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Intended for US HCPs Only

Efficacy Data

Gerrod, Actual FEIBA Patient

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

ABR in on-demand vs prophylactic treatment1

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 [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, two-thirds completed 12 months of the study.3

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

Joint bleeds, on-demand vs prophylactic treatment3

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).

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,NS

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

WARNING: THROMBOEMBOLIC EVENTS

  • Thromboembolic events have been reported during post-marketing surveillance following infusion of FEIBA, particularly following the administration of high doses and/or in patients with thrombotic risk factors.
  • Monitor patients receiving FEIBA for signs and symptoms of 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 the infusion and initiate appropriate diagnostic and therapeutic measures.

Hypersensitivity and allergic reactions, including severe anaphylactoid reactions, can occur following the infusion of FEIBA. The symptoms include urticaria, angioedema, gastrointestinal manifestations, bronchospasm, and hypotension. These 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 administration of FEIBA and provide appropriate supportive care.

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.

Offer your patients the opportunity to control unexpected bleeds1

FEIBA was used to treat 165 bleeding episodes1

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 FEIBA
Intraoperative hemostatic efficacy of FEIBA

The SURgical interventions with FEIBA (SURF) study was an open-label, prospective, postauthorization study, specifically designed to clinically evaluate the perioperative use of FEIBA and accumulate a database of experience with perioperative FEIBA treatment that can be used to identify best practices in the surgical hemostatic management of hemophilia patients with inhibitors. This noninterventional, observational cohort study evaluated outcomes for 35 surgical procedures in 24 patients.5

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

  • One nonserious AE—postoperative anemia
  • One serious AE—a clot in an arteriovenous fistula occurred during moderate-risk surgery

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

WARNING: THROMBOEMBOLIC EVENTS

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

Infusion of FEIBA should not exceed a dose of 100 units per kg body weight every 6 hours and daily doses of 200 units per kg body weight. Maximum injection or infusion rate must not exceed 2 units per kg of body weight per minute. 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. 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 the infusion and initiate appropriate diagnostic and therapeutic measures.

Use of antifibrinolytics within approximately 6 to 12 hours after the administration of FEIBA is not recommended.

Dosing Guidelines

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

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Mechanism of Action

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

See How It Works

Please expand for Indications and Detailed Important Risk Information

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

WARNING: THROMBOEMBOLIC EVENTS

Thromboembolic events have been reported during post-marketing surveillance following infusion of FEIBA, particularly following the administration of high doses 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 for Healthcare Professionals

Indications for FEIBA [Anti-Inhibitor Coagulant Complex]

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 [Anti-Inhibitor Coagulant Complex]

WARNING: THROMBOEMBOLIC EVENTS

The use of FEIBA is contraindicated in patients with:

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.

Infusion of FEIBA should not exceed a dose of 100 units per kg body weight every 6 hours and daily doses of 200 units per kg body weight. Maximum injection or infusion rate must not exceed 2 units per kg of body weight per minute. 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. 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 the infusion and initiate appropriate diagnostic and therapeutic measures.

Hypersensitivity and allergic reactions, including severe anaphylactoid reactions, can occur following the infusion of FEIBA. The symptoms include urticaria, angioedema, gastrointestinal manifestations, bronchospasm, and hypotension. These 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 administration of 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.

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.

Use of antifibrinolytics within approximately 6 to 12 hours after the administration of FEIBA is not recommended.

Please see FEIBA full Prescribing Information