Drug Detail:Rebinyn (Coagulation factor ix [ koe-ag-yoo-lay-shun-fak-tor-nine ])
Generic Name: COAGULATION FACTOR IX RECOMBINANT HUMAN 125[iU] in 1mL;
Dosage Form: kit
Drug Class: Miscellaneous coagulation modifiers
For intravenous infusion after reconstitution only.
Dosing Guidelines
- •
- Dose and duration of treatment depend on the location and extent of bleeding, and the patient’s clinical condition.
- •
- If monitoring of Factor IX activity is performed, use a chromogenic assay or selected one-stage clotting assay validated for use with REBINYN [see Warnings and Precautions (5.5)].
- •
- Each carton and vial label for REBINYN states the actual Factor IX potency in IU.
On-demand Treatment and Control of Bleeding Episodes
REBINYN dosing for on-demand treatment and control of bleeding episodes is provided in Table 1.
Table 1: Dosing for On-demand Treatment and Control of Bleeding Episodes
|
Type of bleeding |
Recommended dose IU/kg body weight |
Additional information |
|
Minor and moderate For example: Uncomplicated joint bleeds, minor muscular bleeds, mucosal or subcutaneous bleeds |
40 |
A single dose should be sufficient for minor and moderate bleeds. Additional doses of 40 IU/kg can be given. |
|
Major For example: Intracranial, retroperitoneal, iliopsoas and neck bleeds, muscle bleeds with compartment syndrome and bleeds associated with a significant decrease in the hemoglobin level |
80 |
Additional doses of 40 IU/kg can be given. |
Perioperative Management
REBINYN dosing for perioperative management is provided in Table 2.
Table 2: Dosing for Perioperative Management
|
Type of surgical procedure |
Recommended dose IU/kg body weight |
Additional Information |
|
Minor For example: Implanting pumps in subcutaneous tissue, skin biopsies or simple dental procedures |
40 |
A single pre-operative dose should be sufficient. Additional doses can be given if needed. |
|
Major For example: Body cavity is entered, mesenchymal barrier is crossed, fascial plane is opened, organ is removed, normal anatomy is operatively altered |
80 |
Pre-operative dose |
|
40 |
As clinically needed for the perioperative management of bleeding, repeated doses of 40 IU/kg (in 1-3 day intervals) within the first week after major surgery may be administered.* Due to the long half-life of REBINYN, the frequency of dosing in the post-surgical setting may be extended to once weekly after the first week until bleeding stops and healing is achieved. |
*See 12.3 Pharmacokinetics, Table 8
Routine Prophylaxis
For prophylaxis use, the recommended dose is 40 IU/kg body weight once weekly.
Adjust dosing regimen based on individual patient’s bleeding pattern, and physical activity.
Reconstitution
- •
- Always wash hands and ensure that the area is clean before performing the reconstitution procedures.
- •
- Use aseptic technique during the reconstitution procedures.
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- If the patient uses more than one vial of REBINYN per infusion, reconstitute each vial according to the following instructions.
Overview of REBINYN Package
The instructions below serve as a general guideline for reconstitution of REBINYN. For full instructions, refer to the FDA-approved patient information and Instructions for Use.
Reconstitution
- 1.
- Bring the REBINYN vial and the pre-filled diluent syringe to room temperature.
- 2.
- Remove the plastic cap from the REBINYN vial.
- 3.
- Wipe the rubber stopper on the vial with a sterile alcohol swab and allow it to dry prior to use.
- 4.
- Remove the protective paper from the vial adapter. Do not remove the vial adapter from the protective cap.
- 5.
- Place the vial on a flat and solid surface. While holding the protective cap, place the vial adapter over the REBINYN vial and press down firmly on the protective cap until the vial adapter spike penetrates the rubber stopper.
- 6.
- Remove the protective cap from the vial adapter.
- 7.
- Grasp the plunger rod as shown in the diagram. Attach the plunger rod to the syringe by holding the plunger rod by the wide top end. Turn the plunger rod clockwise into the rubber plunger inside the pre-filled diluent syringe until resistance is felt.
- 8.
- Break off the syringe cap from the pre-filled diluent syringe by snapping the perforation of the cap.
- 9.
- Connect the pre-filled diluent syringe to the vial adapter by turning it clockwise until it is secured.
- 10.
- Push the plunger rod to slowly inject all the diluent into the vial.
- 11.
- Without removing the syringe, gently swirl the REBINYN vial until all of the powder is dissolved.
- 12.
- Administer the REBINYN solution immediately [see Administration (2.3)]. If not used immediately after reconstitution, store the solution in the vial with the vial adapter and the syringe attached, at room temperature ≤ 86°F (30°C). Do not store for longer than 4 hours.
Administration
For intravenous infusion only.
- •
- Accidental needle stick with a needle contaminated with blood can transmit infectious viruses including HIV (AIDS) and hepatitis. If a needle stick occurs, obtain immediate medical attention. Place needles in a sharps container after single use.
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- Inspect the reconstituted REBINYN solution visually prior to administration [see Description (11)]. The solution should be clear and have no particles. Do not use if particulate matter or discoloration is observed.
- •
- Do not administer REBINYN in the same tubing or container with other medicinal products.
- 1.
- Invert the REBINYN vial and slowly draw the solution into the syringe.
- 2.
- Detach the syringe from the vial adapter by turning the syringe counterclockwise.
- 3.
- Attach the syringe to the luer end of an infusion needle set.
- 4.
- Infuse the reconstituted REBINYN intravenously slowly over 1 to 4 minutes.
- 5.
- After infusion, safely dispose of the syringe with the infusion set, the vial with the vial adapter, any unused REBINYN, and other waste materials.
Caution: The pre-filled diluent syringe is made of glass with an internal tip diameter of 0.037 inches, and is compatible with a standard Luer-lock connector.
Some needleless connectors for intravenous catheters are incompatible with the glass diluent syringes (for example, certain connectors with an internal spike, such as Clave® /MicroClave®, InVision-Plus®, InVision-Plus CS®, Invision-Plus Junior®, Bionector®), and their use can damage the connector and affect administration. To administer REBINYN through incompatible needleless connectors, withdraw the reconstituted product into a standard 10 mL sterile Luer-lock plastic syringe.
If you encounter any problems with attaching the pre-filled histidine-diluent syringe to any Luer‐lock compatible device, please contact Novo Nordisk at (844) 303-4448.
