Menu

Efficacy Data

FEIBA prophylaxis delivered a reduction in median Annual Bleed Rate (ABR) compared with on-demand treatment1

ABR in on-demand vs prophylactic treatment1
FEIBA prophylaxis delivered a reduction in median Annual Bleed Rate (ABR) compared with on-demand treatment

PROOF Study: a phase 3, prospective, randomized, 12-month, open-label study in 36 patients with hemophilia A or B and with inhibitors. Seventeen patients received FEIBA [Anti-Inhibitor Coagulant Complex] prophylactically (85 ± 15 U/kg every other day), while 19 patients received FEIBA on-demand for the resolution of acute bleeding episodes (dosages determined by treating physicians).3

Of those patients who achieved zero bleeding events, 2 out of 3, completed the study.3

FEIBA prophylaxis delivered a reduction in joint bleeds compared with on-demand treatment3

Joint bleeds, on-demand vs prophylactic treatment3
FEIBA prophylaxis delivered a reduction in joint bleeds compared with on-demand treatment

PROOF Study: a phase 3, prospective, randomized, 12-month, open-label study in 36 hemophilia A or B patients with inhibitors. Seventeen patients received FEIBA prophylactically (85 ± 15 U/kg every other day), while 19 patients received FEIBA on-demand for the resolution of acute bleeding episodes (dosages determined by treating physicians).3

*Seven new target joints in 5 subjects treated with prophylaxis compared with 23 new target joints in 11 subjects in the on-demand arm.1,† Not significant

Target joint = Ankle, knee, elbow, or hip joint in which ≥4 bleeding episodes occurred in the same joint within a 6-month period during the study and was not a target joint at study initiation.

Selected Important Risk Information for FEIBA [Anti-Inhibitor Coagulant Complex]

WARNING: EMBOLIC AND THROMBOTIC EVENTS

  • Thromboembolic events have been reported during post-marketing surveillance following infusion of FEIBA, particularly following the administration of high doses (above 200 units per kg per day) and/or in patients with thrombotic risk factors.
  • Monitor patients receiving FEIBA for signs and symptoms of thromboembolic events.

CONTRAINDICATIONS

FEIBA is contraindicated in patients with:

  • History of anaphylactic or severe hypersensitivity reactions to FEIBA or any of its components, including factors of the kinin generating system
  • Disseminated intravascular coagulation (DIC)
  • Acute thrombosis or embolism (including myocardial infarction)

WARNINGS AND PRECAUTIONS

Thromboembolic events (including venous thrombosis, pulmonary embolism, myocardial infarction, and stroke) can occur, particularly following the administration of high doses (>200 units/kg/day) and/or in patients with thrombotic risk factors.

Offer your patients the opportunity to control unexpected bleeds1

FEIBA was used to treat 165 bleeding episodes1,*
Offer your patients the opportunity to control unexpected bleeds Offer your patients the opportunity to control unexpected bleeds

*Dose dependent on the location and extent of bleeding and the patient's clinical condition.

A multicenter, randomized, prospective trial was conducted in 44 hemophilia A subjects with inhibitors, 3 hemophilia B subjects with inhibitors, and 2 acquired factor VIII inhibitor subjects. The trial was designed to evaluate the efficacy of FEIBA in the treatment of joint, mucous membrane, musculocutaneous, and emergency bleeding episodes such as central nervous system hemorrhages and surgical bleedings.

With a high bleed-control efficacy rate, FEIBA allows you to manage your patients’ bleeds.

FEIBA was rated effective during surgical procedures5

Overall hemostatic efficacy of FEIBA5
Overall hemostatic efficacy of FEIBA in surgical patients
Intraoperative hemostatic efficacy of FEIBA5
Intraoperative hemostatic efficacy of FEIBA

In the SURF study, hemostatic efficacy was defined as follows: Excellent = hemostatic expectations were met or exceeded in light of previous experience with bypassing agents. Good = efficacy was “somewhat less than expected” but still adequate compared with previous bypassing therapy. Fair = hemostasis was significantly less than expected compared with previous bypassing therapy.

As with all plasma-derived products, the risk of transmission of infectious agents cannot be totally eliminated. To date, reports from self-reported databases show there have been no confirmed reports of transmission of hepatitis A, B, or C or human immunodeficiency virus (HIV) associated with the use of FEIBA since the introduction of vapor heat treatment. Ongoing surveillance indicates that this remains valid.4, 7, 8

Overall efficacy was rated as excellent or good for 91% of surgical procedures (n=34)5
Intraoperative efficacy was rated as excellent or good for 94% of surgical procedures (n=34)5

There were 2 adverse events (AEs) attributed to FEIBA5

  • Treatment–related, serious AE: 1 case of a clot in an arteriovenous fistula occurred during a moderate-risk surgery
  • Not treatment–related, serious AE: 1 case of anemia and 1 case of hemarthrosis; each occurred during severe-risk surgeries
  • Treatment–related, nonserious AE: 1 case of postoperative anemia

Selected Important Risk Information for FEIBA [Anti-Inhibitor Coagulant Complex]

WARNINGS AND PRECAUTIONS (continued)

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 should be weighed against potential risk of these thromboembolic events.

