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COMPARATIVE PK DATA: REBINYN® vs. SHL AND EHL FIX PRODUCTS

See modeling data that may help when considering treatment options

Leopoldo lives with hemophilia B
Leopoldo lives with hemophilia B

Considering FIX treatment options? Rebinyn® may provide higher factor levels for longer.

Leopoldo lives with hemophilia B
Leopoldo lives with hemophilia B

INTERACTIVE PK MODELING TOOL

Use this tool to see predicted FIX activity for Rebinyn® compared with standard half-life (SHL) or extended half-life (EHL) factor products: 

  • Launch the SHL or EHL tool
  • Choose from a range of bleed types: mild to moderate, severe, surgical use, or intracranial hemorrhage
  • Click to see predicted plasma activity, WFH target FIX levels, total dosage, and number of infusions required

WFH=World Federation of Hemophilia


        For illustrative purposes only.

ADDITIONAL PREDICTIVE PK DATA

PREDICTIVE PK DATA

MILD TO MODERATE BLEED—CONTROLLED WITH A SINGLE DOSE OF REBINYN®

Compared with SHL, a single 40 IU/kg dose of Rebinyn® was predicted to provide FIX levels above 40% for an average of 23 hours using PK simulations.1

1 dose of Rebinyn® vs 2 doses of SHL rFIX or pdFIX were required to maintain the same WFH target FIX activity level.1

SEVERE BLEED—CONTROLLED WITH 1 DOSE OF REBINYN® vs 6 DOSES OF SHL

A single 80 IU/kg dose of Rebinyn® was predicted to provide FIX levels above 50% for an average of 3 days using PK simulations.1

1 dose of Rebinyn® vs 6 doses of SHL rFIX or pdFIX were required to maintain the same WFH target FIX activity level.1

SURGERY—AN INITIAL DOSE OF REBINYN® MAINTAINED FIX LEVELS vs SHL

A single 80 IU/kg dose of Rebinyn®, followed by two 40 IU/kg doses, was predicted to maintain target FIX levels for a 2-week postoperative period using PK simulations.1

3 doses of Rebinyn® vs 17 doses of SHL rFIX or pdFIX were required to maintain the same WFH target FIX activity level.1

INTRACRANIAL HEMORRHAGE—REBINYN® CONTROLLED FIX LEVELS WITH 5 DOSES vs. 28 FOR SHL

A single 80 IU/kg dose of Rebinyn®, followed by four 40 IU/kg doses, was predicted to maintain target FIX levels for a 3-week postoperative period using PK simulations.1

5 doses of Rebinyn® vs 28 doses of SHL rFIX or pdFIX were required to maintain the same WFH target FIX activity level.1

SEVERE BLEED—CONTROLLED WITH 1 DOSE OF REBINYN® VS 4 DOSES OF ALPROLIX®

A single 80 IU/kg dose of Rebinyn® was predicted to provide FIX levels above 50% for an average of ≈5 days using PK simulations.2

1 dose of Rebinyn® vs 4 doses of EHL rFIXFc were required to maintain the same WFH target FIX activity level.2

WFH=World Federation of Hemophilia

MAJOR SURGERY—AN INITIAL DOSE OF REBINYN® MAINTAINED FIX LEVELS

Compared with EHL, a single 80 IU/kg dose of Rebinyn®, followed by two 40 IU/kg doses, was predicted to maintain target FIX levels for a 2-week postoperative period using PK simulations.2,a

aAn 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).

3 doses of Rebinyn® vs 9 doses of EHL rFIXFc were required to maintain the same WFH target FIX activity level.2

LIFE-THREATENING BLEED—CONTROLLED WITH FEWER DOSES OF REBINYN®

Compared with EHL, a single 80 IU/kg dose of Rebinyn®, followed by four 40 IU/kg doses, was predicted to maintain target FIX levels for a 3-week postoperative period using PK simulations.2

5 doses of Rebinyn® vs 11 doses of EHL rFIXFc were required to maintain the same WFH target FIX activity level.2


REBINYN® MAY REDUCE THE NEED FOR ADDITIONAL INFUSIONS1,2,a-c

Based on pharmacokinetic (PK) modeling, Rebinyn® required fewer infusions per episode than SHL and EHL FIX products.


Select a bleed type
to see an estimated number of doses and amount of FIX per episode.1,2,b-d

Estimated number of doses and amount of FIX per episode1,2,b-d

Estimated number of doses and amount of FIX per episode1,2,b-d

Estimated number of doses and amount of FIX per episode1,2,b-d

Estimated number of doses and amount of FIX per episode1,2,b-d

Estimated number of doses and amount of FIX per episode1,2,b-d

bA single dose should be sufficient for minor and moderate bleeds. Additional doses of 40 IU/kg can be given.3
cBased on PK modeling to World Federation of Hemophilia (WFH) guidelines. Simulated results based on phase 1 PK studies of Rebinyn® (n=30), recombinant FIX (rFIX) (n=7), and plasma-derived FIX (pdFIX) (n=8), and rFIXFc (n=15).1,2
dAn 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).3

SIMPLIFIED DOSING AND MORE

Syringe

Our FIX comparison guide highlights dosing, storage conditions, and more.

IS REBINYN® RIGHT FOR YOUR PATIENTS?

Rebinyn® patient outline

Find out more about what’s important to patients when they’re considering a switch.

SIMPLIFIED DOSING AND MORE

Our FIX comparison guide highlights dosing, storage conditions, and more.

IS REBINYN® RIGHT FOR YOUR PATIENTS?

Find out more about what’s important to patients when they’re considering a switch.
 

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. 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.
  2. 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.
  3. Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc; June 2020.