WARNINGS
FEIBA VH Anti-Inhibitor Coagulant Complex, 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-Jacob disease (CJD) agent. 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. FEIBA VH Anti-Inhibitor Coagulant Complex, Vapor Heated must be used only in patients with circulating inhibitors to one or more coagulation factors and should not be used for the treatment of bleeding episodes resulting from coagulation factor deficiencies. It should not be given to patients with significant signs of disseminated intravascular coagulation (DIC) or fibrinolysis.
Thromboembolic events may occur in the course of treatment with preparations containing the prothrombin complex, particularly following the administration of high doses and/or in patients with thrombotic risk factors.
Infusion of FEIBA VH AICC should not exceed single dosage of 100 units per kg of body weight and daily doses of 200 units per kg of body weight. Patients receiving more than 100 units per kg of body weight of FEIBA VH AICC must be monitored for the development of DIC and/or symptoms of acute coronary ischemia (see Adverse Reactions section).
High doses of FEIBA VH AICC should be given only as long as absolutely necessary to stop bleeding.
It has been reported that FEIBA VH AICC and antifibrinolytics have been given simultaneously without complications. It is, however, recommended not to use antifibrinolytics until 12 hours after the administration of FEIBA VH AICC.
Anamnestic responses with rise in Factor VIII inhibitor titer have been observed in 20% of the cases (see Clinical Pharmacology section).
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.
PRECAUTIONS
MONITORING OF THERAPY
If clinical signs of intravascular coagulation occur, which include changes in blood pressure, pulse rate, respiratory distress, chest pain and cough, the infusion should be stopped promptly and appropriate diagnostic and therapeutic measures are to be initiated.
Laboratory indications of DIC are decreased fibrinogen, decreased platelet count, and/or presence of fibrin-fibrinogen degradation products (FDP). Other indications of DIC include significantly prolonged thrombin time, prothrombin time, or partial thromboplastin time.
INFORMATION FOR PATIENTS
Some viruses, such as parvovirus B19 or hepatitis A, are particularly difficult to remove or inactivate at this time. Parvovirus B19 most seriously affects pregnant women or immune-compromised individuals. Symptoms of parvovirus B19 infection include fever, drowsiness, chills, and runny nose followed about two weeks later by a rash, and joint pain. Evidence of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and pain in the belly. Dark urine and a yellowed complexion are also common symptoms. Patients should be encouraged to consult their physician if such symptoms appear.
NON-HEMOPHILIC PATIENTS
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.
LABORATORY TESTS AND CLINICAL EFFICACY
Tests used to control efficacy such as APTT, WBCT, and TEG do not correlate with clinical improvement. For this reason, attempts at normalizing these values by increasing the dose of FEIBA VH Anti-Inhibitor Coagulant Complex,Vapor Heated may not be successful and are strongly discouraged because of the potential hazard of producing DIC by overdose.
PREGNANCY CATEGORY C
Animal reproduction studies have not been conducted with FEIBA VH AICC. It is also not known whether FEIBA VH AICC can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. FEIBA VH AICC should be given to a pregnant woman only if clearly needed.
PEDIATRIC USE
No data are available regarding the use of FEIBA VH AICC in newborns.
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