FDA label c517a3aa-7ee7-47b5-9382-9741590694f8

WARNING Thrombotic and thromboembolic events have been reported during postmarketing surveillance following infusion of FEIBA VH or FEIBA NF, particularly following the administration of high doses and/or in patients with thrombotic risk factors (See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS).

WARNINGS Anaphylactoid Reactions Allergic reactions, including severe anaphylactoid reactions, have been reported following infusion of FEIBA. If signs and symptoms of severe allergic reactions occur, immediately discontinue administration of FEIBA NF and provide appropriate supportive care. Epinephrine and other appropriate medications to treat allergic reactions should be available whenever FEIBA NF is administered. Thrombotic and Thromboembolic Events Thrombotic and thromboembolic events [including disseminated intravascular coagulation (DIC), venous thrombosis, pulmonary embolism, myocardial infarction, and stroke] have been reported following infusion of FEIBA VH or FEIBA NF, particularly following the administration of high doses and/or in patients with thrombotic risk factors (see ADVERSE REACTIONS ). The possible presence of such risk factors should always be considered in patients with congenital and acquired hemophilia. Thromboembolic events are well recognized potential complications of FEIBA infusion. Many of these events occurred with doses above 200 units/kg/day or in patients with other risk factors for thromboembolic events. A single dose of 100 units/kg body weight and a daily dose of 200 units/kg body weight should not be exceeded unless the severity of bleeding warrants and justifies the use of higher doses. Patients receiving more than 100 units/kg of body weight of FEIBA NF must be monitored for the development of DIC and/or symptoms of acute coronary ischemia. High doses of FEIBA NF should be given only as long as absolutely necessary to stop bleeding. Patients with disseminated intravascular coagulation (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 (TF) or predisposing coagulopathy. FEIBA NF should be used with particular caution and only if there are no therapeutic alternatives in patients: at risk of DIC, arterial or venous thrombosis. with existing thrombotic conditions (e.g., acute myocardial infarction, or venous thrombosis). FEIBA NF should not be given to patients with significant signs of disseminated intravascular coagulation (DIC) or fibrinolysis. Infusion of FEIBA NF should not exceed single dosage of 100 units per kg of body weight and daily doses of 200 units per kg body weight. Thrombotic events have been identified through post-marketing surveillance following FEIBA use for each of the approved indications. The incidence of thrombotic events cannot be determined from post-marketing data. Transmission of Infectious Agents FEIBA NF (Anti-Inhibitor Coagulant Complex), nanofiltered and vapor heated, is made from human plasma. Products made from plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by effective donor screening, testing for the presence of certain current virus infections, by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically the Creutzfeldt-Jakob disease (CJD) agent. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly non-A, non- B hepatitis. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other health care provider to Baxter Healthcare Corporation, at 1-800-423-2862 (in the U.S.). The physician should discuss the risks and benefits of this product with the patient. Anamnestic Responses Anamnestic responses with rise in Factor VIII inhibitor titer have been observed in 20% of the cases (see CLINICAL STUDIES ).

Anaphylactoid Reactions Allergic reactions, including severe anaphylactoid reactions, have been reported following infusion of FEIBA. If signs and symptoms of severe allergic reactions occur, immediately discontinue administration of FEIBA NF and provide appropriate supportive care. Epinephrine and other appropriate medications to treat allergic reactions should be available whenever FEIBA NF is administered.

Thrombotic and Thromboembolic Events Thrombotic and thromboembolic events [including disseminated intravascular coagulation (DIC), venous thrombosis, pulmonary embolism, myocardial infarction, and stroke] have been reported following infusion of FEIBA VH or FEIBA NF, particularly following the administration of high doses and/or in patients with thrombotic risk factors (see ADVERSE REACTIONS ). The possible presence of such risk factors should always be considered in patients with congenital and acquired hemophilia. Thromboembolic events are well recognized potential complications of FEIBA infusion. Many of these events occurred with doses above 200 units/kg/day or in patients with other risk factors for thromboembolic events. A single dose of 100 units/kg body weight and a daily dose of 200 units/kg body weight should not be exceeded unless the severity of bleeding warrants and justifies the use of higher doses. Patients receiving more than 100 units/kg of body weight of FEIBA NF must be monitored for the development of DIC and/or symptoms of acute coronary ischemia. High doses of FEIBA NF should be given only as long as absolutely necessary to stop bleeding. Patients with disseminated intravascular coagulation (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 (TF) or predisposing coagulopathy. FEIBA NF should be used with particular caution and only if there are no therapeutic alternatives in patients: at risk of DIC, arterial or venous thrombosis. with existing thrombotic conditions (e.g., acute myocardial infarction, or venous thrombosis). FEIBA NF should not be given to patients with significant signs of disseminated intravascular coagulation (DIC) or fibrinolysis. Infusion of FEIBA NF should not exceed single dosage of 100 units per kg of body weight and daily doses of 200 units per kg body weight. Thrombotic events have been identified through post-marketing surveillance following FEIBA use for each of the approved indications. The incidence of thrombotic events cannot be determined from post-marketing data.

Transmission of Infectious Agents FEIBA NF (Anti-Inhibitor Coagulant Complex), nanofiltered and vapor heated, is made from human plasma. Products made from plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by effective donor screening, testing for the presence of certain current virus infections, by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically the Creutzfeldt-Jakob disease (CJD) agent. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly non-A, non- B hepatitis. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other health care provider to Baxter Healthcare Corporation, at 1-800-423-2862 (in the U.S.). The physician should discuss the risks and benefits of this product with the patient.

ADVERSE REACTIONS The following adverse reactions have been identified during post approval use of FEIBA: Myocardial infarction, disseminated intravascular coagulopathy, injection site pain, anaphylactic reaction, hypersensitivity, urticaria, blood pressure decreased, hypoaesthesia, hypoaesthesia facial, embolism. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.