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
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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
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Indications
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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
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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)
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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
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Pre-Administration Testing Requirements
| - As directed by most responsible physician, in consultation wtih a Hematologist
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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
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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
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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)
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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
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Nursing Implications
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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
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Comments
| - Contact the Saskatchewan Bleeding Disorder Program for further education and administration assistance at (306)381-4185, Monday to Friday, 0800-1630
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