PatientsVisitorsLocations & ServicesAbout the RegionJoin Our TeamPhysicians
Find:  Locations | Services
Pathology and Laboratory Medicine HomeTest and Services CatalogueTransfusion Medicine Product CataloguePolicy and ProcedureJob AidsSpecimen Collection and TransportRequisitionsAntibiogramsGenetic Testing and Molecular GeneticsMicrobiology EssentialsTransfusion EssentialsReference RangesLaboratory SuppliesAcute Care SCM GuidelinesContact InformationPhysician Access to Patient ResultsNew Clinic or Provider Information Changes
Pathology and Laboratory Medicine
Product Catalogue

​Tretten®

Transfusion Medicine

Class:
Factor XIII (13) A-Subunit
​Alternate Product Name:
Factor XIII (13) Concentrate, Recombinant
​Company/Supplier:
Novo Nordisk 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 recombinant, human FXIII (13)-A2 homodimers composed of two FXIII (13) A-subunits. It is structurally identical to human FXIII (13) A-subunit [A2]
  • Manufactured as a soluble protein in yeast (Saccharomyces cerevisiae) product strain containing the episomal expression vector, pD16. It is subsequently isolated by homogenization of cells and purification by several chromatography steps. No animal derived or human proteins are used in the manufacturing process​
Availability
  • Vial sizes/dosages:
    • 2500 units per vial (15 mg per vial) reconstituted with single vial 3.2 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 prophylaxis for bleeding in adult and pediatric patients with congenital Factor XIII A-subunit 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 who are hypersensitive to this drug or to any ingredient in the formulation or component of the container
  • Should not be used for prophylactic treatment of bleeding in patients with congenital factor XIII (13) B-subunit deficiency
  • For a complete listing, see the contraindications section of product monograph​
Warnings
Dosage
  • Dosage should be determined by a physician experienced in the care of rare bleeding disorder patients
  • For further information about dosage please review the product monograph
  • Individual dosing may vary 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 int he case of a suspected factor XIII (13) inhibitor
  • As directed by most responsible healthcare practitioner (MRHP)​
Ordering
  • Requests for anyone other than bleeding disorders 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
  • ​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
  • The product package contains:
    • One vial white powder for solution for injection containing 2500 units (15 mg) catridecacog.
    • One vial solvent (sterile water for injection) for reconstitution containing 3.2 mL
    • One sterile vial adapter for reconstitution
  • 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 NOT required as Tretten® 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:
    Administer the entire dose by slow intravenous injection at a rate not exceeding 1-2 mL 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 Tretten®. No other drugs/solutions (including normal saline) can be co-administered in the same line while Tretten® 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 Tretten®
Allow the vials of Tretten® 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 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 caps from the two vials. If the caps are loose or missing, do not use the vials. Clean the rubber stoppers on the vials with alcohol swabs and allow them to dry prior to use. Do not touch the rubber stoppers after wiping them

​Remove the protective paper from the vial adapter, without taking the vial adapter out of the protective cap. If the protective paper is not fully sealed or if it is broken, do not use the vial adapter. Place the solvent vial on a flat and solid surface and attach the vial adapter. Place the solvent vial on a flat and solid surface and attach the vial adapter to the solvent vial (sterile water for injection). Take care not to touch the spike on the vial adapter
Tretten Fig 1.gif
​Once attached, remove the protective cap from the vial adapter by lightly squeezing the protective cap with your thumb and index finger
Tretten Fig 2.gif
​Pull the plunger to draw in a volume of air that is equal to the amount of solvent in the solvent vial (3.2 mL sterile water
Tretten Fig 3.gif
​Screw the syringe tightly onto the vial adapter on the solvent vial. Inject air into the vial by pushing the plunger until you feel a clear resistance
Tretten Fig 4.gif
​Hold the syringe with the solvent vial upside down. Pull the plunger to draw the solvent into the syringe
Tretten Fig 5.gif
​Remove the empty solvent vial by tipping the syringe with the attached vial adapter
Tretten Fig 6.gif
​Click the vial adapter, still attached to the syringe onto the powder vial. Hold the syringe slightly tilted with the vial facing downwards. Push the plunger slowly to inject the solvent into the powder vial. Make sure not to aim the stream of solvent directly at the powder as this will cause foaming
Tretten Fig 7.gif
Gently swirl the vial until all the powder is dissolved. do not shake the vial as this will cause foaming. Check the solution for bits and discoloration. If you notice either, do not use it. The reconstituted product is a clear colorless solution.
If you need a larger dose, repeat the procedure in a separate syringe until you have reached your required dose
Tretten Fig 8.gif

  • Lab testing post administration: As directed by most responsible healthcare practitioner (MRHP)
Nursing Implications
​Adverse Events
  • Allergic reactions are possible with administration of blood components and plasma protein products ranging from mild to life threatening
  • Refer to Policies and Procedures of Blood Components and Plasma Protein Products - Administration of # 1141 for managing of allergic transfusion reaction and call MRHP
  • Document adverse event on Saskatchewan Transfusion Adverse Events Report Form # 103695, whether or not the transfusion was discontinued​
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-1012 v1

Last Modified: Wednesday, April 22, 2020 |
Questions or feedback about this page?