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Review our example profiles to learn how Rebinyn® may be right for your hemophilia B patients.

Clayton lives with hemophilia B and hikes

Review our example profiles to learn how Rebinyn® may be right for your hemophilia B patients.

Clayton lives with hemophilia B and hikes

All profiles are for illustrative purposes only.

Chris, 31

Moderate hemophilia B

  • Active, busy, travels for work
  • Multiple infusions often required with current SHL FIX
  • Bleeding episodes can take up to 3 days to control
  • Wants to minimize impact of treatment on his life

Would Rebinyn® be appropriate for Chris?

Flexible storage helps with traveling. Effective bleed control1,b and predicted fewer infusions required compared to SHL FIX2,3,c,f may fit his needs.

Explore Efficacy

Jonathan, 46

Severe hemophilia B

  • Experiences joint pain and swelling
  • Discomfort can last 1-3 days after a bleed
  • Pain sometimes limits his activities
  • Looking for shorter infusion times

How may Rebinyn® help Johnathan?

With effective bleed control,1,b higher factor activity than Alprolix®4,d and 4-minute infusions,1 Rebinyn® may require fewer doses and offer a good fit for Johnathan’s lifestyle.

See infusion details

Karl, 17

Mild hemophilia B

  • Dislikes how treatment interferes with his busy schedule—avoids infusing until he has to 
  • Current infusions take a long time and treatment doesn’t last long enough
  • Seeking an option that allows him to infuse as little as possible

Is Rebinyn® right for Karl?

High factor activity that lasts longer than Alprolix4,d and 4-minute infusions1 may fit his busy lifestyle.

Compare factor activity levels

Alex, 28

Moderate hemophilia

  • Active, but worries about long-term joint damage; starting to cut back on physical activity
  • Wants to feel like he’s protected when active 
  • Interested in trying new treatments 

Would Rebinyn® be appropriate for Alex?

High factor activity levels for longer.5,e Predicted fewer required doses3,c,f may be useful when deciding between EHL options.

See how Rebinyn® compares to Alprolix®

Juanita, mom of Oliver, 8

Severe hemophilia

  • Still learning how to handle bleeding episodes
  • Anxious about potential surgeries down the road
  • Putting off dental work due to concerns about bleeds

What does Rebinyn® offer Juanita and Oliver?

Simple dosing and 100% success in surgery,1 plus fast infusion and flexible storage to fit an on-the-go lifestyle.

Learn more about surgery use

Juanita, mom of Oliver, 8

Severe hemophilia

  • Still learning how to handle bleeding episodes
  • Anxious about potential surgeries down the road
  • Putting off dental work due to concerns about bleeds

What does Rebinyn® offer Juanita and Oliver?

Simple dosing1 plus fast infusion and flexible storage to fit an on-the-go lifestyle.

Learn more about surgery use

aProfiles are for illustrative purposes only; they are based on experiences of people who are living with hemophilia B but are not actual patients.

bResults shown are from the on-demand arm of the adolescent/adult trial, in which 15 previously treated adolescent/adult subjects were treated for on-demand bleeds. In 14 subjects, there were a total of 143 bleeding episodes. In 1 subject, no bleeding episode data were recorded.

cBased on PK modeling to World Federation of Hemophilia (WFH) guidelines. Simulated results based on two phase 1 PK studies of Rebinyn® (n=30), recombinant FIX (rFIX) (n=7), and plasma-derived FIX (pdFIX) (n=8), and rFIXFc (n=15).2,3

dBased upon a phase 1 study of 15 patients administered a single dose of Rebinyn® 50 IU/kg compared with a single dose of Alprolix 50 IU/kg using both 1-stage (shown above) and chromogenic assays. The standard Alprolix dose of 50 IU/kg was administered for both products to allow for comparison of dose-dependent parameters; dose normalized to 50 IU/kg to reflect minor differences in dose administered. Geometric mean half-life was also prolonged (Rebinyn®: 103.2 hours, Alprolix: 84.9 hours). All comparisons were significant (P<0.0001) for all assays.4

eBased upon a phase 1 study of patients administered 1 of 3 doses of Rebinyn® (25, 50 or 100 IU/kg) compared with one 50 IU/kg dose of their prior SHL recombinant FIX (rFIX) (n=7) or plasma-derived FIX (pdFIX) (n=8) using a 1-stage assay and product-specific standard. For Rebinyn®, estimated mean activity is adjusted to a dose of 50 IU/kg. Differences were similar in comparison of Rebinyn® to pdFIX (recovery 1.3 vs 1.1 IU/dL per IU/kg, 1.2x; half-life 93 vs 18 hours, 5.2x; area under the curve 70 vs 9 U x h/mL, 8x).5

fAn additional sensitivity analysis based on the Prescribing Information which notes Rebinyn 40 IU/kg may be administered in 1-3 day intervals within the first week of major surgery, additional Rebinyn 40 IU/kg doses were modeled on days 3, 6 and 13 (4 total doses).1


TRIAL PRESCRIPTION PROGRAM

Rebinyn® Product Box

Qualifying patients can receive a trial prescription for 1 month of Rebinyn®.

To learn more about our trial prescription program, please call 1-844-668-6732 to speak with a NovoSecure™ Specialist.

CONNECT WITH US

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Have a question about Rebinyn®? Novo Nordisk representatives are here to help.

TRIAL PRESCRIPTION PROGRAM

Qualifying patients can receive a trial prescription for 1 month of Rebinyn®.

To learn more about our trial prescription program, please call 1-844-668-6732 to speak with a NovoSecure™ Specialist.

CONNECT WITH US

Have a question about Rebinyn®? Novo Nordisk representatives are here to help.

GET THE LATEST UPDATES ON REBINYN®

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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.

References:

  1. Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc; June 2020. 
  2. Collins PW, Møss J, Knobe K, et al. Population pharmacokinetic modeling for dose setting of nonacog beta pegol (N9-GP), a glycoPEGylated recombinant factor IX. J Thromb Haemost. 2012;10(11):2305-2312.
  3. Simpson M, Kulkarni R, Ettingshausen C, et al. Population pharmacokinetic modeling of on-demand and surgical use of nonacog beta pegol (N9-GP) and rFIXFc based upon the paradigm 7 comparative pharmacokinetic study. J Blood Med. 2019;10:391–398.
  4. Ettingshausen C, Hegemann I, Simpson M, et al. Favorable pharmacokinetics in hemophilia B for nonacog beta pegol versus recombinant factor IX-Fc fusion protein: a randomized trial. Res Pract Thromb Haemost. 2019;3(2):268-276.
  5. Negrier C, Knobe K, Tiede A, Giangrande P, Møss J. Enhanced pharmacokinetic properties of a glycoPEGylated recombinant factor IX: a first human dose trial in patients with hemophilia B. Blood. 2011;118(10):2695-2701.