Allergic-type hypersensitivity reactions, including severe anaphylactoid reactions, have been reported following the infusion of FEIBA. The symptoms include urticaria, angioedema, gastrointestinal manifestations, bronchospasm, and hypotension; these reactions can be severe and can be systemic.
Many of the reported cases of thromboembolic events occurred with doses above 200 units/kg/day or in patients with other risk factors.
Infusion of FEIBA NF should not exceed single dosage of 100 U/kg and daily doses of 200 U/kg of body weight. Patients receiving more than 100 U/kg 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.
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.If clinical signs of intravascular coagulation occur, which include changes in blood pressure, changes in pulse rate, respiratory distress, chest pain and/or cough, infusion of FEIBA NF should be stopped promptly. Non-hemophilic patients with acquired inhibitors against factors VIII, IX or XII may have both a bleeding tendency and an increased risk of thrombosis at the same time. FEIBA NF is made from human plasma and may carry a risk of transmitting infectious agents, e.g., viruses and theoretically, the variant Creutzfeldt-Jakob disease (vCJD) agent. Adverse reactions reported in clinical studies with FEIBA were anamnestic response, somnolence, dizziness, dysgeusia, dyspnea, hypoesthesia, nausea, chills, pyrexia, chest pain and chest discomfort. For information on FEIBA NF use in the United States, please visit: http://www.baxter.com/healthcare_professionals/products/feiba_nf.html. Licenses and licensing conditions may vary from country to country; therefore please always consult your local full prescribing information. Please check the FEIBA NF website for information on indications approved in other countries. About Hemophilia A Hemophilia is a rare genetic blood clotting disorder that primarily affects males. 2 People living with hemophilia do not have enough of, or are missing, one of the blood clotting proteins naturally found in blood. Two of the most common forms of hemophilia are A and B. 3 In people with hemophilia A, clotting factor VIII is not present in sufficient amounts or is absent. 2 Without enough FVIII, people with hemophilia can experience spontaneous, uncontrolled internal bleeding that is painful, debilitating, damaging to joints and potentially fatal. 2 According to the World Federation of Hemophilia, it is estimated that more than 400,000 people in the world have hemophilia. 2 All races and economic groups are affected equally. 1 About Hemophilia B Hemophilia B is the second most common type of hemophilia (also known as Christmas disease) and is the result of insufficient amounts of clotting factor IX, a naturally occurring protein in blood that controls bleeding. 4 Approximately 26,000 people worldwide, including more than 4,000 in the U.S., have been diagnosed with hemophilia B. 5 Hemophilia B is often a debilitating, chronic disease with complications that include bleeding episodes, hemophilic arthropathy (bleeding into a joint) and hospitalization. 6 About Inhibitors As many as one-third of patients with severe or moderately severe hemophilia A are at risk for developing inhibitors, which are antibodies produced by the body’s immune system in response to factor replacement therapy. Inhibitors cause the body to work against the factor replacement therapy, neutralizing its effect and preventing an individual’s blood from clotting. 7 Individuals who have inhibitors have a form of hemophilia that is more difficult to control, with an increased risk of uncontrolled bleeding, compared to patients without inhibitors. Inhibitor development is considered one of the most serious complications associated with hemophilia treatment, and may include other associated complications such as impaired movement, increased need for surgery and greater complexity or risk associated with surgery. 8 About Baxter in Hemophilia Baxter has more than 60 years of experience in hemophilia and has introduced a number of therapeutic firsts for hemophilia patients. Baxter has the broadest portfolio of hemophilia treatments in the industry and is able to meet individual therapy choices, providing a range of options at each treatment stage. The company’s work is focused on optimizing hemophilia care and improving the lives of people living with hemophilia A and B worldwide.