Feiba Special Precautions

Special Precautions for Use: Allergic-Type Hypersensitivity Reactions: FEIBA can precipitate allergic-type hypersensitivity reactions that have included, urticaria, angioedema, gastrointestinal manifestations, bronchospasm, and hypotension; these reactions can be severe and can be systemic (e.g., anaphylaxis with urticaria and angioedema, bronchospasm, and circulatory shock). Other infusion reactions, such as chills, pyrexia, and hypertension have also been reported.
At the first sign or symptom of an infusion/hypersensitivity reaction, FEIBA administration should be stopped and medical care initiated as appropriate.
When considering re-exposure to FEIBA in patients with known or suspected hypersensitivity to the product, the expected benefit and the risk of re-exposure must be carefully weighed, taking into account the known or suspected type of the patient's hypersensitivity (allergic or non-allergic), including potential remedial and/or preventative therapy or alternative therapeutic agents.
Minor reactions may be controlled by antihistamines. In case of shock, the current medical standards for shock treatment are to be observed.
As the quantity of sodium in the maximum daily dose may exceed 200 mg, special care should be taken with individuals on a low sodium diet.
Risk of Thromboembolic Events: Thromboembolic events, including disseminated intravascular coagulation (DIC), venous thrombosis, pulmonary embolism, myocardial infarction, and stroke, have occurred in the course of treatment with FEIBA.
Some of these events occurred with doses above 200 U/kg/day or in patients with other risk factors (including DIC, advanced atherosclerotic disease, crush injury or septicemia) for thromboembolic events. Concomitant treatment with recombinant Factor VIIa may increase the risk of developing a thromboembolic event.
The possible presence of such risk factors should always be considered in patients with congenital and acquired hemophilia.
FEIBA should be used with particular caution in patients at risk of DIC, arterial or venous thrombosis.
Thrombotic microangiopathy (TMA) has not been reported in FEIBA clinical studies. Cases of TMAs were reported in an emicizumab clinical trial where subjects received FEIBA as part of a treatment regimen for breakthrough bleeding. The safety and efficacy of FEIBA for breakthrough bleeding in patients receiving emicizumab has not been established. Consider the benefits and risks if FEIBA must be used in a patient receiving emicizumab prophylaxis. If treatment with FEIBA is considered required for patients receiving emicizumab, patients must be closely monitored by their physicians.
At the first signs or symptoms of thromboembolic events, the infusion should be stopped immediately and appropriate diagnostic and therapeutic measures initiated.
Monitoring of Therapy: Single dose of 100 U/kg bw and daily dose of 200 U/kg bw should not be exceeded unless the severity of bleeding warrants and justifies the use of higher doses.
When used to stop bleeding, the product should be given only for as long as absolutely necessary to achieve the therapeutic goal.
In case of significant clinical 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 results indicative of DIC are decreased fibrinogen values, decreased platelet count, and/or presence of fibrin/fibrinogen degradation products (FOP). Other indications of DIC include significantly prolonged thrombin time, prothrombin time, or aPTT.
Non-Haemophilic Patients: Non-haemophilic patients with acquired inhibitor against factors VIII, XI or XII may have both, a bleeding tendency and an increased risk of thrombosis at the same time.
Laboratory Tests and Clinical Efficacy: In vitro tests to control efficacy such as aPTT, whole blood clotting time (WBCT), and thromboelastogramme (TEG) may not correlate with clinical improvement. For this reason, attempts to normalize these values by increasing the dose of FEIBA may not be successful and are strongly discouraged because of the potential hazard of inducing DIC by overdosage.
Significance of Platelet Count: In case of inadequate response to treatment with FEIBA it is recommended to perform a platelet count, since a sufficient number of functionally intact platelet is considered necessary for the efficacy of FEIBA.
Precautions: 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.
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.
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).
The amount of sodium in the maximum daily dose may exceed the recommended daily allowance of dietary sodium for patients on a low sodium diet. In these patients, the amount of sodium from the product should be calculated and taken into account when determining dietary sodium intake.
FEIBA 500 U contains approximately 40 mg sodium (calculated) per vial.
The recording of the product name and batch number is strongly recommended following each administration of this product in order to be able to identify the batch of product received.
Effects on Ability to Drive and Use Machines: There are no indications that the product may impair the ability to drive or to operate 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.