FEIBA NF - Consumer Medicine Information
|Condition:||Hemophilia, Hemophilia A, Hemophilia B|
|Class:||Miscellaneous coagulation modifiers|
|Form:||Intravenous (IV), Powder|
|Ingredients:||anti-inhibitor coagulant complex, sodium chloride, trisodium citrate|
Anti-Inhibitor Coagulant Complex, Vapor Heated andNanofiltered
About this medication
What the medication is used for:
Anti-Inhibitor Coagulant Complex, Vapor Heated, and Nanofiltered FEIBA NF is indicated for the control of spontaneous bleeding episodes, to cover surgical interventions in haemophilia A and B patients with inhibitors and routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children older than 6 years of age with hemophilia A or B with inhibitors.
In addition, FEIBA NF may be used for treating non-haemophiliacs with acquired inhibitors to factors VIII, XI and XII in case of life-threatening haemorrhages5-12. One case has been reported where FEIBA was effective in a patient with von Willebrand's disease with an inhibitor16.
Clinical experience suggests that patients with a Factor VIII inhibitor titer of less than 5 B.U. may be successfully treated with Antihemophilic Factor. Patients with titers ranging between 5 and 10 B.U. may either be treated with Antihemophilic Factor or FEIBA NF. Cases with Factor VIII inhibitor titers greater than 10 B.U. have generally been refractory to treatment with Antihemophilic Factor.
Guidelines to First and Second Choice Treatment:
AICC = Anti-Inhibitor Coagulant Complex, Vapor Heated and Nanofiltered, FElBA NF
AHF = Antihemophilic Factor
|less than 5|
5 to 10 B.U.
|more than 10|
Inadequate response to treatment may result from an abnormal platelet count or impaired platelet function13-15 which were present before treatment with FEIBA NF.
What it does:
FEIBA NF is used for the treatment of hemorrhages in hemophilia A and B patients with inhibitors.
Furthermore, FEIBA NF can be used for the treatment of hemorrhages in non -hemophilic patients who have developed inhibitors to factors VIII, IX and XI.
FEIBA NF has been used in combination with factor VIII concentrate during ITI until eradication of inhibitors.
When it should not be used:
The use of Anti-Inhibitor Coagulant Complex, Vapor Heated, and Nanofiltered FEIBA NF is contraindicated in patients who are known to have a normal coagulation mechanism and in patients who have hypersensitivity to the product.
It should not be given to patients with significant signs of disseminated intravascular coagulation (DIC) or fibrinolysis. In patients with a 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.
What the medicinal ingredient is:
Anti-Inhibitor Coagulant Complex
What the important nonmedicinal ingredients are:
Sodium Chloride and Trisodium Citrate
For a full listing of nonmedicinal ingredients see Part 1 of the product monograph.
What dosage forms it comes in:
Anti-Inhibitor Coagulant Complex, Vapor Heated and Nanofiltered, FEIBA NF is supplied as freeze-dried powder, accompanied by a suitable volume of Sterile Water for Injection, E. P., and a Baxject II Hi-Flow device.
The number of FEIBA Units of Factor VIII inhibitor bypassing activity is stated on the label of each bottle (400 – 1200 Units per 20ml, 1750 - 3250 Units per 50ml).
Warning and precautions
Serious Warnings and Precautions
Thromboembolic events have been reported during post-marketing surveillance following infusion of FEIBA, particularly following the administration of high doses and/or in patients with thrombotic risk factors (see WARNING AND PRECAUTIONS AND ADVERSE EVENTS).
Anti-Inhibitor Coagulant Complex, Vapor Heated, and Nanofiltered, FEIBA NF 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.
FEIBA should be used with particular caution in patients at risk of DIC, arterial or venous thrombosis. At first signs or symptoms of Thromboembolic events, the infusion should be stopped immediately and appropriate diagnostic and therapeutic measures initiated.
Thromboembolic events, including disseminated intravascular coagulation (DIC), venous thrombosis, pulmonary embolism, myocardial infarction and stroke, have occurred in the course of treatment with FEIBA.. Many 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 (e.g. patients in the postoperative state or with liver disease, infection, inflammation, cancer, angina pectoris or myocardial infarction). 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 can precipitate allergic-type hypersensitivity reactions that have included urticaria, angiodema, 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). Allergic Reactions should be treated with antihistamines and glucocorticoids. In the case of shock medical attention should be initiated as appropriate. Other infusion reactions, such as chills, pyrexia, and hypertension have also been reported.
At first signs or symptoms of an infusion/hypersensitivity reaction, FEIBA administration should be stopped and medical care initiated as appropriate.
Anamnestic response with rise in Factor VIII inhibitor titer have been observed in 20% of the cases. Clinical and published data suggests that the efficacy of FEIBA is not reduced.
Interactions whith medication
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
No adequate and well-controlled studies of the combined or sequential use of FEIBA and recombinant Factor VIIa or antifibrinolytics have been conducted.
The possibility of thromboembolic events should be considered when systemic antifibrinolytics such as tranexamic acid and aminocaproic acid are used during treatment with FEIBA. Therefore, antifibrinolytics should not be used for approximately 6 to 12 hours after the administration of FEIBA.
In cases of concomitant rFVIIa use, according to available in vitro data and clinical observations a potential drug interaction may occur (potentially resulting in adverse events such as a thromboembolic event.)
