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COMPARATIVE PK DATA: REBINYN® vs. OTHER FACTOR IX PRODUCTS

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

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COMPARE THE IMPROVED PK PROFILE OF REBINYN®

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

Markus lives with hemophilia B and still goes camping

Use our interactive PK Modeling Tool to predict FIX activity of Rebinyn® compared with standard half-life (SHL) factor IX products. See plasma activity, WFH target factor IX levels, total dosage, and total infusions required for a range of bleed types: mild to moderate, severe, surgical use, or intracranial hemorrhages.

WFH=World Federation of Hemophilia

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COMPARED WITH SHL, A SINGLE DOSE OF REBINYN® WAS PREDICTED TO CONTROL A MILD TO MODERATE BLEED

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

WFH=World Federation of Hemophilia

COMPARED WITH SHL, A SINGLE DOSE OF REBINYN® WAS PREDICTED TO CONTROL A SEVERE BLEED

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

WFH=World Federation of Hemophilia

COMPARED WITH SHL, AN INITIAL DOSE OF REBINYN® WAS PREDICTED TO MAINTAIN FIX LEVELS IN SURGERY

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

WFH=World Federation of Hemophilia

COMPARED WITH SHL, FEWER DOSES OF REBINYN® WERE PREDICTED TO CONTROL FIX LEVELS IN INTRACRANIAL HEMORRHAGE

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

WFH=World Federation of Hemophilia

Use our interactive PK Modeling Tool to predict FIX activity of Rebinyn® compared with an extended half-life (EHL) factor IX product. See plasma activity, WFH target factor IX levels, total dosage, and total infusions required for a range of bleed types: severe, surgical use, or life-threatening bleeds. 

WFH=World Federation of Hemophilia

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COMPARED WITH EHL rFIXFc, A SINGLE DOSE OF REBINYN® WAS PREDICTED TO CONTROL A SEVERE BLEED

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

COMPARED WITH EHL rFIXFc, AN INITIAL DOSE OF REBINYN® WAS PREDICTED TO MAINTAIN FIX LEVELS IN SURGERY

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

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

WFH=World Federation of Hemophilia

COMPARED WITH EHL rFIXFc, FEWER DOSES OF REBINYN® WERE PREDICTED TO CONTROL FIX LEVELS IN LIFE-THREATENING BLEEDS

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

WFH=World Federation of Hemophilia

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

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

Estimated number of doses and amount of FIX per episode1,2,a-c

aA single dose should be sufficient for minor and moderate bleeds. Additional doses of 40 IU/kg can be given.3
bBased 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
cBased on PK modeling to WFH guidelines. Simulated results based on phase 1 PK study of Rebinyn® (n=15).2

HIGH FACTOR ACTIVITY

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Studies show Rebinyn® elevates factor levels.2

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IS REBINYN® RIGHT FOR YOUR PATIENTS?

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Our FIX comparison guide highlights storage conditions and more.

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HIGH FACTOR ACTIVITY

Studies show Rebinyn® elevates factor levels.2
 

   See the Data   

IS REBINYN® RIGHT FOR YOUR PATIENTS?

Our FIX comparison guide highlights storage conditions and more.
 

   Compare at a Glance   

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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.

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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; May 2017.