Medical Information
|
Non-US Health Care Professionals
Account Settings
Sign Out
Sign In | Create Account
  • Rare Bleeding Disorders Home
  •  Icon
    Products
    Our Treatments
    How to Order
    Trial Prescriptions
    Recombinant Manufacturing
     Icon
    Professional Resources
    Product Resources Library
    Contact Your Representative
    Medical Information
    |
    Non-US Health Care Professionals
  •  Icon
    Disease Education
    Clinical Education Library
    Congenital Hemophilia with Inhibitors
    Breakthrough Bleeds
    Acquired Hemophilia
    Glanzmann's Thrombasthenia
    Interactive Joint Bleed Model
     Icon
    Treatment Guidelines
    MASAC Guidelines
    WFH Guidelines
     Icon
    Additional Resources
    Organizations & Conferences
    Medical Information
    |
    Non-US Health Care Professionals
  •  Icon
    Product Education
    Product Education Materials
     Icon
    Disease Education
    Disease Education Resources
     Icon
    Access & Affordability
    Prescription Savings & Insurance Support
    ICD-10 Codes for Rare Bleeding Disorders
    Medical Information
    |
    Non-US Health Care Professionals
Rare Bleeding Disorders
Rebinyn® coagulation factor IX (recombinant), glycoPEGylated logo
  • How it Works Patient Use Cases
  • Prophylaxis On Demand Perioperative Safety Profile
  • Pharmacokinetics FIX PK Comparisons Comparative Modeling
  • Simplified Dosing Reconstitution & Administration
  • Cost & Coverage
  • Patient Education Education for You How to Order
Prescribing Information | Important Safety Information | Patient Site

Explore Therapeutic Areas

Diabetes Icon
Diabetes
Our broad treatment portfolio supports individualized patient care.
Obesity Icon
Obesity
Our treatments are part of a comprehensive approach to weight-loss management.
Growth-Related Disorders Icon
Growth-Related Disorders
Our products help children with a range of growth-related disorders and adults with growth hormone deficiency.
Rare Bleeding Disorders Icon
Rare Bleeding Disorders
Our commitment to patients with hemophilia and rare bleeding disorders is reflected in our broad therapy portfolio.
Rare Renal Disorders Icon
Rare Renal Disorders
Our treatment helps patients with the rare genetic disorder primary hyperoxaluria type 1 (PH1).
Medical Information
|
Non-US Health Care Professionals
  • Rare Bleeding Disorders Home
Account Settings
Sign Out
Sign In | Create Account
Update your account
Medical Information
|
Non-US Health Care Professionals

Explore the Hub

Products
Samples
Patient Savings
Contact

Explore Therapeutic Areas

Diabetes
Diabetes
Obesity
Obesity
Growth-Related Disorders
Growth-Related Disorders
Rare Bleeding Disorders
Rare Bleeding Disorders
Rare Renal Disorders
Rare Renal Disorders
Claim your personalized professional hub
What can novoMEDLINK™ do for you? With your account you can discover professional news, order samples, get supply updates, browse patient support materials, and much more.
Personalize your novoMEDLINK™ experience
Ready to further optimize your content recommendations and resource suggestions? Head to your account page to edit your settings.
Account Settings
Sign Out
Sign In | Create Account
Update your account
  • Products
    Samples
    Patient Savings
    Contact
    Diabetes
    Diabetes
    Obesity
    Obesity
    Growth-Related Disorders
    Growth-Related Disorders
    Rare Bleeding Disorders
    Rare Bleeding Disorders
    Rare Renal Disorders
    Rare Renal Disorders
Claim your personalized
professional hub
Personalize your novoMEDLINK™ experience
Account Settings
Sign Out
Sign In | Create Account
Update your account
Medical Information
|
Non-US Health Care Professionals
  • Rare Bleeding Disorders Home
  •  Icon
    Products
    Our Treatments
    How to Order
    Trial Prescriptions
    Recombinant Manufacturing
     Icon
    Professional Resources
    Product Resources Library
    Contact Your Representative
  •  Icon
    Disease Education
    Clinical Education Library
    Congenital Hemophilia with Inhibitors
    Breakthrough Bleeds
    Acquired Hemophilia
    Glanzmann's Thrombasthenia
    Interactive Joint Bleed Model
     Icon
    Treatment Guidelines
    MASAC Guidelines
    WFH Guidelines
     Icon
    Additional Resources
    Organizations & Conferences
  •  Icon
    Product Education
    Product Education Materials
     Icon
    Disease Education
    Disease Education Resources
     Icon
    Access & Affordability
    Prescription Savings & Insurance Support
    ICD-10 Codes for Rare Bleeding Disorders
Medical Information
|
Non-US Health Care Professionals

