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Mechanism of Action
US Drug Names
NOTE: 1 unit of activity is defined as the amount of FEIBA that shortens the aPTT of high titer factor VIII inhibitor reference plasma to 50% of the blank value.
NOTE: FEIBA is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to factor VIII or factor IX.
50 to 100 units/kg/dose IV every 12 hours until pain and acute disabilities are improved.
50 to 100 units/kg/dose IV every 6 hours for at least 1 day or until bleeding is resolved.
100 units/kg/dose IV every 12 hours until resolution of bleeding.
100 units/kg/dose IV every 6 to 12 hours until resolution of bleeding.
50 to 100 units/kg/dose IV as a single dose immediately prior to surgery.
50 to 100 units/kg IV every 6 to 12 hours until resolution of bleeding and healing are achieved.
50 to 100 units/kg/dose IV every 6 to 12 hours until resolution of bleeding and healing are achieved.
85 units/kg/dose IV every other day.
30 units/kg IV over 15 minutes just prior to neurosurgery was reported in 1 geriatric patient receiving rivaroxaban 20 mg daily who developed a subdural hematoma with a midline shift after a fall.
25 units/kg (rounded to vial size, 27.5 units/kg), 26 units/kg, 42 units/kg, 50 units/kg, or 100 units/kg IV once doses are described in various case reports. Following an initial dose of 26 units/kg IV, a second dose of 16 units/kg IV was administered in a single case due to concerns for rebleeding.  
100 units/kg/dose IV or 200 units/kg/day IV.
Safety and efficacy have not been established.
No dosage adjustments are needed.
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
Anti-inhibitor coagulant complex (AICC) is derived from human plasma. Anti-inhibitor coagulant complex is similar to prothrombin complex concentrates (PCCs or factor IX complexes), but AICC has undergone in vitro activation resulting in an increased amount of activated and precursor vitamin K-dependent clotting factors (factors II, VII, IX, and X). Anti-inhibitor coagulant complex is used as coagulation factor bypass therapy in patients with hemophilia with inhibitors or in patients with acquired inhibitors to other clotting factors. In patients with high inhibitor titers (more than 10 Bethesda Units) or who rapidly develop inhibitors following exposure to factor products (high responders), AICC provides activated clotting factors and controls bleeding in about 80% to 90% of patients with 1 or 2 doses. FEIBA products contain factors II, IX, and X, which are mainly inactivated, and factor VII, which is mainly activated. FEIBA contains only trace amounts of factors of the kinin generating system and no heparin. The activity of FEIBA is expressed in arbitrary units; 1 unit of activity is defined as the amount of FEIBA that shortens the aPTT of high titer factor VIII inhibitor reference plasma to 50% of the blank value. These products undergo processes that are designed to reduce the risk of infectious contamination.
For storage information, see the specific product information within the How Supplied section.
Hypersensitivity and allergic reactions, including severe anaphylactoid reactions, have been reported in patients receiving anti-inhibitor coagulant complex (AICC). 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). Pruritus and wheezing have also been reported during postmarketing use. Discontinue administration immediately and provide appropriate supportive care if signs and symptoms of a severe allergic reaction occurs.
Injection site reaction (i.e., injection site pain) has been reported during postmarketing use of anti-inhibitor coagulant complex (AICC). Infusion-related reactions, such as chills, fever, and hypertension, have also been reported.
Thromboembolism including venous thrombosis, pulmonary embolism, myocardial infarction, and stroke can occur with anti-inhibitor coagulant complex (AICC), especially after the administration of high doses (more than 200 units/kg/day) and/or in patients with thrombotic risk factors. Disseminated intravascular coagulation (DIC) has been reported with postmarketing use. Monitor patients receiving more than 100 units/kg for the development of DIC, acute coronary ischemia, and signs and symptoms of other thromboembolic events. Discontinue the infusion and initiate appropriate diagnostic and therapeutic measures if symptoms occur.
Anti-inhibitor coagulant complex (AICC) products are derived from human plasma donors and carry the possibility of causing iatrogenic infection via blood borne pathogens. The risk with AICC is considered to be low due to the careful screening of plasma donors and manufacturing processes. However, new blood borne pathogens not controlled by present measures can theoretically emerge at any time.
Hypoesthesia, dizziness, and drowsiness were reported in clinical trials of anti-inhibitor coagulation complex (AICC) for the treatment of acute bleeding episodes. Malaise and feeling hot (hot flashes) have been reported with postmarketing use.
