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Pathology and Laboratory Medicine
Product Catalogue

​Corifact®

Transfusion Medicine

​Class:
Factor XIII (13) (FX111)
Alternate Product Name:
Factor XIII Concentrate, Human
Company/Supplier:
​CSL Behring 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
  • A purified concentrate of blood coagulation Factor XIII (13). It is derived from human plasma, presented as white lyophilized powder to be reconstituted with sterile water for injection (included in product package) for intravenous administration​
Availability
  • Vial sizes/dosages:
    • 250 units reconstituted with single vial 4 mL sterile water (diluent)
    • 1250 units with single vial 20 mL sterile water (diluent)
  • Supplied by Canadian Blood Services (CBS)
  • Special order product only. Not routinely stocked by Transfusion Medicine in Saskatoon
Indications
  • ​Indicated for routine prophylactic treatment and peri-operative management of surgical bleeding in adults and pediatric patients with congenital Factor XIII (13) deficiency
  • 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 with known anaphylactic or sever systemic reactions to human plasma-derived products or to any components in Corifact®
  • For a complete listing, see the contraindications section of the product monograph​
Warnings
  • 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 inhibitory antibodies against FXIII (13) has been detected in patients receiving Corifact®
  • Thromboembolic complications have been reported in post marketing surveillance (See WARNINGS AND PRECAUTIONS AND ADVERSE EVENTS in product monograph)
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 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
  • Monitoring the patient trough FXIII (13) activity level is recommended during treatment
  • Samples for FXIII (13) testing must be referred out to a reference laboratory for testing
  • If bleeding is not controlled with an appropriate dose, an assay that measures factor XIII (13) 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 XIII (13) inhibitor​
Ordering
  • Requests for anyone other than bleeding disorder patients 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 Request 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
  • The product package contains:
    • One single-use Corifact® vial
    • One single-use sterile water for injection vial
    • A needle-less filter transfer device called Mix2Vial for the reconstitution and withdrawal of the product
  • Additional supplies needed:
    • One luer lock syringe (appropriate size based on volume) for administration
    • Alcohol swab (for cleaning the tops of the vials)​
Administration
  • Blood consent: is required due to human plasma component
  • Pre-Infusion: Ensure recent patient weigh 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:
  • Administer the entire dose by slow intravenous injection at a rate not exceeding 4 mL per minute

  • For additional preparation/reconstitution and administration steps see the administration section of the product monograph

  • Access: Can be given vial CVC, PICC, Port-a-Cath, or peripheral IV

  • Compatible solution: can flush line with 0.9% normal saline pre and post administration of Corifact®. No other drugs/solution (including normal saline) can be co-administered in the same line while Corifact® is being infused

  • Preparation and Reconstitution
    NOTE: Reconstitute only immediately before administration
    Administer within 3 hours after 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 Corifact®
​Allow the vials of Corifact® 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 or by leaving the opened 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 with administering

​Place the Corifact® vial, diluent vial and Mix2Vial transfer set on a flat surface

​Remove Corifact® vial and diluent vial flip caps and wipe the stoppers with an antiseptic. Allow to dry prior to opening the Mix2Vial transfer set package

​Open the Mix2Vial® transfer set package by peeling away the lid (Fig. 1). To maintain sterility, leave the Mix2Vial® transfer set firmly through the center of the diluent vial stopper
Corifact Figure 1.gif
​Place the diluent vial on an even flat surface and hold the vial tightly. Grip the Mix2Vial® transfer set keeping it in the clear package and push the plastic spike of the blue end of the Mix2Vial transfer set firmly through the center of the diluent vial stopper (Fig. 2)
Corifact Figure 2.gif
​While holding the diluent vial, carefully remove the outer package from the Mix2Vial transfer set. Make sure to pull off only the clear package, not the Mix2Vial transfer set (Fig. 3)
Corifact Figure 3.gif
​Place the Corifact® vial on an even flat surface and hold the vial tight. Invert the diluent vial with the Mix2Vial® transfer set attached to it and push the plastic spike of the clear end of the Mix2Vial® firmly through the center of the stopper of the Corifact® vial (Fig. 4). The diluent will transfer into the Corifact® vial automatically
Corifact Figure 4.gif
​With the diluent and Corifact® vial still attached to the Mix2Vial transfer set, gently swirl the Corifact® vial to ensure that the Corifact® is fully dissolved (Fig. 5). Do not shake the vial
Corifact Figure 5.gif
​With one hand, grip the clear end of the Mix2Vial® transfer set and with the other hand grip the blue end of the Mix2Vial® transfer set, and unscrew counter clockwise the set into two pieces (Fig. 6)
Corifact Figure 6.gif
​Draw air into an empty, sterile syringe. With the Corifact® vial upright, screw the syringe to the Mix2Vial® transfer set. Inject air into the Corifact® vial. While keeping the syringe plunger pressed, invert the Corifact® vial and draw the solution into the syringe by pulling the plunger back slowly
Corifact Figure 7.gif
​Once the solution has been transferred into the syringe, firmly grip the barrel of the syringe (keeping the plunger facing down) and unscrew the syringe counter clockwise from the Mix2Vial® transfer set (Fig. 8). Attach the syringe to an infusion set or another suitable administration set
Corifact Figure 8.gif
​If patient is to receive more than one vial, the contents of multiple vials may be pooled into a single syringe. Use a separate unused Mix2Vial® transfer set for each product vial
  • Lab testing post administration: as directed by most responsible healthcare practitioner (MRHP)
​Nursing Implications
Adverse Events
Comments
  • Contact the Saskatchewan Bleeding Disorder 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-1019 v1

Last Modified: Wednesday, April 29, 2020 |
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