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Intended for US HCPs Only

Safety Data

Gerrod, Actual FEIBA Patient

The FEIBA process helps ensure patient safety from collection to final product1,6

  • Integrated, validated, 2-step virus inactivation and removal process
  • Plasma collected and tested by FDA-approved establishments and procedures

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 [Anti-Inhibitor Coagulant Complex] since the introduction of vapor heat treatment. Ongoing surveillance indicates that this remains valid.6

The FEIBA plasma screening and purification processes help to ensure purity and safety6

Plasma screening

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.

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.

Shire’s commitment to the hemophilia community

Yesterday, today, and tomorrow

FEIBA History
Baxter* acquires Hyland, a company that made human plasma commercially available7

*Part of Baxter’s BioScience business at the time. Baxalta Incorporated was launched in 2015 following separation from Baxter. The company combined with Shire plc in June 2016.

†No longer commercially available.
Baxter* introduced the first commercially available factor VIII concentrate to treat hemophilia8

*Part of Baxter’s BioScience business at the time. Baxalta Incorporated was launched in 2015 following separation from Baxter. The company combined with Shire plc in June 2016.

†No longer commercially available.
FEIBA [Anti-Inhibitor Coagulant Complex], the first activated prothrombin complex concentrate for people with hemophilia and inhibitors, is introduced by Baxter*4

*Part of Baxter’s BioScience business at the time. Baxalta Incorporated was launched in 2015 following separation from Baxter. The company combined with Shire plc in June 2016.

†No longer commercially available.
Baxter* introduced the first heat-treated factor VIII concentrate for hemophilia8

*Part of Baxter’s BioScience business at the time. Baxalta Incorporated was launched in 2015 following separation from Baxter. The company combined with Shire plc in June 2016.

†No longer commercially available.
FEIBA VH [Anti-inhibitor coagulant complex] is approved in U.S.9
†No longer commercially available.
Baxter* introduced the first US factor VIII purified by monoclonal techniques and chemically treated for viral inactivation.8
*Part of Baxter’s BioScience business at the time. Baxalta Incorporated was launched in 2015 following separation from Baxter. The company combined with Shire plc in June 2016.
Baxter* introduced the first recombinant factor VIII.8
*Part of Baxter’s BioScience business at the time. Baxalta Incorporated was launched in 2015 following separation from Baxter. The company combined with Shire plc in June 2016.
First third-generation recombinant factor VIII.10
Baxter* introduced the 2500-unit vial of FEIBA VH.4

*Part of Baxter’s BioScience business at the time. Baxalta Incorporated was launched in 2015 following separation from Baxter. The company combined with Shire plc in June 2016.

†No longer commercially available.
Baxter* launched FEIBA NF11

*Part of Baxter’s BioScience business at the time. Baxalta Incorporated was launched in 2015 following separation from Baxter. The company combined with Shire plc in June 2016.

†No longer commercially available.
Baxter* offers FEIBA that can be stored at room temperature for 24 months12
*Part of Baxter’s BioScience business at the time. Baxalta Incorporated was launched in 2015 following separation from Baxter. The company combined with Shire plc in June 2016.
FEIBA offers another option for treatment with routine prophylaxis11,13

Mechanism of Action

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

See How It Works

Efficacy Data

Find out how FEIBA can help your patients with hemophilia A and B with inhibitors.

See the Data

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 (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: THROMBOEMBOLIC EVENTS

CONTRAINDICATIONS

The use of FEIBA is contraindicated in patients with:

WARNINGS AND PRECAUTIONS

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. Thrombotic microangiopathy (TMA) has not been reported in FEIBA clinical studies. Cases of TMAs were reported in an emicizumab clinical trial where subjects received FEIBA as part of a treatment regimen for breakthrough bleeding. The safety and efficacy of FEIBA for breakthrough bleeding in patients receiving emicizumab has not been established. If treatment with FEIBA is considered required for patients receiving emicizumab, patients must be closely monitored by their physicians.

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.

Infusion of FEIBA should not exceed a single dose of 100 units per kg body weight 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.

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

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.

DRUG INTERACTIONS

Consider the possibility of thrombotic events when systemic antifibrinolytics such as tranexamic acid and aminocaproic acid are used during treatment with FEIBA. No adequate and well-controlled studies of the 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 the administration of 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 Thromboembolic Events.