Source: Health Products Regulatory Authority (IE) Revision Year: 2011 Publisher: Baxter Healthcare Limited, Caxton Way, Thetford, IP243 SE, Norfolk, United Kingdom
FEIBA must not be used in the following situations if therapeutic alternatives to FEIBA are available:
In the following situations FEIBA should only be used if – for example due to a very high inhibitor titre – no response to treatment with the appropriate coagulation factor concentrate can be expected.
See section 4.4.
Thrombotic and thromboembolic events, including disseminated intravascular coagulation (DIC), venous thrombosis, pulmonary embolism, myocardial infarction, and stroke, have occurred in the course of treatment with FEIBA.
The risk of thrombotic and thromboembolic events may be increased with high doses of FEIBA. Many of these events occurred with doses above 200 U/kg/day or in patients with other risk factors for thromboembolic events. The possible presence of such risk factors should always be considered in patients with congenital and acquired hemophilia.
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):
As with any intravenously administered protein preparation, allergic type hypersensitivity reactions may occur. Patients should be informed of the early signs of hypersensitivity reactions, for example erythema, skin rash, generalized urticaria, pruritus, breathing difficulties/dyspnoea, tightness of the chest, general indisposition, dizziness and drop in blood pressure up to allergic shock. If these symptoms occur, patients should be advised to discontinue the treatment and to contact their physician immediately. Shock is treated according to the rules of modern shock therapy.
When considering re-exposure to FEIBA in patients with suspected hypersensitivity to the product or any of its components, 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.
Individual doses of 100 U/kg body weight and daily doses of 200 U/kg body weight must not be exceeded. Patients who receive an individual dose of 100 U/kg body weight are to be monitored carefully, particularly with regard to the development of a DIC or the occurrence of symptoms of acute coronary ischemia. High doses of FEIBA should be administered only as long as strictly necessary – in order to stop a hemorrhage.
If clinically significant changes in blood pressure or pulse rate, respiratory distress, coughing or chest pain occur, the infusion is to be discontinued immediately and appropriate diagnostic and therapeutic measures are to be initiated. Significant laboratory parameters for DIC are a drop in fibrinogen, a drop of the thrombocyte count and/or the presence of fibrin/fibrinogen degradation products (FDP). Other parameters for DIC are a clearly prolonged thrombin time, prothrombin time or aPTT. In patients with inhibitor hemophilia or with acquired inhibitors to factors VIII, IX and/or XI, the aPTT is prolonged by the underlying disease.
Patients with inhibitor hemophilia or with acquired inhibitors to coagulation factors, who are treated with FEIBA, may have increased bleeding tendency as well as increased risk of thrombosis at the same time.
In vitro tests, such as aPTT, whole blood coagulation time (WBCT) and thromboelastograms (TEG) as proof of efficacy do not have to correlate with the clinical picture. Therefore, attempts to normalize these values by increasing the dose of FEIBA cannot be successful, and are even to be strongly rejected because of the possible risk of triggering a DIC through overdosing.
If the response to treatment with FEIBA is inadequate, conducting a thrombocyte count is recommended since a
sufficient number of functionally intact thrombocytes is necessary for the efficacy of FEIBA.
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 excluded completely. 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 Β19. Parvovirus Β19 infection may be serious for pregnant women (fetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia).
Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of human plasma-derived Factor VIII inhibitor products.
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.
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.
Only limited clinical data is available on the application of FEIBA for the prophylaxis of bleeding in hemophilia patients.
FEIBA 1000 U contains approximately 80 mg sodium (calculated) per vial. This is to be taken into consideration in patients on a low sodium diet.
It is not recommended to administer antifibrinolytics, such as epsilon aminocaproic acid, together with FEIBA.
If application of both, antifibrinolytics such as epsilon aminocaproic acid and FEIBA, is indicated, the interval between the administration of these two products must be at least 6 hours.
The safety of FEIBA during pregnancy and lactation has not been established.
Physicians should carefully consider the potential risks and benefits for each specific patient before prescribing FEIBA.
Pregnancy and the postpartum period are characterized by an increased risk of thrombosis, and several complications of pregnancy are associated with an increased risk of DIC.
No animal reproduction studies have been conducted with FEIBA.
FEIBA has no, or negligible, influence on the ability to drive or to use machines.
The adverse reactions listed in the following were reported within the framework of either post-marketing surveillance or clinical trials.
Frequency categories: very common >1/10, common >1/100 to <1/10, uncommon >1/1,000 to <1/100, rare >1/10,000 to <1/1,000, very rare <1/10,000, not known cannot be estimated from the available data.
Not known: Disseminated intravascular coagulation (DIC), Increase of inhibitor titer (anamnestic response)a
Not known: Hypersensitivity reactions, Urticaria, Anaphylactic reaction
Not known: Paresthesia, Hypaesthesia, Thrombotic stroke, Embolic stroke, Headache, Somnolence, Dizziness, Dysgeusia
Not known: Cardiac infarction, Tachycardia
Not known: Embolism (thromboembolic complications), Hypotension, Hypertension, Flushing
Not known: Pulmonary embolism, Bronchospasm, Wheezing, Cough, Dyspnea
Not known: Vomiting, Diarrhea, Abdominal discomfort, Nausea
Not known: Sensation of numbness in the face, Angioedema, Urticaria, Pruritus, Rash
Not known: Pain at the injection site, Malaise, Feeling hot, Chills, Pyrexia, Chest pain, Chest discomfort
Not known: Drop in blood pressure
a Increase of inhibitor titer (anamnestic response) [not a MedDRA PT] is the rise of previously existing inhibitor titers occurring after the administration of FEIBA. See Section 4.4.
Rapid intravenous infusion may cause stabbing pain and a feeling of numbness in face and limbs, as well as a drop in blood pressure.
Thromboembolic events might occur after the administration of doses above the maximum daily dose and/or prolonged application, see Section 4.4 -
For safety with respect to transmissible agents, see Section 4.4.
This medicinal product must not be mixed with other medicinal products except the solvent mentioned in Section 6.6. As in all blood coagulation preparations, the efficacy and tolerance of the medicinal product may be impaired by being mixed with other medicinal products. It is advisable to rinse a common venous access with a suitable solution, e.g. with isotonic saline solution, before and after the administration of FEIBA.
Coagulation factors derived from human plasma may be adsorbed by the inner surfaces of certain types of injection/infusion devices. If this were to occur, it could result in failure of therapy. Therefore, only approved plastic infusion devices may be used with FEIBA.
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