Description
| - REBINYN® is a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution with the provided histidine diluent for intravenous injection
- REBINYN®is produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells. No additivies of human or animal origin are used in the cell culture, purification, conjugation or formulation of REBINYN. The conjugation of the PEG-group is done by enzymatic reaction during the purification of REBINYN®
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Availability
| - Vial sizes/dosages:
- 500 units, 1000 units and 2000 units per vial and is supplied with 4 mL prefilled syringe of sodium chloride 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
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Contraindications
| - Patients who do not have hemophilia B (factor IX (9) deficiency)
- Known hypersensitivity to this drug or to any ingredients in the formulation (including hamster protein), or component of the container
- For a complete listing, see the contraindications section of product monograph
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Warnings
| - The use of factor IX (9) containing products has been associated with thrombotic complications. Due to the potential risk of thrombotic complications, it is recommended to monitor patients for early signs of thrombotic and consumptive coagulopathy when administering this product to patients with liver disease, post-operatively, new-born infants or patients at risk of thrombotic phenomena or DIC
- 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 activity levels are not attained, or if bleeding is not contyrolled with an appropriate dose, an assay that measures factor IX 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 by paging 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 the 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 Product Request Form #103221
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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 Service Manual or Forms on Demand
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Supplies Required
| - Each carton of REBINYN® includes the following:
- A single-use vial of REBINYN® powder
- A prefilled diluent syringe containing sodium chloride diluent
- A vial adaptor (with 25 micrometer filter) transfer device
- One plunger rod
- 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) for administration
- Sterile alcohol swabs (for cleaning the tops of the vials)
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Administration
| - Blood consent: Is NOT required as REBINYN 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:
Administration of the entire dose should be determined by the patient's comfort level, up to a maximum injection 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 and pre and post administration of REBINYN®. No other drugs/solutions (including normal saline) can be co-administered in the same line while REBINYN® is being infused
- Preparation and Reconstitution:
Note: Reconstitute only immediately before administration
- Administer as soon as possible, if you cannot use the reconstituted REBINYN® solution immediately, it should be kept in the vial (with the vial adapter and the syringe still attached) and stored at room temperature (below 25°C) for no longer than 4 hours or refrigerated (2°C to 8°C) for no longer than 24 hours. Store the reconstituted product in the vial. 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 REBINYN
Allow the vials of REBINYN® 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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| Remove the plastic cap from the vial. If the plastic cap is loose or missing, do not use the vial
| | Wipe the rubber stopper with a sterile alcohol swab and allow it to air dry for a few seconds before use to ensure that it is as germ free as possible
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| Remove the protective paper from the vial adapter. If the protective paper is not fully sealed or if it is broken, do not use the vial adapter
Do not take the vial adapter out of the protective cap with your fingers. If you touch the spike on the vial adapter germs from your fingers can be transferred
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| Place the concentrate vial on a flat and solid surface. Turn over the protective cap and place the vial adaptor over the center of the rubber stopper of the concentration vial. Press down firmly on the adaptor package until the adaptor spike penetrates the rubber stopper. The adaptor snaps onto the vial when done
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| Grasp the plunger rod by the wide top end and take it out of the carton and avoid contact with the shaft. Attach the threaded end of the plunger rod to the diluent syringe plunger. Turn clockwise until a slight resistance is felt.
NOTE: Do not reconstitute with anything other than the provided diluent
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| Remove the tamper-proof plastic tip from the prefilled syringe by bending it down until the perforation breaks. Do not touch the syringe tip under the syringe cap
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| Remove the adapter packaging and discard. Firmly connect the diluent syringe to the vial adaptor by turning clockwise until resistance is felt
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| Slowly inject all solvent into the concentrate vial by pressing down on the plunger
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| Without removing the syringe, dissolve the concentrate powder by gently moving or swirling the vial in circles a few times. DO NOT SHAKE
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| Inspect the solution for particles. Do not use solutions that are cloudy or have deposits. Since the glass diluent syringes are not compatible with the 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 and draw back the reconstituted contents. Make sure the entire content of the vial is transferred into the syringe
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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 event 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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