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Pathology and Laboratory Medicine
Product Catalogue

​BeneFIX®

Transfusion Medicine

​Class:
Factor XI concentrate, manufactured recombinant product
​Alternate Product Name:
  • Coagulation Factor IX (9) (recombinant), antihemophilia factor IX
​Company/Supplier:
Pfizer Canada Inc.

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


​Description
  • BeneFIX® is formulated as a sterile, nonpyrogenic, lyophilized powder preparation., It is a clear, colorless solution after reconstitution
  • BeneFIX® temporarily replaces the missing coagulation factor IX needed for effective hemostasis in congenital hemophilia B patients​
​Availability
  • Vial sizes/dosages:
    • 250,​ 500, 1000, 1500, 2000 and 3000 units per vial and each strength is supplied with one pre-filled syringe of 5 mL (sterile 0.214% sodium chloride) diluent
  • Supplied by Canadian Blood Services (CBS)
  • Contact your local laboratory/transfusion laboratory service regarding in house stock availability at your site
​Indications
  • For the control and prevention of hemorrhagic episodes and for routine prophylaxis in patients with hemophilia B (congenital factor IX (9) deficiency or Christmas disease), including control and prevention of bleeding in surgical settings
  • 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
  • Treatment of other factor deficiencies (e.g., factors II (2), VII (7) and X(10)).
  • Treatment of hemophilia A patients with or without inhibitors to factor VIII (8)
  • Reversal of Coumadin-induced anticoagulation
  • Treatment of bleeding due to low levels of liver dependent coagulation factors
  • Known anaphylactic or severe systemic reactions to human plasma-derived products or to any components in BeneFIX®
  • For a complete listing, see the contraindications section of the product monograph
​Warnings
  • Caution should be exercised in factor IX (9) deficient patients with liver disease, post-operative patients, neonates, and to patients at risk of developing thromboembolic phenomena or DIC due to the potential risk of thromboembolic complications
  • 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
  • Development of factor IX (9) neutralizing antibodies (inhibitors) may occur. If expected plasma factor IX (9) activity levels are not attained, or if bleeding is not controlled with an appropriate dose, an assay that measures factor IX (9) inhibitor concentration should be performed. A physician experienced in the care of bleeding disorder patients should be consulted in the case of a suspected factor IX (9) inhibitor​
​Dosage
  • Should be determined by a physician experienced in the care of bleeding disorder​ patients
  • For further information about dosage please review the product monograph
  • Individual dosing may vary based on body weight, laboratory values, clinical response and pharmacokinetics in patients
  • Consult with Hematologist or the Saskatchewan Bleeding Disorder Program for safe dosing recommendations by paging through switchboard (306)655-1000
​Pre-Administration Testing Requirements
​Ordering
  • Specify type of coagulation concentrate and dosage required
  • Off label requests for anyone other than bleeding disorders patients must be approved by the Transfusion Medicine Physician, available through RUH Switchboard (306)655-1000
  • To request product from the transfusion medicine laboratory, use the Plasma Protein Product Request Form #103221​
​Forms Required
  • 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)
  • Forms can be located in the Lab Services Manual or Forms on Demand​
​Supplies Required
  • Each carton of BeneFIX® includes the following:
    • A single-use BeneFIX® vial
    • One pre-filled syringe of solvent (5 mL) with one plunger rod
    • One sterile vial adapter reconstitution device (can use if no IV access already in place)
    • One sterile infusion set
    • Two (2) alcohol swabs
    • One Band-Aid
    • One gauze pad​
  • Additional supplies needed:
    • One luer lock syringe (appropriate size based on volume) for administration
​Administration
  • Blood consent: is NOT required as BeneFIX® is NOT manufactured from human plasma
  • 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 rate of administration for the entire dose should be determined by the patient's comfort level which typically would be over a period of less than or equal to 5 minutes (maximum infusion rate 10 mL per min)

  • 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 BeneFIX®. No other drugs/solutions (including normal saline) can be co-administered in the same line while BeneFIX 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 BeneFIX®
​Allow the vials of BeneFIX® and the pre-filled diluent to reach room temperature before use. This can be done by warming of both unopened vials in your hands to a comfortable temperature 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 plastic flip-top cap from the BeneFIX® vial to expose the central portions of the rubber stopper. Wipe the tope of the vial with the alcohol swab provided, or use another antiseptic solution, and allow to dry. After cleaning, do not touch the rubber stopper with your hand or allow it to touch any surface

​Peel back the cover from the clear plastic vial adaptor package. Do not remove the adaptor from the package (fig. a)
BeneFIX fig A.giffig a
​Place the vial on a flat surface. While holding the adaptor in the package, place the vial adaptor over the vial (fig. b). Press down firmly on the package until the adaptor snaps into place on top of the vial, with the adaptor spike penetrating the vial stopper. Leave the adaptor package in place
BeneFIX fig B.giffig b
​Grasp the plunger rod as shown in the diagram (fig. c). Avoid contact with the shaft of the plunger rod. Attach the threaded end of the plunger rod to the diluent syringe plunger by pushing and turning firmly
BeneFIX fig C.giffig c
​Remove the tamper-resistant, plastic-tip cap from the diluent syringe by bending the cap up and down to break the perforation. (fig. d) do not touch the inside of the cap or the syringe tip. The cap may need to be replaced, so place the cap on its side on a clean surface in a spot where it would be least likely to become environmentally contaminated.
BeneFIX fig D.giffig d
​Lift the package away from the adaptor and discard the package (fig. e)
BeneFIX fig E.giffig e
​With the vial on a flat surface, connect the diluent syringe to the vial adaptor by inserting the tip of the syringe clockwise until the connection is secured (fig. f)
BeneFIX fig f.giffig f
​Slowly depress the plunger rod to inject all the diluent into the BeneFIX® vial (fig. g)
BeneFIX fig G.giffig g
​With the syringe still connected to the adaptor, gently swirl the contents of the vial until the powder is dissolved.
​Inspect the final solution for specks before administration. The solution should appear clear and colorless
​Since the glass diluent syringes are not compatible with the needless system (tip too short to activate system), remove the diluent syringe from the vial adaptor, leaving the vial adaptor attached to the vial. Quickly attach a separate luer lock syringe and draw back the reconstituted contents (fig. h)
BeneFIX fig h.giffig h
​Detach the syringe from the vial adaptor by gently pulling and turning the syringe counter-clockwise
  • Lab testing post administration: As directed by most responsible healthcare practitioner (MRHP)
​Nursing Implications
​Adverse Events
​Comments
  • Can contact the Saskatchewan Bleeding Disorders Program for 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-1023 v1

Last Modified: Wednesday, May 13, 2020 |
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