As all other blood coagulation factors, FEIBA should not be mixed with other medicinal products prior to application since this might impair the efficacy and safety of the product.
Proper use of this medication
Reconstitute the freeze -dried FEIBA powder with the enclosed solvent and administer the solution intravenously.
Always use FEIBA exactly as your doctor has instructed you. Please ask your doctor or pharmacist, if you are not entirely sure. Taking into consideration the severity of the blood coagulation disorder, the location and extent of the hemorrhage, and your general condition and response to the preparation, the doctor has determined the dose and dosage intervals required for you personally. Do not change the dosage established by your doctor and do not discontinue the application of the preparation independently.
Warm the product to room or body temperature prior to administration.
FEIBA is to be reconstituted only immediately before administration. The solution should then be used immediately (the preparation does not contain preservatives). Solutions, which are turbid or have deposits are to be disposed of appropriately. Do not reuse opened containers. Do not use the product, if its sterile barrier system or its packaging is damaged or it shows any sign of deterioration.
As a general guideline a dosage range of 50 to 100 FEIBA Units of FEIBA NF per kg of body weight is recommended. However, care should be taken to distinguish between the following indications, all of which have undergone careful clinical evaluation:
- Joint haemorrhages
- Mucous Membrane Bleeding
- Soft tissue haemorrhages
- Other severe haemorrhages
A single dose of 100 U/kg body weight and a daily dose of 200 U/kg body weight should not be exceeded.
For prevention of bleeding episodes, dose 85 ± 15 units per kg body weight (70 to 100 units per kg body weight) every other day (3 to 4 times weekly). Dose to be adjusted based on the patient’s clinical response.
Some of the reported thromboembolic events occurred with doses above 200 U/kg . If signs or symptoms of thromboembolic events are observed, the infusion should be stopped immediately and appropriate diagnostic and therapeutic measures initiated.
|In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.|
Side effects and what to do about them
If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
After application of high doses (single infusion of beyond 100 U/kg of body weight, and daily doses of 200 U/kg bw) of Anti-Inhibitor Coagulant Complex, Vapor-Heated, and Nanofiltered, FEIBA NF, laboratory and/or clinical signs or DIC have occasionally been observed.
As with all human plasma products, any kind of allergic reaction may be seen, ranging from mild, short-term urticarial rashes to severe anaphylactoid reactions.
Administration of FEIBA NF should be discontinued immediately, if such signs appear. Allergic reactions should be treated with antihistamines and glucocorticoids. In the case of shock medical attention should be initiated as appropriate.
This is not a complete list of side effects. For any unexpected effects while taking FEIBA NF, contact your doctor or pharmacist.
How to store it
FEIBA NF can be stored refrigerated or at room temperature (between 2°C to +25°C) for the entire shelf-life of the product.
Avoid freezing, which may damage the diluent bottle.
FEIBA NF must not be used beyond the expiry date indicated on the label.
Anti-Inhibition Coagulant Complex, Vapor Heated and Nanofiltered, FEIBA NF is to be reconstituted only immediately before administration. The solution should then be used promptly. Any unused solution must be discarded.
Instructions for Using FEIBA NF
Instructions for use for BAXJECT II Hi-Flow: Reconstitution of powder to prepare a solution for injections.
Use aseptic technique throughout entire procedure.
- Warm the unopened vial containing the solvent (Sterile Water for Injection, EP) to room temperature if necessary, e.g. using a sterile water bath for warming within several minutes (max.+37°C).
- Remove the protective caps from the FEIBA vial and solvent vial and cleanse the rubber stoppers with germicidal solution of both and allow to dry. Place the vials on a flat surface.
- Open the package of BAXJECT II Hi-Flow device by peeling away the paper lid without touching the inside (Fig. a). Do not remove the transfer device from the package.
- Turn the package over and insert the clear plastic spike through the solvent stopper (Fig. b). Grip the package at its edge and pull the package off BAXJECT II Hi-Flow (Fig. c). Do not remove the blue cap from BAXJECT II Hi-Flow.
- With the transfer device attached to the solvent vial, invert the system so that the solvent vial is on top of the device. Insert the purple plastic spike of BAXJECT II Hi-Flow through the FEIBA vial stopper. The vacuum will draw the solvent into the FEIBA vial (Fig. d).
- Swirl gently until all the material is dissolved. Ensure that FEIBA is completely dissolved, otherwise active material will not pass through the device filter.
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 plastic injection/infusion devices should be used with FEIBA.
Use aseptic technique throughout entire procedure.
- Remove the blue cap from BAXJECT II Hi-Flow. Take the syringe and connect it to BAXJECT II Hi-Flow (DO NOT DRAW AIR INTO THE SYRINGE) (Fig. e).
- Invert the system (with FEIBA vial on top). Draw the FEIBA solution into the syringe by pulling the plunger back slowly (Fig. f).
- Disconnect the syringe.
- Slowly inject the solution intravenously with a winged set for injection.
Do not exceed an infusion rate of 2 U FEIBA/kg/Body Weight per minute.
Do not refrigerate after reconstitution!
After complete reconstitution of FEIBA NF its injection or infusion should be commenced as promptly as practicable, but must be completed within three hours following reconstitution.
Reporting suspected side effects
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345
toll-free fax 866-678-6789
By email: email@example.com
By regular mail: National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
This document plus the full product monograph, prepared for health professionals can be found at:http://www.website.document
or by contacting the sponsor, Baxter Corporation,