In a clinical trial of anti-inhibitor coagulant complex (AICC) for prophylaxis, the most frequently reported gastrointestinal-related adverse reactions observed in more than 5% of subjects were diarrhea (5.6%), nausea (5.6%), and vomiting (5.6%). Dysgeusia and nausea were also reported in clinical trials of AICC for acute bleeding episodes. Abdominal discomfort has been reported during postmarketing use.
Anemia (5.6%) and hemarthrosis (8.3%) were reported in a clinical trial of anti-inhibitor coagulant complex (AICC) for prophylaxis. Chest pain (unspecified), chest discomfort, and dyspnea were reported during acute bleeding clinical trials. Sinus tachycardia and flushing have been reported during postmarketing use.
Anti-inhibitor coagulant complex is contraindicated in patients with known anaphylactic or severe hypersensitivity reactions toanti-inhibitor coagulant complex or any of its components, including factors of the kinin generating system.
Anti-inhibitor coagulant complex (AICC) is contraindicated in patients with disseminated intravascular coagulation (DIC) and patients with acute thrombosis or embolism, including myocardial infarction. Thromboembolism, including DIC, venous thrombosis, pulmonary embolism, myocardial infarction, and stroke, have been reported following AICC administration. Many of these events occurred after high doses (more than 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 thrombosis due to predisposing coagulopathy or circulating tissue factor. Potential benefit of treatment with AICC should be weighed against risk for thromboembolic event. Monitor patients receiving AICC more than 100 units/kg for signs and symptoms of DIC, acute coronary ischemia, and other thromboembolic events. If signs or symptoms such as chest pain or pressure, shortness of breath, altered consciousness, vision, or speech, limb or abdomen swelling and/or pain occur, discontinue the AICC infusion and initiate appropriate diagnostic and therapeutic measures.
Anti-inhibitor coagulant complex (AICC) is derived from human plasma and may therefore carry a risk of transmitting viral infection, and theoretically, the Creutzfeldt-Jakob disease agent. Screening plasma donors for prior exposure to certain viruses, testing for the presence of viruses, and inactivating and/or reducing viruses has reduced the risk of transmission of infectious agents; however, none of the processes are completely effective. All infections thought to have been transmitted by AICC should be reported to the manufacturer and/or the FDA (1-800-FDA-1088 or www.fda.gov/medwatch).
An inadequate response to anti-inhibitor coagulant complex (AICC) may be seen in patients with thrombocytopenia or abnormal platelet function which were present prior to treatment with AICC.
It is not known whether anti-inhibitor coagulant complex (AICC) can affect reproduction capacity or cause fetal harm when administered during human pregnancy. Animal studies have not been conducted. Use AICC during pregnancy only if clearly needed.
There is no information regarding the presence of anti-inhibitor coagulant complex (AICC) in human milk, the effect on the breast-fed child, or the effects on milk production Because many drugs are excreted in human milk, exercise caution when AICC is administered to a breast-feeding mother. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
In some cases, laboratory tests such as activated thromboplastin time (aPTT) may not correlate with clinical response of anti-inhibitor complex (AICC) treatment. Hemostatic improvement may occur without a reduction in aPTT. However, a shortened prothrombin time (PT) would be expected. Attempts to normalize these parameters by increasing the doses of AICC is not recommended due to the increased risk of disseminated intravascular coagulation (DIC) associated with increased doses. In children, fibrinogen levels should be determined prior to and monitored during AICC treatment.
Anti-inhibitor coagulant complex (AICC) provides activated coagulation factors to restore hemostasis in patients with inhibitors to certain coagulation factors. The actual active component of AICC has not been identified and may include activated factor VII, activated factor X with or without phospholipid or a combination of factors. Anti-inhibitor coagulant complex may induce a hypercoagulable state leading thrombosis or disseminated intravascular coagulation due to the administration of activated factors, presence of circulating tissue factor and the underlying coagulopathy. Administration of AICC results in changes in coagulation parameters, most notably prothrombin time (PT); however, the degree of change may not reflect the actual clinical effect.
Anti-inhibitor coagulant complex (AICC) is administered intravenously. The onset of activity is dependent upon the amount of activated factor present, type of inhibitor present, and the half-lives of the factors. The half-lives of the factors present in AICC are as follows: factor II, more than 60 hours; factor VII, 4 to 6 hours; factor IX, 20 to 24 hours; and factor X, 48 to 72 hours.
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