Novo Nordisk

Compare AUCs to find the answer.

Questions about Rebinyn^®? Connect with us

Indicated for use in adults and children with hemophilia B for on-demand treatment and control of bleeding episodes, perioperative management of bleeding.

Compare the PK factor activity of Rebinyn^® with a leading SHL and EHL

Help your patients achieve and keep high Factor IX activity level. In two separate phase I PK studies, Rebinyn^® demonstrated greater AUC compared to BeneFIX^® and Alprolix^®.^1-2,a,b

See the Data

Illustration depicting three product vials: Rebinyn®, at left, with yellow label and a yellow circle around the vial; BeneFIX, center, with a gray label; and Alprolix®, right, with a gray label.

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.

Please click here or scroll below for additional Important Safety Information.

Standard half-life comparison

In a phase I PK comparison study, Rebinyn^® demonstrated 10x greater AUC than BeneFIX.^1,a

Compare AUC

Graphic indicating 10x area under the curve, with Rebinyn® at 72 IU x h/mL and BeneFIX at 7 IU x h/ML.

Graphic indicating 4x area under the curve, with Rebinyn® at 96.6 IU x h/mL and Alprolix at 22.0 IU x h/mL.

Extended half-life comparison

Another phase I PK comparison study showed the AUC of Rebinyn^® was 4x greater than that of Alprolix.^2,b

Compare AUC

•	The clinical relevance of these PK differences is unknown
•	Rebinyn^® is not approved for routine prophylaxis

^aBased 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 rFIX (BeneFIX, n=7) or pdFIX (n=8) using a one-stage assay and product-specific standard. For Rebinyn^®, estimated mean activity is adjusted to a dose of 50 IU/kg to allow for comparison of dose-dependent parameters. Comparisons above were significant (P<0.001). Differences were also seen between Rebinyn^® and pdFIX (AUC 70 vs 9 IU x h/mL, 8x, P<0.001).¹

^bBased 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 one-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 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<0.001) for both assays.²

Have you created an account on the new novoMEDLINK™?

Keep up with important information about treatments for hemophilia and rare bleeding disorders.

Receive the latest bleeding disorders news from Novo Nordisk.

Download, order, and share educational materials for you and your patients.

Create Your Account

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 (cont’d)

Warnings and Precautions

•

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.	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.	Escuriola Ettingshausen C, Hegemann I, Simpson ML, 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;00:1–9.

<%@ include view='hcpColoradoFooter' %>

Please do not respond to this email. If you would like to contact us, please click here or call 1-800-727-6500.

UNSUBSCRIBE NOTICE

If you no longer want to receive communications from Novo Nordisk, click here to unsubscribe. You also may call us at 1-877-744-2579 or send us a letter that includes your full contact information (e.g. name, email address, phone) to Novo Nordisk, 800 Scudders Mill Road, Plainsboro, New Jersey 08536. To better understand how Novo Nordisk values your privacy, see our Privacy Statement.