding) 100 12 Until resolution of bleed. Other Severe Hemorrhage (e.g., CNS bleeds) 100 6 – 12 Until resolution of bleed. Perioperative Management Preoperative 50 – 100 One time dose Immediately prior to surgery. Postoperative 50 – 100 6 – 12 Until resolution of bleed and healing are achieved. Routine Prophylaxis 85 Every other day Dosage and duration of treatment depend on the location and extent of bleeding, and the patient's clinical condition. Careful monitoring of replacement therapy is necessary in cases of major surgery or life-threatening bleeding episodes.

FEIBA can cause thromboembolic events following doses above 200 units per kg per day and in patients with thrombotic risk factors. Monitor patients receiving FEIBA for signs and symptoms of thromboembolic events. ( 5.1 ) Anaphylaxis and severe hypersensitivity reactions may occur. Should symptoms occur, discontinue treatment with FEIBA and administer appropriate treatment. ( 5.2 ) FEIBA is made from human plasma and may contain infectious agents, e.g., viruses, the variant Creutzfeldt-Jacob disease (vCJD) and theoretically, Creutzfeldt-Jacob disease (CJD) agent. ( 5.3 ) 5.1 Embolic and Thrombotic Events Thromboembolic events (including venous thrombosis, pulmonary embolism, myocardial infarction, and stroke) can occur with FEIBA, particularly following the administration of high doses (above 200 units per kg per day) and/or in patients with thrombotic risk factors [see Adverse Reactions (6) ] . Patients with DIC, advanced atherosclerotic disease, crush injury, septicemia, or concomitant treatment with recombinant factor VIIa have an increased risk of developing thrombotic events due to circulating tissue factor or predisposing coagulopathy. Potential benefit of treatment with FEIBA should be weighed against the potential risk of these thromboembolic events. Monitor patients receiving more than 100 units per kg of body weight of FEIBA for the development of DIC, acute coronary ischemia and signs and symptoms of other thromboembolic events.

The most frequently reported adverse reactions observed in >5% of subjects in the prophylaxis trial were anemia, diarrhea, hemarthrosis, hepatitis B surface antibody positive, nausea, and vomiting. The serious adverse reactions seen with FEIBA are hypersensitivity reactions and thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis. The most common adverse reactions observed in >5% of subjects were anemia, diarrhea, hemarthrosis, hepatitis B surface antibody positive, nausea, and vomiting. ( 6.1 ) The serious adverse drug reactions are hypersensitivity and thromboembolic events, including stroke, pulmonary embolism, and deep vein thrombosis. ( 5.1 , 5.2 , 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals U.S.A., Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety assessment of FEIBA is based on the review of the data from two prospective clinical trials in which FEIBA was used for the treatment of acute bleeding episodes and a prospective trial that compared the use of FEIBA prophylactically versus on-demand treatment.

8.1 Pregnancy Risk Summary There are no data with FEIBA use in pregnant women to inform a drug-associated risk. There are no adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted with FEIBA. It is also not known whether FEIBA can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. In the U.S. general population, the estimated background risk for major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. There is no information available on the effect of FEIBA on labor and delivery. 8.2 Lactation Risk Summary There is no information regarding the presence of FEIBA in human milk, the effect on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for FEIBA and any potential adverse effects on the breastfed child from FEIBA or from the underlying condition. 8.4 Pediatric Use Safety and efficacy of FEIBA have been evaluated in nine pediatric subjects treated in the routine prophylaxis trial including 4 subjects ≥7 to <12 years of age and 5 subjects ≥12 to <16 years of age. The dosing for all pediatric subjects was based on body weight.

Metabolism

FEIBA is composed of different coagulation factors, with varying half-lives for the individual components. The pharmacokinetic properties of FEIBA have not been formally studied in humans.

