Feiba NF (Takeda Canada, 1300 Unit, 3250 Unit, 650 Unit): Uses, Side Effects and Dosage

Serious Warnings and Precautions:

What is FEIBA NF used for?

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 haemorrhages.

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, FEIBA NF

AHF = Antihemophilic Factor

Inadequate response to treatment may result from an abnormal platelet count or impaired platelet function which were present before treatment with FEIBA NF.

How does FEIBA NF work?

Factor VIII and Factor IX are proteins that help blood clot to stop bleeding. Factor VIII is missing or not working properly in people with hemophilia A. Factor IX is missing or not working properly in people with hemophilia B. FEIBA NF includes multiple proteins that make blood clot when Factor VIII or IX are missing.

What are the ingredients in FEIBA NF?

Medicinal ingredients: Anti-Inhibitor Coagulant Complex

Non-medicinal ingredients: Sodium Chloride and Trisodium Citrate

FEIBA NF comes in the following dosage forms:

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 (350-650 Units per 10 mL, 700-1300 Units per 20 mL, 1750 - 3250 Units per 50 mL).

Do not use FEIBA NF if:

• You are known to have a normal coagulation mechanism.
• You have hypersensitivity to the product.
• You have significant signs of disseminated intravascular coagulation (DIC) or fibrinolysis.
• You have a tentative or definite diagnosis of coronary heart disease.
• You have acute thrombosis and/or embolism (including myocardial infarction), the use of FEIBA NF is only indicated in life-threatening bleeding events.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take FEIBA NF. Talk about any health conditions or problems you may have, including if you:

• have liver disease
• have an active infection
• suffer from inflammation
• have been diagnosed with cancer
• have a history of chest pain or heart attack
• are on a low sodium diet

• are pregnant, planning to become pregnant, or are breastfeeding

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with FEIBA NF:

• Tranexamic acid or aminocaproic acid (medicines that block the breakdown of blood clots)
• Recombinant Factor VIIa and emicizumab (medicines that help blood to clot to prevent bleeding)

How to take FEIBA NF:

FEIBA NF will be given to you by a healthcare professional in a healthcare setting.

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.

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.

1. 1. 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).
2. 2. 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.
3. 3. 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.
4. 4. 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.
5. 5. 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 NF vial stopper. The vacuum will draw the solvent into the FEIBA vial (Fig. d).
6. 6. Swirl gently until all the material is dissolved. Ensure that FEIBA is completely dissolved, otherwise active material will not pass through the device filter.

Injection/Infusion

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.

1. 1. 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).
2. 2. Invert the system (with FEIBA vial on top). Draw the FEIBA solution into the syringe by pulling the plunger back slowly (Fig. f).
3. 3. Disconnect the syringe.
4. 4. 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. A syringe pump may be used to control the rate of administration.

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.

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.

Usual dose:

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
• Surgery

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.

Overdose:

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.

Missed dose:

No action to be taken.

What are possible side effects from using FEIBA NF?

These are not all the possible side effects you may have when taking FEIBA NF. If you experience any side effects not listed here, tell your healthcare professional.

• Hypersensitivity (allergic reaction)
• Drowsiness
• Dizziness
• Changes in taste
• Headache
• Hypotension (low blood pressure)
• Shortness of breath
• Nausea
• Rash
• Chills or fever
• Chest pain

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Serious side effects and what to do about them

Reporting Side Effects

Storage:

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, FEIBA NF is to be reconstituted only immediately before administration. The solution should then be used promptly. Any unused solution must be discarded.

Keep out of reach and sight of children.

If you want more information about FEIBA NF:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website https://takeda.info/ca-medicines, or by calling 1-800-268-2772.

Takeda Canada Inc.

22 Adelaide Street West, Suite 3800

Toronto, Ontario

M5H 4E3

Last Revised:

FEIBA^® is a registered trademark of Baxalta Incorporated. Takeda® and the Takeda Logo are trademarks of Takeda Pharmaceutical Company Limited, used under license.