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Product Catalogue

​FEIBA NF®

Transfusion Medicine

​Class:
Human plasma fraction with factor VIII inhibitor bypassing agent
​Alternate Product Name:
Human Plasma Fraction with Factor VIII Inhibitor Bypassing Agent
​Company/Supplier:
Shire Pharma Canada Inc./Takeda

Routes​
​Intravenous
​Other
​Direct IV
Intermittent
IV Infusion​
Continuous
Infusion​
​Subcutaneous
Intramuscular​
Other​
​Acceptable Routes
​Yes
​Yes
​No
​No
​No
​N/A


​Description
  • Anti-Inhibitor Coagulant Complex, Vapor Heated and Nano filtered FEIBA NF®, is a freeze-dried sterile human pasma fraction with Factor VIII inhibitor bypassing activity
  • FEIBA NF® (Factor Eight Inhibitor Bypassing Agent) contains Factors II (2), IX (9), and X (10), mainly non-activated, and Factor VII (&) mainly in the activated form
  • FEIBA NF® has been prepared from source plasma and/or fresh frozen plasma. Individual donations of human plasma are combined to form plasma pools​
​Availability
  • Vial sizes/dosages:
    • 1000 units reconstituted with 20 mL of sterile water (diluent)
    • 2500 units reconstituted with 50 mL of sterile water (diluent)
  • Supplied by Canadian Blood Services (CBS)
  • Contact your local laboratory/transfusion laboratory service regarding in house stock availability at your site​
​Indications
  • FEIBA NF® (Anti-Inhibitor Coagulant Complex) is indicated for use in congenital Hemophilia A and B patients wtih inhibitors for:
    • Control of spontaneous bleeding episodes
    • Surgical interventions
    • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children older than 6 years of age
  • FEBA NF® may be used for treating non-haemophiliacs with acquired in hibitors to factors VIII (8), XI (11) and XII (12) in case of life-threatening haemorrhages
  • Off-label indication: Management of bleeding in the setting of direct thrombin inhibitor dabigatran (Pradaxa) when the reversal agent idaracizumab (praxbind) is unavailable

  • Treatment should be initiated and supervised by a healthcare practitioner experienced in the use of coagulation agents and in the management of bleeding disorders​
​Contraindications
  • Patients who are known to have a normal coagulation mechanism
  • Patients wtih known hypersensitivity to the product
  • Patients with significant signs of disseminated intravascular coagulation (DIC) or fibrinolysis
  • Patients with known anaphylactic or sever systemic reactions to human plasma-derived products or to any components in FEIBA NF®
  • For a complete listing, see the contraindications section of the product monograph​
​Warnings
  • In patients with a tentative or definite diagnosis of coronary head disease and in patients with acute thrombosis and/or embolism (including myocardial infarction), the use of FEIBA NF® is only indicated in life-threatening bleeding events​
  • Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, discontinue treatment and follow adverse event protocol. See Nursing Policy and Procedure Blood Components and Plasma Protein Product - Administration of #1141
  • Thomboembolic complications have been reported in post marketing surveillance (see WARNINGS AND PRECAUTIONS AND ADVERSE EVENTS in product monograph)
​Dosage
  • Dosage should be determined by a physician experienced in the care of bleeding disorder patients
  • for further infromation about dosage please review the product monograph​
  • Individual dosing may vary based on the based-on body weight, laboratory values, and the patient's clinical condition
  • Consult with Hematologist or the Saskatchewan Bleeding Disorder Program for safe dosing recommendations by paging through switchboard at (306)655-1000
​Pre-Administration Testing Requirements
  • As directed by most responsible physician, in consultation wtih a Hematologist​
​Ordering
  • Specify type of coagulation concentrate and dosage required
  • Off label requests must be approved by the Transfusion Medicine Physician, available through switchboard at (306)655-1000
  • To request product from the transfusion medicine laboratory, use the Plasma Protein Product Requst Form #103221​
​Forms Required
  • ​Informed Consent for Blood Components and/or Plasma Protein Products #101479
  • Plasma Protein Product Request Form #103221
  • Transfusion/Infusion Administration and Assessment Record #101059
  • Saskatchewan Transfusion Adverse Event Report Form #103695 (only needed if adverse event occurs)
  • Notification of Administration of Blood and/or Blood Products Form #103854
  • Forms can be located in the Lab Services Manual or Forms on Demand
Supplies Required​
  • Each product package contains:
    • A single use vial of FEIBA NF® as freeze-dried powder
    • A single use of vial of 5 mL sterile water as diluent for reconstitution
    • A needle-less filter transfer device (Baxject II Hi-Flow) for the reconstitution and withdrawal of the product​
  • Additional supplies needed:
    • One butterfly infusion set (can use if patient does not have an IV)
    • One luer lock syringe (appropriate size based on volume) for administration
    • Alcohol swabs (for cleaning the tops of the vials)
​Administration
  • Blood consent: is required due to human plasma component
  • Pre-infusion: Ensure recent patient weight is on file and pertinent laboratory results are available
  • Perform all other appropriate pre-administration checks per protocol, detailed in the Nursing Policy and Procedure Blood Components and Plasma Protein Product - Administration of #1141​

