Description
| - Is a purified, sterile, freeze-dried concentrate of human blood coagulation factor IX. Immunine® VH is standardized in terms of factor IX content and each vial is labeled with the factor IX content indicated in international units
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Availability
| - Vial sizes/dosages:
- 500 units (480-720 units) per vial, reconstituted with 5 mL sterile water diluent
- 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
| - For the control and prevention of hemorrhagic episodes and for routine prophylaxis in patients with hemophilia B (congenital factor IX 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
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Contraindications
| - Hypersensitivity to any components of the product
- Known allergy to heparin or history of heparin induced thrombocytopenia
- Disseminated intravascular coagulation (DIC) and/or hyperfibrinolysis
- For a complete listing, see the contraindications section of the product monograph
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Warnings
| - Caution should be exercised in patients with a risk of thrombosis (ex. history of severe liver disease, thrombophilia, or a tentative or definitive diagnosis of angina pectoris, coronary heart disease, or myocardial infarction)
- 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 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. A physician experienced in the care of bleeding disorder patients should be consulted in the case of a suspected factor IX (9) 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-Transfusion Testing Requirements
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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
- To request product from the transfusion medicine laboratory, use the Plasma Protein Product Request Form #103221
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Forms Required
| - Informed Consent for Blood Components and/or Plasma Protein Products #101479
- 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)
- Notification of Administration of Blood and/or Blood Products Form #103854
- Forms can be located in the Lab Service Manual or Forms on Demand
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Supplies Required
| - Each carton of Immunine® VH includes the following:
- A single-use Immunine® VH vial
- A Vial of 5 mL sterile water as diluent for reconstitution
- A Baxject II Hi-Flow reconstitution device
- Additional supplies needed:
- One butterfly infusion set (can use if patient does not have an IV in place)
- One luer lock syringe (appropriate size based on volume)
- Sterile alcohol swabs (for cleaning the tops of the vials)
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Administration
| - Blood consent: Is required due to human plasma component
- Pre-Infusion: Ensure recent patient weight is on file and pertinent laboratory results are available
- Perform all other appropriate pre-transfusion checks per protocol. See Nursing Policy and Procedure Blood Components and Plasma Protein Product - Administration of #1141
- Administration:
Administer the entire dose by slow intravenous injection at a rate not exceeding 2 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 Immunine® VH. No other drugs/solutions (including normal saline) can be co-administered in the same line while Immunine® VH 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 Immunine® VH
Allow the vials of Immunine® VH and diluent to reach room temperature before use. This can be done by warming of both unopened vials in your hands to a comfortable temperature (do not exceed 37°C) 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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| Remove protective caps from the rubber-capped vials containing the powder and the solvent (fig. A) and cleanse the rubber stoppers of both
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| Remove protective covering from one end of the enclosed transfer needle by twisting and pulling. Insert the needle through the rubber stopper of the solvent vial (Fig. B and C)
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| Remove protective covering from the other end of the transfer needle taking care not to touch the exposed end
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| Invert the solvent vial over the powder vial and insert the free end of the transfer needle through the rubber stopper of the powder vial (fig. D). The solvent will be drawn in by the vacuum in the powder vial
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| After the entire solvent has flowed into the powder vial, disconnect the two vials by removing the transfer needle from the powder vial (fig. E). Gently agitate the powder vial to accelerate dissolution
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| Upon complete reconstitution of the powder, insert the enclosed aeration needle (fig. F) and any foam will collapse. Remove the aeration needle.
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| Remove protective covering from the enclosed filter needle by twisting and pulling and fit the needle onto the sterile disposable syringe. Draw the solution into the syringe (fig. G)
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- Lab testing post administration: As directed by most responsible healthcare practitioner (MRHP)
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Nursing Implications
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Adverse Events
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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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