1. 1Haemorrhage28326%
2. 2Treatment Failure13212%
3. 3Drug Ineffective928.4%
4. 4Haemarthrosis656.0%
5. 5Factor Viii Inhibition393.6%
6. 6Off Label Use373.4%
7. 7Death322.9%
8. 8Joint Swelling322.9%
9. 9Therapy Partial Responder322.9%
10. 10Haematoma302.8%
11. 11Anti Factor Viii Antibody Positive292.7%
12. 12Fall292.7%
13. 13Arthralgia282.6%
14. 14Pain282.6%
15. 15Muscle Haemorrhage242.2%

The 10 most recently updated of 19 ClinicalTrials.gov registrations naming Anti-inhibitor Coagulant Complex as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis
  Recruiting · Phase 3 · Interventional · 5 enrolled · Emory University
  NCT04563520updated 2026-04-29
• Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery
  Recruiting · Phase 2 · Interventional · 140 enrolled · Northwell Health
  NCT07032792updated 2026-03-11
• A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia
  Active not recruiting · Phase 3 · Interventional · 91 enrolled · Sanofi
  NCT05662319updated 2026-02-04
• Treatment of Hemophilia A Patients With FVIII Inhibitors
  Recruiting · Observational · 120 enrolled · Emory University
  NCT04023019updated 2025-09-05
• Real-life Clinical FEIBA Samples Measured Using the Version A of the HemA EnzySystem
  Completed · Observational · 6 enrolled · Enzyre B.V.
  NCT06357572updated 2024-04-10
• FEIBA Reconstitution Volume Reduction and Faster Infusion Study (FEIBA STAR)
  Completed · Phase 3 · Interventional · 45 enrolled · Baxalta now part of Shire
  NCT02764489updated 2023-02-14
• FEIBA to Optimize Postcardiopulmonary Bypass Hemostasis in Pediatric Cardiac Patients
  Withdrawn · Phase 2 · Interventional · 0 enrolled · Mayo Clinic
  NCT05020483updated 2022-12-05
• A Study to Evaluate the Safest Dose Range for FEIBA in Hemophilia A Patients With Inhibitors on Emicizumab
  Active not recruiting · Phase 4 · Interventional · 20 enrolled · Children's Hospital Los Angeles
  NCT04205175updated 2022-03-09
• A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants With Inhibitors
  Completed · Phase 3 · Interventional · 113 enrolled · Hoffmann-La Roche
  NCT02622321updated 2021-06-24
• Efficacy and Safety Study of Prophylactic Versus On-Demand Treatment With Feiba NF in Subjects With Hemophilia A or B and a High Titer Inhibitor
  Completed · Phase 3 · Interventional · 52 enrolled · Baxalta now part of Shire
  NCT00851721updated 2021-05-19

Frequently asked questions

How does Anti-inhibitor Coagulant Complex work?

The mechanism of action of FEIBA is still the subject of scientific discussion. FEIBA contains multiple components, mainly non-activated factors II, IX, X and mainly activated factor VII.

What is Anti-inhibitor Coagulant Complex used for?

According to FDA labeling, Anti-inhibitor Coagulant Complex carries indications including: FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for: Control and prevention of bleeding episodes Perioperative management Routine prophylaxis to prevent or reduce the frequency of bleeding episodes. FEIBA is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor VIII or coagulation factor IX.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Anti-inhibitor Coagulant Complex?

Anti-inhibitor Coagulant Complex is classified as Blood coagulation factors, Anti-inhibitor Coagulant Complex, Enzyme Activators, Increased Coagulation Activity, Increased Coagulation Factor Concentration, Reversed Anticoagulation Activity.

What are the brand names for Anti-inhibitor Coagulant Complex?

Anti-inhibitor Coagulant Complex is marketed under brand names including Feiba.

What are the contraindications for Anti-inhibitor Coagulant Complex?

Anti-inhibitor Coagulant Complex labeling lists contraindications including: Known anaphylactic or severe hypersensitivity reactions to FEIBA or any of its components, including factors of the kinin generating system. Disseminated intravascular coagulation (DIC).. Always consult the full prescribing information and a clinician.