Description
| - Xyntha® is a sterile, lyophilized concentrate of recombinant Factor VIII (8)
- Xyntha® is prepared by a modified process that eliminates any exogenous human - or animal derived protein in the cell culture process, purification, or final formulation
|
Availability
| - Vial sizes/dosages:
- Note: there are 2 different mixing devices available Xyntha® (vial) or Xyntha® Solofuse™ (pre-filled syringe)
- Xyntha® (vial) 250 units, 500 units, 1000 units and 2000 units are supplied with a prefilled diluent syringe containing 4 mL of sodium chloride for reconstitution
- Xyntha® Solofuse™ (pre-filled syringe) 25 units, 500 units, 1000 units, 2000 units and 3000 units and 4 mL 0.9% Sodium Chloride solution for reconstitution in a prefilled dual-chamber syringe
- Supplied by Canadian Blood Services (CBS)
- Contact your local laboratory/transfusion laboratory service regarding in house stock availability for your site
|
Indications
| - For the control and prevention of hemorrhagic episodes and for routine and surgical prophylaxis in patients with hemophilia A (congenital factor VIII (8) deficiency or classic hemophilia)
- 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)
- 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 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 Request Form # 103221
|
Forms Required
| - Plasma Protein Product Request Form # 103221
- Transfusion/Infusion Administration and Assessment Record # 101059
- Saskatchewan Transfusion Adverse Even Report Form # 103695 (only needed if adverse event occurs)
- Forms can be located in the Lab Services Manual of Forms on Demand
|
Supplies Required
| - Supplies: Each carton of Xyntha® Vial Kit includes the following:
- A single-use vial of Xyntha® lyophilized powder
- A prefilled diluent syringe containing sodium chloride for injection
- A vial adaptor
- One butterfly infusion set (can use if patient does not have an IV in place)
- Two alcohol swabs
- One gauze
- One Bandaid
- Additional Supplies Needed:
- One luer lock syringe (appropriate size based on volume) for administration
- Supplies: Each carton of Xyntha®Solofuse™ includes the following;
- A single-use prefilled dial-chamber syringe of Xyntha® lyophilized powder and 4 mL of 0.9% sodium chloride
- One plunger rod for assembly
- One butterfly infusion set (can use if patient does not have an IV in place)
- Two alcohol swabs
- One vented sterile cap
- One gauze
- One Bandaid™
- Additional supplies that may be needed:
- One luer lock syringe (appropriate size based on volume) for administration
|
Administration
| - Blood consent: Is NOT required as Xyntha® 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:
At a rate of 4 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 Xyntha®. No other drugs/solutions (including normal saline) can be co-administered in the same line while Xyntha® 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
- Xyntha® Vial Kit
Use aseptic technique (clean and germ free) when preparing and reconstituting Xyntha
Allow the vials of Xyntha® and the prefilled 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 flip-top cap from the Xyntha® vial to expose the central portions of the rubber stopper
| 
| wipe the top of the vial with an alcohol swab. Allow the alcohol to dry
|
| Peel back the paper cover from the vial adapter package. Do not remove the adapter from the package
| 
| Place the vial on a flat surface. While holding the adapter in the package, place the vial adapter over the vial. Press down firmly on the package until the adapter snaps into place on top of the vial, with the adapter spike penetrating the vial stopper
| 
| Peel back the paper cover from the prefilled syringe package. Take the plunger rod at the end and avoid contact with the shaft. Attach the threaded end of the plunger rod to the solvent syringe plunger. Turn the plunger rod clockwise until a slight resistance is felt.
| 
| Break off the tamper-proof plastic tip from the solvent syringe by snapping the perforation of the cap. This is done by bending the cap up and down until the perforation is broken. Do not touch the inside of the cap or the syringe tip
| 
| Lift the package away from the adapter and discard the package
| 
| Place the vial on a flat surface. Connect the diluent syringe to the vial adapter by inserting the tip of the syringe into the adapter opening while firmly pushing and turning the syringe clockwise until the connection is secured
| 
| Slowly depress the plunger rod to inject all the diluent into the Xyntha® vial. With the syringe still connected to the adapter, gently swirl the contents of the vial until the powder is dissolved. DO NOT SHAKE. Wait until all the powder dissolves completely. Inspect the final solution for particles before administration. The solution should be clear and colorless, practically free from visible particles
| 
| 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
|
| Turn the vial attached to the syringe upside down, and slowly draw the final solution into the syringe. Make sure that the entire content of the vial is transferred to the syringe
| 
|
Use aseptic technique (clean and germ free) when preparing and reconstituting Xyntha Solofuse™
Allow the prefilled dual-chamber syringe of freeze-dried Xyntha® to reach room temperature. 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 contents of the Xyntha® Solofuse™ Kit and place on a clean surface, making sure you have all the supplies you need
|
| Grasp the plunger rod as shown in the following diagram. Avoid contact with the shaft of the plunger rod. screw the plunger rod. Screw the plunger rod firmly into the opening in the finger rest of the Xyntha® Solofuse™ by pushing and turning firmly until resistance is felt (approximately 2 turns)
| 
| Holding the Xyntha Solofuse™ upright, remove the white tamper-evident seal by bending the seal right to left (or a gentle rocking motion) to break the perforation of the cap and expose the grey rubber tip cap of the Xyntha® Solofuse™
| 
| Remove the protective blue vented sterile cap from its package. While holding the Xyntha® Solofuse™ upright, remove the grey rubber tip cap and replace it with the protective blue vented cap (prevents pressure build-up). Avoid touching the open end of both the syringe and the protective blue vented cap
| 
| Gently and slowly advance the plunger rod by pushing until the two stoppers inside the Xyntha® Solofuse™ meet, and all of the diluent is transferred to the chamber containing the xyntha® powder. Note: To prevent the escape of fluid from the tip of the syringe, the plunger rod should not be pushed with excessive force
| 
| With the Xyntha® Solofuse™ remaining upright, swirl gently several times until the powder is dissolved.
| 
| Again holding the Xyntha® Solofuse™ in an upright position, slowly advance the plunger rod until most, but not all, of the air is removed from the drug product chamber
| 
|
- Lab testing post administration: As directed by the most responsible physician (MRP)
|
Nursing Implications
| - Patient monitoring: Follow the Nursing Policy and procedure Blood Components and Plasma Protein Product - Administration of # 1141
- Documentation: Administration and vital signs shall be recorded on the Transfusion/Infusion Administration and Assessment Record # 101059
|
Adverse Events
| - Allergic reactions are possible with administration of blood components and plasma protein products ranging from mild to life threatening
- Refer to Nursing Policy and Procedure Blood Components and Plasma Protein Product - Administration of #1141 for managing of allergic transfusion reaction and call MRP
- Document adverse event on Saskatchewan Transfusion Adverse Event 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
|
