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Intended for US HCPs Only

Dosing Guidelines

Loren, Actual FEIBA Patient

Every-other-day dosing for patients on the go

Routine prophylaxis: 85 U/kg every other day1
FEIBA [Anti-Inhibitor Coagulant Complex] is the only FDA-approved, prophylactic treatment for people with hemophilia A and B with inhibitors1

FEIBA Guidelines for Dosing

Patients with inhibitors present a difficult clinical challenge. Bypassing agents, such as FEIBA, play an important role in the management of inhibitors.1,15,16

Use this guide to help when determining the appropriate dose for your patients based on weight, dosing schedule and type of bleeding episode.

1. Select your patient’s body weight

Select
  • 22 lb (10 kg)
  • 33 lb (15 kg)
  • 44 lb (20 kg)
  • 55 lb (25 kg)
  • 66 lb (30 kg)
  • 77 lb (35 kg)
  • 88 lb (40 kg)
  • 99 lb (45 kg)
  • 110 lb (50 kg)
  • 121 lb (55 kg)
  • 132 lb (60 kg)
  • 143 lb (65 kg)
  • 154 lb (70 kg)
  • 165 lb (75 kg)
  • 176 lb (80 kg)
  • 187 lb (85 kg)
  • 198 lb (90 kg)
  • 209 lb (95 kg)
  • 220 lb (100 kg)
  • 231 lb (105 kg)
  • 242 lb (110 kg)
  • 253 lb (115 kg)
  • 264 lb (120 kg)
  • 275 lb (125 kg)
  • 286 lb (130 kg)
  • 297 lb (135 kg)
  • 308 lb (140 kg)

2. Select dosing schedule

  • Routine prophylaxis
  • Control and prevention
  • Perioperative management

3. Select type of bleeding episode

  • Preoperative
  • Postoperative
  • Joint hemorrhage
  • Mucous membrane bleeding
  • Soft tissue hemorrhage (e.g., retroperitoneal bleeding)
  • Other severe hemorrhage (e.g., CNS bleeds)

Dose range: 50 U/2.2 lb (50 U/kg) - 100 U/2.2 lb (100 U/kg)

Total FEIBA units range: to

Dose: 85 U/2.2 lb (85 U/kg)

Total FEIBA units:

Frequency of doses (hours): 6

Duration of therapy: At least 1 day or until bleeding is resolved

Do not exceed a single dose of 100 units per kg body weight and a daily dose of 200 units per kg body weight.1

Healthcare professionals are ultimately responsible to determine the appropriate dose for each patient based on patient examination, characteristics, and medical judgment.

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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 of life-threatening bleeding episodes.1

Base the dose and frequency of FEIBA on the individual clinical response. Clinical response to treatment with FEIBA may vary by patient, and may not correlate with the patient’s inhibitor titer.1

Do not exceed a single dose of 100 units per kg body weight and a daily dose of 200 units per kg body weight.1

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.

Administration

Get information about the BAXJECT® II Hi-Flow Needleless Transfer Device and available dosage strengths.

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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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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