Explore Current Therapy Area

Rare Bleeding Disorders Home
Products
Our Treatments
How to Order
Trial Prescriptions
Recombinant Manufacturing
Professional Resources
Product Resources Library
Contact Your Representative
Disease Education
Clinical Education Library
Congenital Hemophilia with Inhibitors
Breakthrough Bleeds
Acquired Hemophilia
Glanzmann's Thrombasthenia
Interactive Joint Bleed Model
Treatment Guidelines
MASAC Guidelines
WFH Guidelines
Additional Resources
Organizations & Conferences
Product Education
Product Education Materials
Disease Education
Disease Education Resources
Access & Affordability
Prescription Savings & Insurance Support
ICD-10 Codes for Rare Bleeding Disorders
Diabetes
Diabetes
Obesity
Obesity
Growth-Related Disorders
Growth-Related Disorders
Rare Bleeding Disorders
Rare Bleeding Disorders
Rare Renal Disorders
Rare Renal Disorders
Medical Information
|
Non-US Health Care Professionals
Claim your personalized professional hub
What can novoMEDLINK™ do for you? With your account you can discover professional news, order samples, get supply updates, browse patient support materials, and much more.
Personalize your novoMEDLINK™ experience
Ready to further optimize your content recommendations and resource suggestions? Head to your account page to edit your settings.
Account Settings
Sign Out
Sign In | Create Account
Update your account

Explore Current Therapy Area

  • Rare Bleeding Disorders Home
  •  Icon
    Products
    Our Treatments
    How to Order
    Trial Prescriptions
    Recombinant Manufacturing
     Icon
    Professional Resources
    Product Resources Library
    Contact Your Representative
  •  Icon
    Disease Education
    Clinical Education Library
    Congenital Hemophilia with Inhibitors
    Breakthrough Bleeds
    Acquired Hemophilia
    Glanzmann's Thrombasthenia
    Interactive Joint Bleed Model
     Icon
    Treatment Guidelines
    MASAC Guidelines
    WFH Guidelines
     Icon
    Additional Resources
    Organizations & Conferences
  •  Icon
    Product Education
    Product Education Materials
     Icon
    Disease Education
    Disease Education Resources
     Icon
    Access & Affordability
    Prescription Savings & Insurance Support
    ICD-10 Codes for Rare Bleeding Disorders
  • Diabetes
    Diabetes
    Obesity
    Obesity
    Growth-Related Disorders
    Growth-Related Disorders
    Rare Bleeding Disorders
    Rare Bleeding Disorders
    Rare Renal Disorders
    Rare Renal Disorders

Claim your personalized
professional hub

Personalize your novoMEDLINK™ experience

Account Settings
Sign Out
Sign In | Create Account
Update your account
Medical Information
|
Non-US Health Care Professionals
  • How it Works
    Patient Use Cases
  • Prophylaxis
    On Demand
    Perioperative
    Safety Profile
  • Pharmacokinetics
    FIX PK Comparisons
    Comparative Modeling
  • Simplified Dosing
    Reconstitution & Administration
  • Cost & Coverage
  • Patient Education
    Education for You
    How to Order
Prescribing Information | Important Safety Information | Patient Site
Medical Information
|
Non-US Health Care Professionals
 |  Important Safety Information

NovoSeven® RT (coagulation Factor VIIa, recombinant)

Alhemo® (concizumab-mtci) injection 60 mg, 150 mg, 300 mg pens

Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei]

