• Bleeding disorders

Feiba Generic Name & Formulations

General Description

Anti-inhibitor Coagulant Complex (AICC) 500 units, 1000 units, 2500 units; per vial; lyophilized pwd for IV infusion after reconstitution; contains Factors II, IX, X (non-activated); Factor VII (activated); Factor VIII inhibitor bypassing activity; Prothrombin Complex Factors; heparin-free.

Pharmacological Class

Coagulation factor complex.

How Supplied

Single-dose vials—1 (w. diluent, transfer device)

How Supplied

Feiba is available in single-dose vials in the following nominal dosage strengths:

  • 500 Units (Factor VIII Potency Range: 350-650 Units per vial)
  • 1000 Units (Factor VIII Potency Range: 700-1300 Units per vial)
  • 2500 Units (Factor VIII Potency Range: 1750-3250 Units per vial)

Feiba is packaged with a suitable volume (10 mL, 20 mL or 50 mL) of Sterile Water for Injection, USP., one Baxject II Hi-Flow Needleless Transfer Device, and one Package Insert.


Store at 36° F to 77° F (2° C to 25° C).

Store in the original package in order to protect from light. 

Do not freeze. 

Prior to preparation and reconstitution, allow the vials of Feiba and Sterile Water for Injection (diluent) to reach room temperature, if refrigerated.

Generic Availability


Feiba Indications


To control and prevent bleeding episodes, perioperative management, or as routine prophylaxis to prevent or reduce the frequency of bleeding episodes in Hemophilia A and B with inhibitors (see full labeling). Not for treating bleeding episodes due to coagulation factor deficiencies in the absence of inhibitors to factor VIII or IX.

Feiba Dosage and Administration

Adults and Children

Infusion rate: ≤2units/kg/min. Joint hemorrhage: 50–100units/kg every 12hrs until improved. Mucous membrane bleeding: 50–100units/kg every 6hrs for at least 1 day or until resolved. Soft tissue hemorrhage: 100units/kg every 12hrs until resolved. Other severe hemorrhage (eg, CNS bleeds): 100units/kg every 6–12hrs until resolved. Preoperative: 50–100units/kg once immediately prior to surgery. Postoperative: 50–100units/kg every 6–12hrs until resolved and healed. Routine prophylaxis: 85units/kg every other day. All: Max 200units/kg per day (100units/kg per dose).

Feiba Contraindications


Hypersensitivity to factors of the kinin generating system. Disseminated intravascular coagulation (DIC). Acute thrombosis or embolism (including myocardial infarction).

Feiba Boxed Warnings

Boxed Warning

Embolic and thrombotic events.

Boxed Warning

Embolic and Thrombotic Events

  • Thromboembolic events have been reported during postmarketing 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 Warnings/Precautions


Increased risk of thromboembolic events esp. after high-doses (>200units/kg/day) and/or in patients with thrombotic risk factors (eg, DIC, atherosclerosis, crush injury, septicemia, concomitant recombinant factor VIIa). Monitor patients receiving doses >100units/kg for DIC development, acute coronary ischemia, and signs/symptoms of other thromboembolic events; discontinue if occurs and treat. Discontinue if hypersensitivity reactions occur. Contains human plasma; monitor for possible infection transmission. Elderly. Neonates. Pregnancy (Cat.C). Nursing mothers.


Embolic and Thrombotic Events

Thromboembolic events (including venous thrombosis, pulmonary embolism, myocardial infarction, and stroke) can occur with Feiba, 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 with Feiba should be weighed against the potential risk of these thromboembolic events. 

Monitor patients receiving >100 units/kg 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. 

The 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 treatment with emicizumab. 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 thrombotic microangiopathy (TMA) has not been reported. 

Hypersensitivity Reactions 

Hypersensitivity and allergic reactions, including severe anaphylactoid reactions, can occur following the infusion of Feiba. If signs and symptoms of severe allergic reactions occur, immediately discontinue administration of Feiba and provide appropriate supportive care. 

Transmission of Infectious Agents 

Because Feiba is made from human plasma it may carry a risk of transmitting infectious agents, eg, viruses, and the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The risk has been minimized by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections and by inactivating and removing certain viruses during the manufacturing process.

Pregnancy Considerations

There is no data with Feiba use in pregnant women to inform a drug-associated risk. There are no adequate and well-controlled studies in pregnant women. It is also not known whether Feiba can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.

There is no information available on the effect of Feiba on labor and delivery.

Nursing Mother Considerations

There is no information regarding the presence of Feiba in human milk, the effect on the breastfed child, or the effects on milk production. 

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Feiba and any potential adverse effects on the breastfed child from Feiba or from the underlying condition.

Pediatric Considerations

The safety and efficacy of Feiba has not been evaluated in neonates.

Geriatric Considerations

The safety and efficacy of Feiba has not been evaluated in subjects ≥65 years of age.

Feiba Pharmacokinetics

See Literature

Feiba Interactions


Separate systemic antifibrinolytics by 12hrs.


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 when Feiba was used as part of a treatment regimen for breakthrough bleeding.

Feiba Adverse Reactions

Adverse Reactions

Anemia, diarrhea, hemarthrosis, hep B surface antibody positive, nausea, vomiting; hypersensitivity, thromboembolic events (eg, stroke, DVT, PE).

Feiba Clinical Trials

Clinical Trials

Control and Prevention of Bleeding Episodes 

The efficacy of Feiba in the treatment of bleeding episodes has been demonstrated by 2 prospective clinical trials.

