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Product Catalogue

​KOVALTRY®

Transfusion Medicine

Class:
Factor VIII Concentrate (Recombinant)
Alternate Product Name:
Antihemophilic Factor (Recombinant)
Company/Supplier:
Bayer Inc.
Routes
Intravenous
Other

​Direct IV

Intermittent 

IV Infusion​

​Continuous

Infusion

​Subcutaneous

Intramuscular​

Other​

​Acceptable Routes
​Yes
​No
No​
No​No​
N/A​


Description
  • KOVALTRY® is a recombinant, full length, unmodified, Factor VIII concentrate that is sterile, stable over the shelf life of the product, purified, and nonpyrogenic
  • It is produced by genetically engineered Baby Hamster Kidney (BHK) cells into which the human Factor VIII gene has been introduced together with the human heat shock protein 70 (HSP70) gene​
Availability
  • Vial sizes/dosages:
    • 250 units, 500 units and 1000 units per vial are supplied with a prefilled diluent syringe containing 2.5 mL of sterile water for injection
    • 2000  units and 3000 units per vial are supplied with a prefilled diluent syringe containing 5 mL of sterile water for injection
  • Supplied by Canadian Blood Services (CBS)
  • Contact your local laboratory/transfusion laboratory service regarding in house stock availability at your site​
Indications
  • Is indicated in adults and pediatrics with hemophilia A (congenital factor VIII deficiency) for:
    • Routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes
    • Control and prevention of episodic bleeding
    • Peri-operative management (surgical prophylaxis)
  • 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 do not have hemophilia A (factor VIII (8) deficiency)
  • Known hypersensitivity to mouse or hamster protein
  • Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container
  • For a complete listing, see the contraindications section of 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 factor VIII (8) neutralizing antibodies (inhibitors) may occur. If expected plasma factor VIII (8) activity levels are not attained, or if bleeding is not controlled with an appropriate dose, an assay that measures factor VIII (8) 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 VIII (8) inhibitor
Dosage
  • 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 at (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 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 an 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 KOVALTRY® includes the following:
    • A single-use vial of Kovaltry® lyophilized powder
    • A prefilled diluent syringe containing sterile water for injection
    • A vial adaptor (transfer device)
    • One butterfly infusion set (can use if patient does not have an IV in place)
  • Additional supplies needed:
    • One luer lock syringe (appropriate size based on volume) for administration
    • Sterile alcohol swabs (for cleaning the tops of the vials)​
Administration
  • Blood consent: Is NOT required as KOVALTRY® 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 should be determined by the patient's comfort level, which is over several minutes (typically the total dose is administered over about 5 minutes)

  • 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 KOVALTRY®. No other drugs/solutions (including normal saline) can be co-administered in the same line while KOVALTRY® 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 KOVALTRY®
​Allow the vials of KOVALTRY® 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 protective cap from the vial (A). Aseptically cleanse the rubber stopper with alcohol being careful not to handle the rubber stopper
Kovaltry Figure A.gif
​Place product vial on a firm, non-skid surface. Peel off the paper cover on the vial adapter plastic housing. Do not remove the adapter from the plastic housing. Holding the adapter housing, place over the product vial and firmly press down (B). The adapter will snap over the vial cap. do not remove the adapter housing at this step
Kovaltry Figure B.gif
​Holding the syringe by the barrel, snap the syringe cap off the tip (C). Do not touch the syringe tip with your hand or any surface. Set the syringe aside for further use.
Kovaltry Figure C.gif
​Now remove and discard the adapter plastic housing (D)
Kovaltry Figure D.gif
​Attach the prefilled syringe to the vial adapter thread by turning clockwise (E)
Kovaltry Figure E.gif
​Remove the clear plastic plunger rod from the carton. Grasp the plunger rod by the top plate. Avoid touching the sides and threads of the plunger rod. Attach the plunger rod by turning it clockwise into the threaded rubber stopper of the prefilled syringe (F)
Kovaltry Figure F.gif
​Inject the diluent slowly by pushing down on the plunger rod (G)
Kovaltry Figure G.gif
​Swirl dial gently until all powder on all sides of the vial is dissolved (H). Do not shake vial. Be sure that all powder is completely dissolved. Do not use if solution contains visible particles or is cloudy
Kovaltry Figure H.gif
​Since the glass diluent syringes are not compatible with our needless system (tip too short to activate system), remove the diluent syringe from the vial adapter, leaving the vial adapter attached to the vial. Quickly attach a separate luer lock syringe which is filled with 5 mL of air. Push down on the plunger to push all air back into the vial. Then while holding the plunger down, turn the vial with syringe upside-down (invert) so the vial is now above the syringe
Kovaltry Figure I.gif
​Draw back the reconstituted contents into the syringe by pulling the plunger rod back slowly and smoothly (j). Tilt the vial to the side and back to make sure all the solution has been drawn toward the large opening in the rubber stopper and into the syringe
Kovaltry Figure J.gif
​Detach the syringe from the vial adapter 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-1016 v1

Last Modified: Monday, April 27, 2020 |
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