Novoeight® (antihemophilic factor, recombinant)

Rebinyn® coagulation factor IX (recombinant), glycoPEGylated

Tretten® (coagulation factor XIII A-subunit [recombinant])

    • How it Works
    • Patient Use Cases
    • Prophylaxis
    • On Demand
    • Perioperative
    • Safety Profile
    • Pharmacokinetics
    • FIX PK Comparisons
    • Comparative Modeling
    • Simplified Dosing
    • Reconstitution & Administration
  • Cost & Coverage
    • Patient Education
    • Education for You
    • How to Order

For use in adults and children with hemophilia B for on demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. Not for immune tolerance induction.

Comparing FIX PK activity: Rebinyn® vs SHL and EHL

Rebinyn® provides higher incremental recovery, a longer half-life, and greater area under the curve (AUC) than BeneFIX® or Alprolix®.1-3,a,b

Jason has hemophilia B and uses Rebinyn®.

Comparing FIX PK activity: Rebinyn® vs SHL and EHL

Rebinyn® provides higher incremental recovery, a longer half-life, and greater area under the curve (AUC) than BeneFIX® or Alprolix®.1-3,a,b

Jason has hemophilia B and uses Rebinyn®.

PK=pharmacokinetic.

aPhase 1 trial comparing PK of Rebinyn® with SHL FIX products (Negrier, et al). Based upon a phase 1 study of patients administered 1 of 3 doses of Rebinyn® (25, 50, or 100 IU/kg) compared with 1 dose of their prior SHL rFIX (n=7) or pdFIX (n=8) at the same dose using a 1-stage assay. Estimated mean PK parameters were adjusted to a dose of 50 IU/kg. Differences were similar in comparison of Rebinyn® to pdFIX (half-life 93 vs 18 hours, 5.2x; P<0.001; AUC 70 vs 9 U x h/ml, 8x, P<0.001) and in comparison of Rebinyn® to rFIX (half-life 93 vs 19 hours, P<0.001; AUC 72 vs 7 U x h/ml, P<0.001). The clinical relevance of these PK differences is unknown.1

bPhase 1 trial comparing PK of Rebinyn® with Alprolix® (Ettingshausen, et al). Based upon a phase 1 study of 15 patients administered a single dose of Rebinyn® 50 IU/kg compared with a single dose of Alprolix® 5O IU/kg using both 1-stage 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 5O 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. The clinical relevance of these PK differences is unknown.3

Compare Rebinyn® with BeneFIX®

In a phase 1 study, Rebinyn® allowed patients to achieve and maintain a higher factor level compared with BeneFIX®.1,a The clinical relevance of these PK differences is unknown.

See study design

Rebinyn® achieved and maintained higher factor activity for longer1,a

Factor IX over time chart

The half-life of Rebinyn® was 93 hours vs 19 hours for BeneFIX®.1,a

Compare Rebinyn® with Alprolix®

In the paradigm 7 study, Rebinyn® allowed patients to achieve and maintain a higher factor level compared with Alprolix®.3,b The clinical relevance of these PK differences is unknown.

See study design

Rebinyn® achieved and maintained higher factor activity for longer3,b

Chart showing factor IX activity over time

The half-life of Rebinyn® was 103 hours vs 85 hours for Alprolix®.3,b

Rebinyn® can help raise Factor IX levels so your patients can be ready for the unexpected.4

See PPx efficacy data

Would switching to Rebinyn® prophylaxis help a patient like Colin?

Colin is 46 and lives with severe hemophilia B. He experiences joint pain that sometimes limits his activities, and he is looking for a treatment that keeps him in the non-hemophilia range for as long as possible.

Find out more about what patients like Colin look for when considering a therapy switch.

See patient profiles
Colin patient profile

For illustrative purposes.


Study designs

Medicine vial icon

Negrier et al (2011)1
paradigm 1: Rebinyn® first human dose trial, including pharmacokinetic analysis

Patients: 15 previously treated male hemophilia B patients with FIX activity ≤2% and at least 150 days of exposure to a FIX product before enrollment.