Trial 1 was a multicenter, randomized, double-blind trial comparing the effect of Feiba and a non-activated prothrombin complex concentrate in 15 patients with hemophilia A and inhibitors to factor VIII. A total of 150 bleeding episodes including 117 joints, 20 musculoskeletal and 4 mucocutaneous bleeds, were treated. A single dose of 88 units/kg was used uniformly for treatments with Feiba. A second treatment was allowed for muscle bleeds after 12 hours and 6 hours after mucocutaneous bleeds, if necessary. Patients and investigators were asked to rate hemostatic efficacy based on a scale of effective, partially effective, not effective or not sure. The criteria for evaluation of the effectiveness were severity of pain, subjective improvement, circumference of muscle or joint, restriction of joint mobility, cessation of open bleeding, start of rebleeding and quantity and nature of analgesics. Feiba was effective in 41% and partly effective in 25% of episodes (ie, combined effectiveness of 66%), while prothrombin complex concentrate was rated effective in 25% and partly effective in 21% of episodes (ie, combined effectiveness of 46%).

Trial 2 was a multicenter randomized, prospective trial. This trial was conducted in 44 hemophilia A patients with inhibitors, 3 hemophilia B patients with inhibitors, and 2 acquired factor VIII inhibitor patients. It 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. Forty-nine (49) patients with inhibitor titers of >5 BU were enrolled from 9 co-operating hemophilia centers. Patients were treated with 50 units/kg, repeated at 12-hour intervals (6-hour intervals in mucous membrane bleedings), if necessary. A total of 489 infusions were given for the treatment of 165 bleeding episodes (102 joint, 33 muscle and soft tissue, 20 mucous membrane, and 10 emergency bleeds, including 3 central nervous system bleeds and 4 surgical procedures). Bleeding was controlled in 153 episodes (93%). In 130 (78%) of the episodes, hemostasis was achieved with 1 or more infusions within 36 hours. Of these, 36% were controlled with one infusion within 12 hours. An additional 14% of episodes responded after more than 36 hours.

Routine Prophylaxis 

In a multicenter, open-label, prospective, randomized clinical trial comparing patients receiving Feiba for prophylaxis with patients receiving Feiba for on-demand treatment, 36 hemophilia A and B patients with inhibitors to factor VIII or IX were analyzed in the intent-to-treat analysis. Patients were randomized to receive 12 months of prophylactic or on-demand treatment with Feiba. Seventeen patients randomized to the prophylaxis arm received 85 units/kg of Feiba every other day. Nineteen patients randomized to the on-demand arm received Feiba for the treatment of acute bleeding episodes per the dose and dosing regimen recommended. Target joints were defined as ≥4 bleeding episodes within 6 months. In this trial, ankles, knees, elbows and hips were target joint locations. Preexisting target joints were not considered as new target joints.

Hemostatic efficacy for treatment of acute bleeds was evaluated at 6 and 24 hours according to a pre-specified four-point scale of excellent, good, fair, or none. An evaluation of “none” was considered a treatment failure. The criteria for evaluation of the effectiveness were relief of pain, cessation of bleeding, and number of infusions required to treat a bleed. 

A total of 825 bleeding episodes were reported including 196 that occurred during prophylaxis and 629 that occurred during on-demand therapy. A majority (78%) of the 794 bleeding episodes that were rated for efficacy were treated with 1 or 2 infusions. Hemostatic efficacy was rated as excellent or good for 74% of bleeding episodes rated at 6 hours post infusion and for 87% of the bleeding episodes at 24 hours post infusion. A total of 19 (2.4%) bleeds were rated as “none” at 6 hours post infusion; 1 bleed (0.1%) was rated “none” at 24 hours.

Hemostatic efficacy for routine prophylaxis was evaluated against patients who received on-demand therapy. 

The overall median annual bleed rate (ABR) for the on-demand arm was 28.7 compared to 7.9 for the prophylaxis arm, which represents a 72% reduction in median ABR with prophylaxis. When analyzed by site (eg, joint, non-joint) and cause of bleeding (eg, spontaneous, traumatic), prophylactic treatment with Feiba resulted in a >50% reduction in ABR. There were fewer patients in the prophylaxis arm who developed new target joints (7 new target joints in 5 patients treated with prophylaxis compared to 23 new target joints in 11 patients in the on-demand arm). Target joints developed in 2 patients in the on-demand arm and 3 in the prophylaxis arm who did not have reported target joints at trial enrollment. A total of 3 of 17 (18%) patients had no bleeding episodes on prophylaxis. In the on-demand arm, all patients experienced a bleeding episode.

Feiba Note


Report all infections suspected to be transmitted by Feiba to (800) 423-2862.

Feiba Patient Counseling

Patient Counseling

Inform patients:

  • of the signs and symptoms of thrombosis, such as chest pain or pressure, shortness of breath, altered consciousness, vision, or speech, limb or abdomen swelling and/or pain. Patients should seek immediate medical attention if any of these symptoms occur.
  • of the signs and symptoms of hypersensitivity reactions, such as urticaria, angioedema, gastrointestinal manifestations, bronchospasm, and hypotension. Patients should discontinue use of the product if these symptoms occur and seek immediate emergency treatment.
  • that because Feiba is made from human blood, it may carry a risk of transmitting infectious agents, eg, viruses, the variant CreutzfeldtJakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
  • if they are on emicizumab prophylaxis therapy and need Feiba to treat a breakthrough bleeding episode then they must be monitored by their hemophilia treating physician, preferably at the hemophilia treatment center (HTC).
  • to report any adverse reactions or problems following Feiba administration to their hemophilia treating physician.

Cost Savings Program

The Feiba savings program is available here.