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PK DATA: REBINYN® vs. STANDARD HALF-LIFE FIX PRODUCTS

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

Markus lives with hemophilia B and still goes camping

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

Markus lives with hemophilia B and still goes camping

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

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

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

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

Based on a pharmacokinetic (PK) modeling, in comparisons of Rebinyn® with recombinant FIX (rFIX) and plasma-derived FIX (pdFIX), Rebinyn® required fewer infusions per episode for mild to moderate bleeds, severe bleeds, and during and after surgery.

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

aA single 40 IU/kg dose should be sufficient for minor and moderate bleeds. Additional doses of 40 IU/kg may be given.
bBased on a pharmacokinetic (PK) modeling to World Federation of Hemophilia (WFH) guidelines. Simulated results based on phase 1 PK study of Rebinyn® (n=15), recombinant FIX (rFIX) (n=7), and plasma-derived FIX (pdFIX) (n=8).
cCompared with SHL products.

HIGH FACTOR ACTIVITY

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Studies show Rebinyn® elevates factor levels.2

IS REBINYN® RIGHT FOR YOUR PATIENTS?

Rebinyn® dosing icon

Our FIX comparison guide highlights storage conditions and more.

HIGH FACTOR ACTIVITY

Studies show Rebinyn® elevates factor levels.2
 

IS REBINYN® RIGHT FOR YOUR PATIENTS?

Our FIX comparison guide highlights storage conditions and more.
 

REGISTER TO GET THE LATEST UPDATES ON REBINYN®

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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.

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