Study design: Open-label dose escalation trial. Patients were administered one of three doses of Rebinyn® (25, 50, or 100 IU/kg) no less than 7 days after receiving the same dose of their prior SHL rFIX (N=7) or pdFIX (N=8). Blood samples for pharmacokinetic analysis were drawn before dose and again at 30 mins for dosing with any product, as well as at 7 intervals after dosing with a patient’s prior product (ending at 48 hours postdose) and 13 intervals after dosing with Rebinyn® (ending at 4 weeks after dosing). Inhibitors were measured using a Nijmegan modified Bethesda assay, and FIX activity was measured using a modified aPTT assay.

Primary endpoint: Safety of Rebinyn® as evaluated by adverse events, antibody formation including inhibitors against FIX and Rebinyn®, physical examination, vital signs, electrocardiogram, injection site reactions, urinalysis, and clinical laboratory asessments.

Secondary endpoint: Pharmacokinetic assessment of Rebinyn® and comparison to other FIX products, based on FIX coagulation activity measurements.

Ettinghausen et al (2019)3
paradigm 7: open-label crossover trial comparing Rebinyn® and recombinant Factor IX-Fc fusion protein (rFIXFc)

Patients: 15 previously treated male patients aged 18 to 70 years with hemophilia B. Patients had FIX activity ≤2 IU/dL and at least 150 exposure days to any FIX product.

Study design: Patients were randomly assigned a single 50 IU/kg dose of either Rebinyn® or rFIXFc, followed by a 50 IU/kg dose of the other product at least 21 days later. Pharmacokinetic (PK) assessment was performed on blood samples drawn over 10 days postdose for each product, using both 1-stage and chromogenic assays.

Primary endpoint: Area under the FIX activity-time curve for each product.

Secondary endpoints: PK endpoints including maximum FIX activity dose-normalized to 50 IU/kg, terminal half-life, and incremental recovery at 30 minutes.

Compare PK of FIX products using modeling data

Modeling data icon

Explore PK modeling data comparing Rebinyn® with SHL and EHL FIX products.

See PK modeling data

Established safety profile

Checklist and vial icon

Clinical trials showed 0 inhibitors and thrombotic events in previously treated patients in 5 clinical trials over 13 years.2,5

View the data

The formation of inhibitors (neutralizing antibodies) to Factor IX (FIX) has occurred following Rebinyn®. Common adverse reactions (≥1%) in previously untreated patients reported in clinical trials included FIX inhibitors.

Show More Show Less

Important Safety Information for Rebinyn®

Contraindications

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

Warnings and Precautions

  • Hypersensitivity Reactions: Allergic-type hypersensitivity reactions, including anaphylaxis, have occurred with Rebinyn®. 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.
  • Inhibitors: The formation of inhibitors (neutralizing antibodies) to Factor IX has occurred following Rebinyn®. If expected plasma factor IX activity levels are not attained, or if bleeding is not controlled as expected with the administered dose, perform an assay that measures Factor IX inhibitor concentration. Monitor all patients using clinical observations and laboratory tests for the development of inhibitors. Factor IX activity assay results may vary with the type of activated partial thromboplastin time reagent used.
  • Thrombotic Events: The use of Factor IX-containing products has been associated with thromboembolic 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: 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 previously treated patients in clinical trials (≥1%) were itching and injection site reactions. The most common adverse reactions (≥1%) in previously untreated patients reported in clinical trials were rash, FIX inhibitors, hypersensitivity, itching, injection site reaction, and anaphylactic reaction.
  • Animals administered Rebinyn® showed accumulation of PEG in the choroid plexus, pituitary, circumventricular organs, and cranial motor neurons. The potential clinical implications of these animal findings are unknown. Consider whether the patient is vulnerable to cognitive impairment, such as infants and children who have developing brains, and patients who are cognitively impaired.

Please click here for Rebinyn® Prescribing Information.

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 (congenital Factor IX deficiency) for on demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. 

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

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 (congenital Factor IX deficiency) for on demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. 

