Consumer medicine information

1. Why am I using FEIBA NF?

FEIBA NF contains the active ingredient factor VIII inhibitor bypassing fraction. FEIBA NF is used to treat and prevent bleeding in patients with haemophilia A and B who have developed inhibitors (antibodies) against coagulation factor VIII and factor IX, respectively. For more information, see Section 1. Why am I using FEIBA NF? in the full CMI.

2. What should I know before I use FEIBA NF?

Do not use if you are allergic to FEIBA NF or any of the ingredients listed at the end of the CMI. Do not use if you are suffering from a blood clotting condition called Disseminated Intravascular Coagulation. Talk to your doctor if you have or have had any other medical conditions, if you take any other medicines, if you are pregnant or plan to become pregnant or if you are breastfeeding or plan to breastfeed. If you are taking a medicine called emicizumab, it is very important you talk to your doctor before using FEIBA NF. For more information, see Section 2. What should I know before I use FEIBA NF? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with FEIBA NF and how it works. Tell your doctor or Haemophilia Treatment Centre if you are taking or using any other medicines including any that you get without a prescription from your pharmacy, supermarket, or health food shop. For more information, see Section 3. What if I am taking other medicines? in the full CMI.

4. How will I be given FEIBA NF?

• FEIBA NF injection is prepared and administered by a qualified healthcare professional who is experienced in the care of patients with haemophilia.

• Your dose of FEIBA NF is dependent on your condition and body weight, and your dose may change during treatment.

• The frequency of your infusions will depend on how well FEIBA NF is working for you.

• FEIBA NF is given slowly by injection directly into your veins.

• FEIBA NF is supplied as a dry powder and the powder must be dissolved with the diluent supplied in the pack before use.

5. What should I know while using FEIBA NF?

6. Are there any side effects?

Common side effects include headache, dizziness, light-headedness, rash, allergies, hepatitis B surface antibody positive. Serious side effects include a condition called disseminated intravascular coagulation, blood clots in the veins or lungs, heart attack, stroke, severe sudden allergic reaction which may progress to difficulty in breathing, chest pain and fainting. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Factor VIII inhibitor bypassing fraction.

2 Qualitative and Quantitative Composition

Description. Feiba NF is a sterile lyophilised powder containing a complex of coagulation Factors. It is intended for intravenous administration after reconstitution.
The potency of Feiba NF is expressed in arbitrary units of factor VIII bypassing activity. One Unit of activity is defined as that amount of Feiba NF that shortens the activated partial thromboplastin time (aPTT) 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. In addition, 1-6 units of Factor VIII coagulation antigen (FVIII C: Ag) per mL are present.
Feiba NF is prepared from pooled human plasma. During manufacture, the product 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 as contained in human plasma protein.
Following reconstitution with the diluent vial provided, the Feiba activity in each vial is: 50 Feiba units/mL (2500 U/50 mL, 1000 U/20 mL and 500 U/10 mL) or 25 Feiba units/mL (500 U/20 mL).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder and diluent for injection.
Appearance. Feiba NF is formulated as a sterile, nonpyrogenic, off-white, lyophilised powder, for intravenous injection. It is supplied in single-dose glass vials.
Each Feiba NF 500 U pack contains: 1 powder vial of 500 Feiba-units as contained in 200-600 mg human plasma protein, 1 diluent vial of either 10 mL or 20 mL water for injections, 1 Baxject II Hi-Flow - Needleless transfer device intended for transferring and mixing drugs contained in two vials into a syringe.
Each Feiba NF 1000 U pack contains: 1 powder vial of 1000 Feiba-units as contained in 400-1200 mg human plasma protein, 1 diluent vial of 20 mL water for injections, 1 Baxject II Hi-Flow - Needleless transfer device intended for transferring and mixing drugs contained in two vials into a syringe.
Each Feiba NF 2500 U pack contains: 1 powder vial of 2500 Feiba-units as contained in 1000-3000 mg human plasma protein, 1 diluent vial of 50 mL water for injections, 1 Baxject II Hi-Flow - Needleless transfer device intended for transferring and mixing drugs contained in two vials into a syringe.

4 Clinical Particulars

4.9 Overdose

Some reported thromboembolic events have occurred with doses above 200 U/kg.
If signs and symptoms of thromboembolic events are observed, the infusion should be stopped immediately, and appropriate diagnostic and therapeutic measures initiated.
For information on the management of overdose, contact the Poisons Information Centre telephone: 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No genotoxicity was observed using a bacterial reversion assay (Ames test).
Carcinogenicity. No carcinogenicity studies have been performed with Feiba NF.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Feiba NF contains Factors II, IX and X, mainly non-activated, and Factor VII mainly in the activated form. In addition, 1-6 units of Factor VIII coagulation antigen (FVIII C: Ag) per mL are present.
CAS number. Not available.

7 Medicine Schedule (Poisons Standard)

Unscheduled (Exempted).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/FEIBANST.gif

References

¹ Australian approved Product Information for emicizumab.
² Oldenburg J., Mahlangu J., Kim B., Schmitt C., et al, "Emicizumab Prophylaxis in Hemophilia A with Inhibitors", N Engl J Med (2017), 377, 809-818.
³ Sjamsoedin L.J.M., Heijnen L., Mauser-Bunschoten E.P. et al, "The Effect of Activated Prothrombin-Complex Concentrate (Feiba) on joint and muscle bleeding in patients with haemophilia A and antibodies to Factor VIII", New England J. Med. (1981), 305, 717-721.
⁴ Hilgartner M.W, Knatterud G.L., "Feiba Study Group, The use of Factor Eight Inhibitor By-Passing Activity (Feiba Immuno) Product for treatment of bleeding episodes in haemophiliacs with inhibitors", Blood, (1983), 61, 36-40.
⁵ Hilgartner M., Aledort L., Andes A., Gill J., The Members of the Feiba Study Group: "Efficacy and safety of vapour-heated anti-inhibitor coagulant complex in haemophilia patients", Transfusion, (1990), 30, 626-630.