Fast infusions to fit in your patients’ lives. Preparing a dose is as quick as attach, twist, mix.

Can be infused in

Fast infusions to fit in your patients’ lives. Preparing a dose is as quick as attach, twist, mix.

Can be infused in

WHAT'S INCLUDED IN THE REBINYN® PACKAGE:

Vial with color-coded cap

Differentiate dose strengths through color-coded vial caps.1

3 different Rebinyn® vials with peel-off labels

Adapter

Connects the syringe and vial, with a 25-μm inline particle filter.1

Syringe-to-vial adapter

Prefilled diluent syringe

Contains 4 mL of diluent—works with any dose strength.1

Prefilled syringe with diluent for reconstruction of Rebinyn®

BASIC RECONSTITUTION STEPS

Attach1,a

Twist1,a

Mix1,a

After mixing, the reconstituted solution can be administered within 4 hours.

aFor complete instructions on reconstitution and administration, please refer to the Instructions for Use

PREPARATION

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

ADMINISTRATION: FOR INTRAVENOUS INFUSION ONLY

Invert the Rebinyn® vial to draw the solution into the syringe

Administer using the following procedure:

  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.

  • 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. 
  • Inspect the reconstituted Rebinyn® solution visually prior to administration. 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. 

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.

Please note, this is not the complete Rebinyn® instructions for use. Please refer to the Instructions for Use included in the Prescribing Information.

EFFECTIVE BLEED CONTROL

Jason, who lives with hemophilia B, plays with his dad in a garden

Clinical trials show the efficacy of Rebinyn® in controlling bleeds.1   

SIMPLIFIED DOSING

Rebinyn® dosing icon

Fixed dosing for all patients means no calculating desired FIX activity levels.1

EFFECTIVE BLEED CONTROL


Clinical trials show the efficacy of Rebinyn® in controlling bleeds.1   
 

SIMPLIFIED DOSING


Fixed dosing for all patients means no calculating desired FIX activity levels.1  
 

REGISTER TO GET THE LATEST UPDATES ON REBINYN®

Website link

REGISTER TO GET THE LATEST UPDATES ON REBINYN®

Selected Important Safety Information

Contraindications

  • Rebinyn® is contraindicated in patients with a known hypersensitivity to Rebinyn® or its components, including hamster proteins.

Warnings and Precautions

Hypersensitivity reactions, including anaphylaxis, may occur. Signs may include angioedema, chest tightness, difficulty breathing, wheezing, urticaria, and itching. Discontinue Rebinyn® if allergic or anaphylactic type reactions occur and initiate appropriate treatment.

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 and perioperative management of bleeding.

Limitations of Use: Rebinyn® is not indicated for routine prophylaxis or for immune tolerance induction in patients with hemophilia B.

Important Safety Information

Contraindications

  • Rebinyn® is contraindicated in patients with a known hypersensitivity to Rebinyn® or its components, including hamster proteins.

Warnings and Precautions

  • Hypersensitivity reactions, including anaphylaxis, may occur. Signs may include angioedema, chest tightness, difficulty breathing, wheezing, urticaria, and itching. Discontinue Rebinyn® if allergic or anaphylactic-type reactions occur and initiate appropriate treatment.
  • Development of neutralizing antibodies (inhibitors) to Factor IX  may occur. Monitor patients for development of Factor IX inhibitors if bleeding is not controlled with the recommended dose of Rebinyn® or if expected Factor IX activity plasma levels are not attained. Factor IX activity assay results may vary with the type of activated partial thromboplastin time reagent used.
  • The use of Factor IX-containing products has been associated with thrombotic complications. Monitor for thrombotic and consumptive coagulopathy when administering Rebinyn® to patients with liver disease, post-operatively, to newborn infants, or to patients at risk of thrombosis or disseminated intravascular coagulation (DIC).
  • Nephrotic syndrome has been reported following immune tolerance induction therapy with Factor IX products in hemophilia B patients with Factor IX inhibitors, often with a history of allergic reactions to Factor IX. The safety and efficacy of using Rebinyn® for immune tolerance induction have not been established.

Adverse Reactions

  • The most common adverse reactions reported in clinical trials (≥1%) were itching and injection site reactions.
  • Animals administered repeat doses of Rebinyn® showed accumulation of PEG in the choroid plexus. The potential clinical implications of these animal findings are unknown.

Please click here for Prescribing Information.

Reference:

  1. Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc; May 2017.