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

Important Safety Information for Rebinyn®

Contraindications

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

Warnings and Precautions

  • Hypersensitivity Reactions: Allergic-type hypersensitivity reactions, including anaphylaxis, have occurred with Rebinyn®. 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.
  • Inhibitors: The formation of inhibitors (neutralizing antibodies) to Factor IX has occurred following Rebinyn®. If expected plasma factor IX activity levels are not attained, or if bleeding is not controlled as expected with the administered dose, perform an assay that measures Factor IX inhibitor concentration. Monitor all patients using clinical observations and laboratory tests for the development of inhibitors. Factor IX activity assay results may vary with the type of activated partial thromboplastin time reagent used.
  • Thrombotic Events: The use of Factor IX-containing products has been associated with thromboembolic 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: 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 previously treated patients in clinical trials (≥1%) were itching and injection site reactions. The most common adverse reactions (≥1%) in previously untreated patients reported in clinical trials were rash, FIX inhibitors, hypersensitivity, itching, injection site reaction, and anaphylactic reaction.
  • Animals administered Rebinyn® showed accumulation of PEG in the choroid plexus, pituitary, circumventricular organs, and cranial motor neurons. The potential clinical implications of these animal findings are unknown. Consider whether the patient is vulnerable to cognitive impairment, such as infants and children who have developing brains, and patients who are cognitively impaired.

Please click here for Rebinyn® Prescribing Information.

Show More Show Less
Show More Show Less

Indications and Usage

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 (congenital Factor IX deficiency) for on demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. 

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

Important Safety Information for Rebinyn®

Contraindications

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

Important Safety Information for Rebinyn®

Contraindications

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

Warnings and Precautions

  • Hypersensitivity Reactions: Allergic-type hypersensitivity reactions, including anaphylaxis, have occurred with Rebinyn®. 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.
  • Inhibitors: The formation of inhibitors (neutralizing antibodies) to Factor IX has occurred following Rebinyn®. If expected plasma factor IX activity levels are not attained, or if bleeding is not controlled as expected with the administered dose, perform an assay that measures Factor IX inhibitor concentration. Monitor all patients using clinical observations and laboratory tests for the development of inhibitors. Factor IX activity assay results may vary with the type of activated partial thromboplastin time reagent used.
  • Thrombotic Events: The use of Factor IX-containing products has been associated with thromboembolic 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: 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 previously treated patients in clinical trials (≥1%) were itching and injection site reactions. The most common adverse reactions (≥1%) in previously untreated patients reported in clinical trials were rash, FIX inhibitors, hypersensitivity, itching, injection site reaction, and anaphylactic reaction.
  • Animals administered Rebinyn® showed accumulation of PEG in the choroid plexus, pituitary, circumventricular organs, and cranial motor neurons. The potential clinical implications of these animal findings are unknown. Consider whether the patient is vulnerable to cognitive impairment, such as infants and children who have developing brains, and patients who are cognitively impaired.

Please click here for Rebinyn® Prescribing Information.

Important Safety Information for Rebinyn®

Contraindications

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

Warnings and Precautions

  • Hypersensitivity Reactions: Allergic-type hypersensitivity reactions, including anaphylaxis, have occurred with Rebinyn®. 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.
  • Inhibitors: The formation of inhibitors (neutralizing antibodies) to Factor IX has occurred following Rebinyn®. If expected plasma factor IX activity levels are not attained, or if bleeding is not controlled as expected with the administered dose, perform an assay that measures Factor IX inhibitor concentration. Monitor all patients using clinical observations and laboratory tests for the development of inhibitors. Factor IX activity assay results may vary with the type of activated partial thromboplastin time reagent used.
  • Thrombotic Events: The use of Factor IX-containing products has been associated with thromboembolic 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: 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 previously treated patients in clinical trials (≥1%) were itching and injection site reactions. The most common adverse reactions (≥1%) in previously untreated patients reported in clinical trials were rash, FIX inhibitors, hypersensitivity, itching, injection site reaction, and anaphylactic reaction.
  • Animals administered Rebinyn® showed accumulation of PEG in the choroid plexus, pituitary, circumventricular organs, and cranial motor neurons. The potential clinical implications of these animal findings are unknown. Consider whether the patient is vulnerable to cognitive impairment, such as infants and children who have developing brains, and patients who are cognitively impaired.

