FEIBA-NF

What it is

FEIBA-NF is a sterile lyophilised powder containing a complex of coagulation factors , intended for intravenous administration after reconstitution . The potency of FEIBA-NF is expressed in arbitrary units of factor VIII bypassing activity, with one unit defined as that amount of FEIBA-NF that shortens the activated partial thromboplastin time of a high titre Factor VIII inhibitor reference plasma to 50% of the blank value . FEIBA-NF contains Factors II, IX and X, mainly non-activated, and Factor VII mainly in the activated form, with 1–6 units of Factor VIII coagulation antigen per millilitre also present . FEIBA-NF is prepared from pooled human plasma and is subjected to two dedicated viral inactivation steps—vapour heat treatment and nanofiltration . FEIBA-NF is available in three strengths with each vial containing 500 U, 1000 U or 2500 U of factor VIII bypassing activity .

Approved indications —

Routine prophylaxis in haemophilia A or B patients with inhibitors — Control of spontaneous bleeding episodes in haemophilia A or B patients with inhibitors — Use in surgery in haemophilia A or B patients with inhibitors

Dosing overview

As a general rule a dose of 50 to 100 units of FEIBA-NF per kilogram of body weight is recommended, although the total daily dose should not exceed 200 U/kg body weight .

The injection/infusion rate should not exceed 2 units FEIBA-NF per kilogram of body weight per minute .

Key safety warnings

Thromboembolic events, including disseminated intravascular coagulation, venous thrombosis, pulmonary embolism, myocardial infarction and stroke, have occurred in the course of treatment with FEIBA-NF, with some events occurring at doses above 200 U/kg/day or in patients with other risk factors including disseminated intravascular coagulation, advanced atherosclerotic disease, crush injury or septicaemia . Concomitant treatment with recombinant Factor VIIa may increase the risk of developing a thromboembolic event . FEIBA-NF should be used with particular caution in patients at risk of disseminated intravascular coagulation, arterial or venous thrombosis . At the first signs or symptoms of thromboembolic events, the infusion should be stopped immediately and appropriate diagnostic and therapeutic measures initiated . FEIBA-NF can precipitate allergic-type hypersensitivity reactions including urticarial, angioedema, gastrointestinal manifestations, bronchospasm and hypotension, which can be severe and systemic (such as 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 or hypersensitivity reaction, FEIBA-NF administration should be stopped and medical care initiated as appropriate . FEIBA-NF is made from human plasma and products made from human plasma may carry a risk of transmitting infectious agents, such as viruses, the variant Creutzfeldt-Jacob Disease agents and theoretically Creutzfeldt-Jacob Disease agent . The measures taken for FEIBA-NF are considered effective against enveloped viruses such as human immunodeficiency virus, hepatitis B virus and hepatitis C virus, but may be of limited value against non-enveloped viruses such as hepatitis A virus and parvovirus B19 . Appropriate vaccination (hepatitis A and B) should be considered for patients who receive regular or repeated treatment with FEIBA-NF .

Contraindications

The use of FEIBA-NF is contraindicated in patients who are known to have a normal coagulation mechanism . It should not be given to patients with significant signs of disseminated intravascular coagulation or fibrinolysis . In patients with tentative or definite diagnosis of coronary heart disease as well as in patients with acute thrombosis and/or embolism (including myocardial infarction), the use of FEIBA-NF is only indicated in life-threatening bleeding events . FEIBA-NF is contraindicated in cardiac surgery involving cardiopulmonary bypass and procedures involving extracorporeal membrane oxygenation due to the high risk of thrombotic adverse events .

Regulatory history

FEIBA-NF 500 U and 1000 U strengths were first registered on the ARTG on 9 January 2007 . FEIBA-NF 2500 U strength was first listed on 30 March 2012 .