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Administration

Loren, Actual FEIBA Patient

Help your patients utilize their time while infusing

Infusing FEIBA [Anti-Inhibitor Coagulant Complex] with a syringe pump helps your patients control the infusion rate and provides a hands-free experience.1

Maximum injection or infusion rate must not exceed 2 units per kg of body weight per minute.

FEIBA is available in 3 dosage strengths1,*

Color-coded boxes and vial labels make it easy to identify each dose level.

FEIBA comes with a suitable volume (10 mL, 20 mL, or 50 mL) of Sterile Water for Injection.

My syringe pump allows me to continue doing the things I like to do while I infuse, like gaming and tinkering. I also like to do card tricks—which are hard to do one-handed. —Loren, real FEIBA patient

Room temperature storage1

  • Store at room temperature. Do not exceed 25°C (77°F)
  • Store FEIBA [Anti-Inhibitor Coagulant Complex] in its original package to protect it from light
  • Avoid freezing, which may damage the diluent vial

BAXJECT® II Hi-Flow Needleless Transfer Device for easy mixing

To make reconstitution safe, fast, and easy,* FEIBA comes packaged with the BAXJECT II Hi-Flow Needleless Transfer Device. Reconstitution with the BAXJECT II Hi-Flow device requires fewer steps than the previous BAXJECT device, and it is color-coded for more intuitive reconstitution.1,4

  1. Connect the diluent vial
  2. Connect the FEIBA vial
  3. Withdraw mixed FEIBA
*As compared to needles, the BAXJECT II Hi-Flow device is needleless and has a one-piece design.

Watch the Reconstitution Demonstration Video with BAXJECT II Hi-Flow Device

For detailed step-by-step instructions for reconstituting FEIBA with BAXJECT II Hi-Flow device, watch the video below or download the Instructions for Use.

Watch the Reconstitution Troubleshooting Video with BAXJECT II Hi-Flow Device

For additional information and troubleshooting guidance for reconstituting FEIBA with BAXJECT II Hi-Flow device, watch the video below.


BAXJECT II Hi-Flow Product Information

Rx only. For safe and proper use of this device, please refer to the Instructions for Use in the FEIBA full Prescribing Information.

NOTE: The BAXJECT II Hi-Flow device should be used only with FEIBA.

The BAXJECT II Hi-flow device is intended for use with a single vial of product and is for single use only. Therefore, reconstitution and withdrawing a second vial into the syringe requires a second BAXJECT II Hi-flow device.

Dosing Guidelines

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

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Efficacy Data

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

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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.
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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