Please click here for Rebinyn® Prescribing Information.

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 (congenital Factor IX deficiency) for on demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. 

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

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 (congenital Factor IX deficiency) for on demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. 

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

Important Safety Information for Rebinyn®

Contraindications

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

Warnings and Precautions

  • Hypersensitivity Reactions: Allergic-type hypersensitivity reactions, including anaphylaxis, have occurred with Rebinyn®. 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.
  • Inhibitors: The formation of inhibitors (neutralizing antibodies) to Factor IX has occurred following Rebinyn®. If expected plasma factor IX activity levels are not attained, or if bleeding is not controlled as expected with the administered dose, perform an assay that measures Factor IX inhibitor concentration. Monitor all patients using clinical observations and laboratory tests for the development of inhibitors. Factor IX activity assay results may vary with the type of activated partial thromboplastin time reagent used.
  • Thrombotic Events: The use of Factor IX-containing products has been associated with thromboembolic 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: 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 previously treated patients in clinical trials (≥1%) were itching and injection site reactions. The most common adverse reactions (≥1%) in previously untreated patients reported in clinical trials were rash, FIX inhibitors, hypersensitivity, itching, injection site reaction, and anaphylactic reaction.
  • Animals administered Rebinyn® showed accumulation of PEG in the choroid plexus, pituitary, circumventricular organs, and cranial motor neurons. The potential clinical implications of these animal findings are unknown. Consider whether the patient is vulnerable to cognitive impairment, such as infants and children who have developing brains, and patients who are cognitively impaired.

Please click here for Rebinyn® Prescribing Information.

References:

  1. 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.
  2. Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc.
  3. 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.
  4. Tiede A, Abdul-Karim F, Carcao M, et al. Pharmacokinetics of a novel extended half-life glycoPEGylated factor IX, nonacog beta pegol (N9-GP) in previously treated patients with haemophilia B: results from two phase 3 clinical trials. Haemophilia. 2017;23(4):547-555.
  5. Novo Nordisk A/S. Safety of 40K PEGylated recombinant Factor IX in non-bleeding patients with haemophilia B. ClinicalTrials.gov identifier: NCT00956345. Updated January 20, 2017. Accessed June 3, 2022. https://clinicaltrials.gov/ct2/show/NCT00956345
For Health Care Professionals
  • Rare Bleeding Disorders Home
  • Product Information
    Products
    • Our Treatments
      How to Order
      Trial Prescriptions
      Recombinant Manufacturing
    Professional Resources
    • Product Resources Library
      Contact Your Representative
  • Professional Education
    Disease Education
    • Clinical Education Library
      Congenital Hemophilia with Inhibitors
      Breakthrough Bleeds
      Acquired Hemophilia
      Glanzmann's Thrombasthenia
      Interactive Joint Bleed Model
    Treatment Guidelines
    • MASAC Guidelines
      WFH Guidelines
    Additional Resources
    • Organizations & Conferences
  • Patient Support
    Product Education
    • Product Education Materials
    Disease Education
    • Disease Education Resources
    Access & Affordability
    • Prescription Savings & Insurance Support
      ICD-10 Codes for Rare Bleeding Disorders

Rebinyn® is a registered trademark and novoMEDLINK™ is a trademark of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
All other trademarks, registered or unregistered, are the property of their respective owners.
Non-US Health Care Professionals, please go to pro.novonordisk.com.

Terms of Use | Privacy Notice | Consumer Health Privacy Notice | Cookie Notice | Privacy Request | Contact Us |
novonordisk-us.com    
© 2025 Novo Nordisk All rights reserved. US25REB00006 May 2025

What can we help you do today?

Quick links

Trial prescription programs

Patient access and affordability options

MASAC treatment guidelines

Patient educational materials

Medical Information     |     Non-US Health Care Professionals