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Product Catalogue

​ADYNOVATE

Transfusion Medicine

Class:
Factor VIII extended half-life  (EHL) concentrate
Alternate Product Name:
  • Antihemophilic Factor (Recombinant), PEGylated, Factor VIII EHL, Long Acting Factor
​Company/Supplier:
Shire Pharma Canada Inc./Takeda
Routes
Intravenous
Other
​Direct IV
Intermittent
IV Infusion​
​Continuous
Infusion
​Subcutaneous
​Intramuscular
Other​
Acceptable Routes
Yes​
​No
​No
​No
​No
​N/A


Description
  • ADYNOVATE Antihemophilic Factor (Recombinant, PEGylated, is formulated as a sterile non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection
  • ADYNOVATE temporarily replaces the missing coagulation factor VIII (8) needed for effective hemostasis in congenital hemophilia A patients. ADYNOVATE exhibits an extended terminal half life through PEGylating of the parent molecule, ADVATE, which reduces binding to the physiological factor VIII clearance receptor​
Availability
  • Vial sizes/dosages:
    • 250 units, 500 units, 1000 units, 2000 units per vial. ​Each strength is supplied with 5 mL sterile water for injection (USP, Ph. Eur.) for reconstitution
  • Supplied by Canadian Blood Services (CBS)
  • Contact your local laboratory/transfusion laboratory service regarding in house stock availability at your site
​Indications
  • Indicated in adults and pediatrics with hemophilia A (congenital factor VIII () deficiency) for:
    • Control and prevention of bleeding episodes
    • Prophylaxis to prevent or reduce the frequency of bleeding episodes
    • Perioperative management
  • 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)
  • Prior anaphylactic reaction to ADYNOVATE, the parent molecule (ADVATE), mouse or hamster protein, or exipients of ADYNOVATE (Tris, calcium chloride, mannitol, sodium chloride, trehalose, glutathione, histidine, and/or polysorbate 80)
  • For 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 approproate 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 a 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 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
  • 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 ADYNOVATE includes the following:
    • A single-use vial of ADYNOVATE lyophilized powder
    • A vial of 5 mL sterile water as diluent for reconstitution
    • A needle-less filter transfer device Baxject II Hi-Flow reconstitution device
  • A separate carton containing the following is also provided along with the product carton:​
    • One butterfly infusion set (can use if patient does not have an IV in place)
    • 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 ADYNOVATE 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 of ADYNOVATE over a period of less than or equal to 5 minutes (maximum infusion rate 10 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 ADYNOVATE. No other drugs/solutions (inclduing normal saline) can be co-adminsitered in the same line while ADYNOVATE 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 ADYNOVATE
Allow the vials of ADYNOVATE and diluent to reach room temperature before use. This can be done by warming of both unopened vials in your hands to a comfortable temerpature or by leaving the unopened dvials at room temperature for about 30 minutes prior to administration. Warming of the vials will ease with dissolving the powder and lessen patient discomfort in the vein when administering

​Remove plastic caps from the ADYNOVATE and diluent vials

​Cleanse rubber stoppers with an alcohol wipe and allow drying prior to use

​Open the BAXJECT II Hi-Flow device package by peeling away the lid without touching the inside (figure A). Do not remove the device from the package
Adynovate fig A.gif
​Turn the package over. Press stright down to fully insert the clear plastic spike through the diluent vial stopper (figure B)
Adynovate fig B.gif
​Grip the BAXJECT II Hi-Flow package at its edge and pull the package off the device (figure C). Do not remove the blue cap from the BAXJECT II Hi-Flow device. Do not touch the exposed purple plastic spike
Adynovate fig C.gif
​Turn the system over so that the diluent vial is on top. Quickly insert the purple plastic spike fully into the ADYNOVATE vial stopper by pushing straight down (figure D). The vacuum will draw the diluent into the ADYNOVATE vial.
Adynovate fig D.gif
​Swirl gently until ADYNOVATE is completely dissolved

​Remove the blue cap from the BAXJECT II Hi-Flow device. Connect the syringe to the BAXJECT II Hi-Flow Device (Figure E). Use of a Luer-lock syringe is recommended. Do not inject air
Adynovate fig E.gif
​Turn the system upside down (ADYNOVATE vial is now on top). Draw the factor concentrate into the syringe by pulling the plunger back slowly (figure F)
Adynovate fig F.gif
​Disconnect the syringe. If a patient is to receive more than one vial of ADYNOVATE, the contents of multiple vials may be drawn into the same syringe. A Baxject II Hi-Flow device is required to reconstitute each vial of ADYNOVATE and diluent needed

  • Lab testing post administration: As directed by most responsible healthcare practitioner (MRHP)
​Nursing Implications
Adverse Events
Comments
  • Contact the Saskatchewan Bleeding Disorders Program for further 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-1015 v1

Last Modified: Thursday, April 23, 2020 |
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