Feiba Special Precautions

Thrombotic and Thromboembolic Complications: In the following situations, FEIBA is to be applied only if no reaction to treatment with suitable blood coagulation factor concentrates can be expected - e.g. in case of a high inhibitor titer and a life-threatening hemorrhage or risk of bleeding (e.g. post-traumatically or postoperatively): Disseminated intravascular coagulation (DIC): laboratory findings and/or clinical symptoms; Liver damage: Due to the delayed clearance of activated coagulation factors, patients with impaired liver function are at increased risk of developing DIC; Coronary heart disease, acute thrombosis and/or embolism.
Patients who receive FEIBA should be monitored for the development of DIC, acute coronary ischemia, and signs and symptoms of other thrombotic or thromboembolic events. At the first signs or symptoms of thrombotic and thromboembolic events, the infusion should be stopped immediately and appropriate diagnostic and therapeutic measures initiated.
Discordant Response to Bypassing Agents: Due to patient-specific factors the response to a bypassing agent can vary, and in a given bleeding situation patients experiencing insufficient response to one agent may respond to another agent. In case of insufficient response to one bypassing agent, use of another agent should be considered.
Anamnestic Responses: Administration of FEIBA to patients with inhibitors may result in an initial "anamnestic" rise in inhibitor levels. Upon continued administration of FEIBA, inhibitors may decrease over time. Clinical and published data suggest that the efficacy of FEIBA is not reduced.
Interference with Laboratory Tests: After administration of high doses of FEIBA, the transitory rise of passively transferred Hepatitis B surface antibodies may result in misleading interpretation of positive results in serological testing.
FEIBA contains blood group isohemagglutinins (anti-A and anti-B). Passive transmission of antibodies to erythrocyte antigens, e.g., A, B, D, may interfere with some serological tests for red cell antibodies, such as antiglobulin test (Coombs test).
Prophylactic use in hemophilia B patients with inhibitors: Due to the rarity of the disease, only limited clinical data is available for the prophylaxis of bleeding in hemophilia B patients (literature case reports, n = 4, and clinical data in prophylaxis study 090701, n = 1).
Transmission of infectious agents: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents, cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV, and for the non-enveloped virus HAV. The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19. Parvovirus B19 infection may be serious for pregnant women (fetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. hemolytic anaemia).
It is strongly recommended that every time that FEIBA is administered to the patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of human plasma-derived products including FEIBA.
Excipient related considerations: FEIBA 25 U/ml contains approximately 4 mg sodium (calculated) per ml; it is approx. 80 mg sodium for the presentation 500 U FEIBA. This is to be taken into consideration in patients on a low sodium diet.
FEIBA 50 U/ml contains approximately 4 mg sodium (calculated) per ml; it is approx. 40 mg sodium for the presentation 500 U FEIBA, approx. 80 mg sodium for the presentation 1000 U FEIBA. This is to be taken into consideration in patients on a low sodium diet.
Effects on the ability to drive and use machines: FEIBA has no, or negligible, influence on the ability to drive or to use machines.
Use in Children: Case reports and limited clinical trial data suggest that FEIBA can be used in children younger than 6 years of age. The same dose regimen as in adults should be adapted to the child's clinical condition.
Use in the Elderly: There are only limited clinical trial data with the use of FEIBA in elderly patients.