Infusion should not exceed a single dose of 100 units/kg and daily doses of 200 units/kg. Maximum injection or infusion rate must not exceed 2 units/kg/minute. Monitor patients receiving >100 units/kg for the development of DIC, acute coronary ischemia and signs and symptoms of other thromboembolic events. If clinical signs or symptoms occur, such as chest pain or pressure, shortness of breath, altered consciousness, vision, or speech, limb or abdomen swelling and/or pain, discontinue FEIBA and initiate appropriate diagnostic and therapeutic measures.

Safety and efficacy of FEIBA for breakthrough bleeding in patients receiving emicizumab has not been established. Cases of thrombotic microangiopathy (TMA) were reported in a clinical trial where subjects received FEIBA as part of a treatment regimen for breakthrough bleeding following emicizumab treatment. Consider the benefits and risks with FEIBA if considered required for patients receiving emicizumab prophylaxis. If treatment with FEIBA is required for patients receiving emicizumab, the hemophilia treating physician should closely monitor for signs and symptoms of TMA. In FEIBA clinical studies TMA has not been reported.

Dosing Guidelines

The FEIBA Guidelines for Dosing is an educational guide for healthcare professionals only.

Learn More

Mechanism of Action

Multiple clotting factors of FEIBA achieve hemostasis in an in vitro analysis.2

See How It Works
See LessMore

Indications for Feiba

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

Detailed Important Risk Information

WARNING: THROMBOEMBOLIC EVENTS

  • Thromboembolic events have been reported during post-marketing surveillance following infusion of FEIBA,

Indications for Feiba

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...

Detailed Important Risk Information

WARNING: EMBOLIC AND THROMBOTIC EVENTS

  • Thromboembolic events have been reported during post-marketing surveillance following infusion of FEIBA, particularly following the administration of high doses (above 200 units per kg per day) and/or in patients with thrombotic risk factors.
  • Monitor patients receiving FEIBA for signs and symptoms of thromboembolic events.
;

FEIBA [Anti-Inhibitor Coagulant Complex] Indications and Detailed Important Risk Information

Indications for FEIBA

FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for:


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.

Detailed Important Risk Information for FEIBA

WARNING: EMBOLIC AND THROMBOTIC EVENTS

  • Thromboembolic events have been reported during post-marketing surveillance following infusion of FEIBA, particularly following the administration of high doses (above 200 units per kg per day) and/or in patients with thrombotic risk factors.
  • Monitor patients receiving FEIBA for signs and symptoms of thromboembolic events.

CONTRAINDICATIONS

FEIBA is contraindicated in patients with:

WARNINGS AND PRECAUTIONS

Thromboembolic events (including venous thrombosis, pulmonary embolism, myocardial infarction, and stroke) can occur, particularly following the administration of high doses (>200 units/kg/day) and/or in patients with thrombotic risk factors.

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 should be weighed against the potential risk of these thromboembolic events.

Infusion should not exceed a single dose of 100 units/kg and daily doses of 200 units/kg. Maximum injection or infusion rate must not exceed 2 units/kg/minute. Monitor patients receiving >100 units/kg for the development of DIC, acute coronary ischemia and signs and symptoms of other thromboembolic events. If clinical signs or symptoms occur, such as chest pain or pressure, shortness of breath, altered consciousness, vision, or speech, limb or abdomen swelling and/or pain, discontinue FEIBA and initiate appropriate diagnostic and therapeutic measures.

Safety and efficacy of FEIBA for breakthrough bleeding in patients receiving emicizumab has not been established. Cases of thrombotic microangiopathy (TMA) were reported in a clinical trial where subjects received FEIBA as part of a treatment regimen for breakthrough bleeding following emicizumab treatment. Consider the benefits and risks with FEIBA if considered required for patients receiving emicizumab prophylaxis. If treatment with FEIBA is required for patients receiving emicizumab, the hemophilia treating physician should closely monitor for signs and symptoms of TMA. In FEIBA clinical studies TMA has not been reported.

Hypersensitivity and allergic reactions, including severe anaphylactoid reactions, can occur. Symptoms include urticaria, angioedema, gastrointestinal manifestations, bronchospasm, and hypotension. Reactions can be severe and systemic (e.g., anaphylaxis with urticaria and angioedema, bronchospasm, and circulatory shock). Other infusion reactions, such as chills, pyrexia, and hypertension have also been reported. If signs and symptoms of severe allergic reactions occur, immediately discontinue FEIBA and provide appropriate supportive care.

Because FEIBA is made from human plasma it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

FEIBA contains blood group isohemagglutinins (anti-A and anti-B). Passive transmission of antibodies to erythrocyte antigens, e.g., A, B, D, may interfere with some serological tests for red cell antibodies, such as antiglobulin test (Coombs test).

ADVERSE REACTIONS

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.

Serious adverse reactions seen are hypersensitivity reactions and thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis.

DRUG INTERACTIONS

Consider possibility of thrombotic events when systemic antifibrinolytics such as tranexamic acid and aminocaproic acid are used with FEIBA. No adequate and well-controlled studies of combined or sequential use of FEIBA and recombinant factor VIIa, antifibrinolytics, or emicizumab, have been conducted. Use of antifibrinolytics within approximately 6 to 12 hours after FEIBA is not recommended.

Clinical experience from an emicizumab clinical trial suggests that a potential drug interaction may exist with emicizumab.

Please see FEIBA full Prescribing Information, including BOXED WARNING on Embolic and Thrombotic Events