REBINYN

REBINYN- (coagulation factor ix (recombinant), glycopegylated)
Novo Nordisk

1 INDICATIONS AND USAGE

REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B for:

On-demand treatment and control of bleeding episodes
Perioperative management of bleeding

Limitations of Use: REBINYN is not indicated for routine prophylaxis in the treatment of patients with hemophilia B. REBINYN is not indicated for immune tolerance induction in patients with hemophilia B.

2 DOSAGE AND ADMINISTRATION

For intravenous infusion after reconstitution only.

2.1 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

2.2 Reconstitution

Always wash hands and ensure that the area is clean before performing the reconstitution procedures.
Use aseptic technique during the reconstitution procedures.
If the patient uses more than one vial of REBINYN per infusion, reconstitute each vial according to the following instructions.

Overview of REBINYN Package

Overview of REBINYN Package
(click image for full-size original)

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.
Fig. A
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2.
Remove the plastic cap from the REBINYN vial.
Fig. B
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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.
Fig. C
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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.
Fig. D
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6.
Remove the protective cap from the vial adapter.
Fig. E
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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.
Fig. F
(click image for full-size original)
8.
Break off the syringe cap from the pre-filled diluent syringe by snapping the perforation of the cap.
FIg. G
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9.
Connect the pre-filled diluent syringe to the vial adapter by turning it clockwise until it is secured.
Fig. H
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10.
Push the plunger rod to slowly inject all the diluent into the vial.
Fig. I
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11.
Without removing the syringe, gently swirl the REBINYN vial until all of the powder is dissolved.
Fig. J
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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.

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