Description
| - Nuwiq® is a recombinant human coagulation factor VIII (8) (rhFVIII) produced by DNA technology in genetically modified human embryonic kidney (HEK) 293F cells with no animal or human derived materials added during the manufacturing process or to the final medicinal product
- Nuwiq® is supplied as a white sterile lyophilized powder and solvent for solution for intravenous injection using the provided injection set
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Availability
| - Vial sizes/dosages:
- 250 units, 500 units, 1000 units, 2000 units, 3000 units and 4000 units per vial are supplied with a prefilled diluent syringe containing 2.5 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
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Indications
| - Treatment and prophylaxis of bleeding in patients of all ages suffering with hemophilia A (congenital factor VIII (8) 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
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Contraindications
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Warnings
| - Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, discontinue treatment and follow adverse event protocol. See Nursing Policy and Procedure of 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
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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, available through switchboard at (306)655-1000
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Pre-Administration Testing Requirements
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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
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Forms Required
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Supplies Required
| - Each carton of Nuwiq® includes the following:
- A single-use vial of Nuwiq® 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)
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| Administer the entire dose 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 Nuwiq®. No other drugs/solutions (including normal saline) can be co administered in the same line while Nuwiq® 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 Nuwiq®
1. Allow
the vials of Nuwiq® 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.
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| 2. Remove the plastic flip-top cap from the
concentrate vial to expose the central portions of the rubber stopper (Figure
A). Do not remove the gray stopper or metal ring around the top of the vial.
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| 3. Wipe the top of the vial with an alcohol swab.
Allow the alcohol to dry.
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| 4. Peel back the paper cover from the vial
adapter package. Do not remove the adapter from the package (Figure B).
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| 5. Place the concentrate vial on an even surface
and hold it. Take the adapter package and place the vial adapter over the
centre of the rubber stopper of the concentrate vial. Press down firmly the
adapter package until the adapter spike penetrates the rubber stopper. The
adapter snaps to the vial when done (Figure C).
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| 6. 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 (Figure D)
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| 7. Break off the tamper proof plastic tip from the solvent syringe by snapping the perforation of the cap. Do not touch the inside of the cap or the syringe tip (Figure E)
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| 8. Remove the adapter package and discard. Firmly connect the solvent syringe to the vial adapter by turning clockwise until resistance is felt (Figure F)
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| 9. Slowly inject all solvent into the
concentrate vial by pressing down the plunger rod (Figure G). Without removing
the syringe, dissolve the concentrate powder by gently moving or swirling the
vial in circles a few times. DO NOT SHAKE. Wait until all the powder dissolves
completely. Inspect the final solution for particles before administration. The
solution should be clear and colourless, practically free from visible
particles.
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| 10. 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.
| | 11. 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 (Figure H).
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- Lab testing post administration: As directed by most responsible healthcare practitioner (MRHP)
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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
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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 MRHP
- Document adverse events on Saskatchewan Transfusion Adverse Event Report Form #103695, whether or not the transfusion was discontinued
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Comments
| - Can contact the Saskatchewan Bleeding Disorders Program for education and administration assistance at (306)381-4185, Monday to Friday, 0800-1630
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