  • Administration:
    The solution must be given by intravenous injection or intermittent intravenous infusion. Can be infused using the Plum 360 SMART IV pump; use "no drug selected" and then choose "units/kg/min" for the infusion
    The maximum injection or infusion rate must not exceed 2 units per kg of body weight per minute

  • For additional preparation/reconstitution and administration steps see administration section of the Product Monograph

  • Access: can be given via, CVC, PICC, Port-a-Cath®, or peripheral IV
  • Compatible Solutions: can flush line with 0.9% normal saline pre and post administration of FEIBA NF®. No other drugs/solutions (including normal saline) can be co-administered in the same line while FEIBA NF® is being infused

  • Preparation and Reconstitution
    NOTE: Reconstitute only immediately before administration
    • Administer within 3 hours of reconstitution
    • DO NOT refrigerate after reconstitution
    • DO NOT further dilute in any IV solutions
    • DO NOT mix with other drugs or IV solutions
Use aseptic technique (clean and germ free) when preparing and reconstituting FEIBA NF®
​Allow the vials of FEIBA NF® and diluent to reach room temperature before use. This can be done by warming of both unopened vials in your hands to a comfortable temperature (do not exceed 37°C) or by leaving the unopened vials at room temperature for about half an hour prior to administration. Warming of the vials will ease with dissolving the powder and lessen patient discomfort in the vein when administering

​Remove the protective caps from the FEIBA NF® vial and solvent vial and cleanse the rubber stoppers with a remicidal 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
FEIBA fig a.gif
​Turn the package over and insert the clear plastic spike through the solvent stopper (fig. b)
FEIBA fig b.gif
​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
FEIBA fig c.gif
​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 facuum will draw the solvent into the FEIBA NF® vial (fig. d)
FEIBA fig d.gif
​Swirl gently until all the material is dissolved. Ensure that FEIBA NF® is completely dissolved, otherwise active amterial will not pass through the device filter

​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)
FEIBA fig e.gif
​Invert the system (with FEIBA NF® vial on top). Draw the FEIBA NF® solution into the syringe by pulling the plunger back slowly (fig. f)
FEIBA fig f.gif
​Disconnect the syringe. it is ready to infuse
  • Lab testing post administration: As directed by most responsible physician (MRP)
​Nursing Implications
​Adverse Events
  • Rapid intravenous injection or infusion may cause a stabbing pain and numbness in the face and extremities as well as a drop in blood pressure
  • Allergic reactions are possible with administration of blood components and plasma protein products ranging from mild to life threatening
  • Refer to Nursing Policy and Procedure Blood Components and Plasma Protein Product - Administration of #1141 for managing of allergic transfusion reaction and call MRHP
  • Document adverse event on Saskatchewan Transfusion Adverse Event Report Form #103695, whether or not the transfusion was discontinued​
​Comments
  • Contact the Saskatchewan Bleeding Disorder Program for further education and administration assistance at (306)381-4185, Monday to Friday, 0800-1630​
​References


If you choose to print this information, it is valid only on date of print.

Laboratory Controlled Document LSM-1021 v1

Last Modified: Wednesday, May 6, 2020 |
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