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Product Catalogue

​ALPROLIX®

Transfusion Medicine

​Class:
Factor VIII extended half-life concentrate
​Alternate Product Name:
  • Recombinant Factor IX, Fusion Protein
​Company/Supplier:
Sanofi (formerly known as Bioverativ)

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


​Description
  • ALPROLIX® (Coagulation Factor IX (Recombinant), Fc Fusion Protein) is formulated as a sterile, non-pyrogenic, preservative free, and white to off-white, lyophilized powder to cake for intravenous administration in a single use vial
  • ALPROLIX® is coagulation Factor IX made in the laboratory using recombinant technology.
​Availability
  • Vial sizes/dosages:
    • 250 units,​ 500 units, 1000 units, 2000 units and 3000 units/vial. Each strength is supplied with 5 mL prefilled syringe diluent of 0.325% sodium chloride for reconstitution
  • Supplied by Canadian Blood Services (CBS). See CBS "Factor concentrates and other plasma protein product order form" for current availability.
  • NOTE: At this time the initial ordering for this product requires submission of "Request for Patient Designated Plasma Protein Products" and medical review and approval. Form available here
  • 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
​Indications
  • ALPROLIX® (Coagulation Factor IX (Recombinant), Fc Fusion Protein) is a long-acting anti-hemophilic factor (recombinant) indicated in adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for:
    • Routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes
    • Control and prevention of bleeding episodes
    • Perioperative 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 B (factor IX (9) deficiency)
  • In individuals who have manifested severe hypersensitivity reactions, including anaphylaxis, to the product or to the components in Alprolix
  • 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 even 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.
  • The use of factor IX containing products has been associated with the development of thromboembolic complications (e.g., pulmonary embolism, venous thrombosis, and arterial thrombosis). Due to the potential risk for thromboembolic complications, monitor patients for early signs of vascular thrombotic events
​Dosage
  • Dosage of Alprolix should be determined by a physician experienced in the care of hemophilia patients
  • For further information about dosage please review the product monograph
  • Individual dosing may vary based on the clinical response/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
  • Recent validated test results (e.g., the one-stage clotting or chromogenic substrate assay) to confirm the need of coagulation factor IX (9)
  • Consider testing for the presence of inhibitors if clinically indicated
  • Preferred Collection Container: BLUE plastic (3.2% Buffered Na citrate)
  • Optimal Volume for single test: Two 2.7 mL 3.2% Buffered Na Citrate or three 1.8 mL 3.2% Buffered Na Citrate
  • As directed by most responsible healthcare practitioner (MRHP)
​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 Alprolix® includes the following:
    • A single-use Alprolix® lyophilized powder
    • A pre-filled syringe of 5 mL 0.325% sodium chloride as diluent with a plunger stopper for reconstitution
    • A sterile vial adapter reconstitution device
    • A tip-cap
  • A separate carton containing the following is also provided along with the product carton:
    • 1 infusion set (can use if patient does not have an IV in place
    • 2 sterile alcohol swabs
    • 1 gauze pad
    • 2 bandages
​Administration
  • Blood consent: is NOT required as Alprolix® 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 Alprolix over a period of less than or equal to 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 Alprolix®. No other drugs/solutions (including normal saline) can be co-administered in the same line while Alprolix 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 Alprolix®
​Allow the vials of ALPROLIX® and diluent to reach room temperature before use

Remove plastic caps from the ALPROLIX® and diluent vials

​Cleanse rubber stoppers with an alcohol wipe and allow drying prior to use. After cleaning, do not touch the rubber stopper with your hand or allow it to touch any surface
​Completely remove the backing from the vial adapter package by peeling back the lid. Do not remove the vial adapter from the package or touch the inside of the vial adapter
Alprolix image 1.jpg
​Keep the vial on a flat surface. Hold the vial adapter package with one hand and using the other hand, place the vial adapter over the vial. 
The spike should be placed directly above the center of the rubber stopper
Push the vial adapter straight down until the adapter spike punctures the center of the vial stopper and is fully inserted
Alprolix image 2.jpg
Lift the package cover away from the vial adapter and discard the cover
Alprolix image 3.jpg
​Only use the diluent syringe provided to reconstitute the drug product
Hold the plunger rod at the circular disk.
Place the tip of the plunger rod into the end of the syringe. Turn in a clockwise motion until it is securely attached
Alprolix image 4.jpg
With one hand, hold the diluent syringe right under the cap, and with the cap pointing up.
Make sure you are holding the diluent syringe by the ridged part directly under the cap
Do not use if the cap has been removed or is not securely attached
Alprolix image 5.jpg
​With your other hand, grasp the cap and bend it at a 90o angle until it snaps off
After the cap snaps off, you will see the glass tip of the syringe
Do not touch the glass tip of the syringe or inside of the cap.
Alprolix image 6.jpg
Be sure the vial is sitting on a flat surface
Insert the tip of the syringe into the adapter opening. Turn the syringe in a clockwise motion
Alprolix image 7.jpg
​Slowly depress the plunger rod to inject all of the diluent into the vial. The plunger rod may rise slightly after this process, this is normal
Alprolix image 8.jpg
With the syringe still connected to the adapter, gently swirl the vial until the product is completely dissolved
The appearance of the solution should be clear to slightly opalescent and colorless.
DO NOT Shake
DO NOT use the reconstituted ALPROLIX if it contains visible particles or is cloudy

NOTE: if you are using more than one vial, stop here and proceed to the Pooling instructions below
Alprolix image 9.jpg
​Make sure the plunger rod is completely depressed. Turn the vial upside-down. Slowly pull on the plunger rod to draw the solution into the syringe. Be careful not to pull the plunger rod completely out of the syringe
Alprolix image 10.jpg
POOLING
Is the process of combining two or more reconstituted vials into a larger syringe (not into the diluent syringe) prior to intravenous administration.
If you are using two or more vials, follow these pooling steps.
Be sure to leave the vial adapter attached to the vial as you will need it for attaching a large luer lock syringe
Do not detach the diluent syringe or the large luer syringe until you are ready to attach the large luer lock syringe to the next vial (with vial adapter attached)

​Remove the diluents syringe from the vial adapter by turning it counter clockwise until it is completely detached
Alprolix image 12.jpg
​Attach a separate large luer lock syringe by turning it clockwise until it is securely attached
Alprolix image 13.jpg
​Slowly pull on the plunger rod to draw the solution into the syringe. Repeat this pooling procedure with each vial you will be using. Once you have pooled the required dose, proceed to administration using the large luer lock syringe
Alprolix image 14.jpg

Syringe labels are not required as this product is administered intravenously over less than or equal to 5 minutes

  • Lab testing post administration: As directed by MRHP
  • NOTE: Following administration with Alprolix, a one-stage clotting assay with a silica-based aPTT reagent must be used for testing
​Nursing Implications
​Adverse Events
​Comments
  • Can contact the Saskatchewan Bleeding Disorders Program for education and administration assistance at (306)381-4185.
​References


If you choose to print this information, it is valid only on date of print.

Laboratory Controlled Document LSM-1038 v1


Last Modified: Monday, December 7, 2020 |
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