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See the data that helped her decide.

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

Rebinyn^® helps pediatric patients achieve and maintain high factor levels^1,a

It’s why Emili, patient advocate and parent to Xander, chose Rebinyn^® to treat his bleeds with mild hemophilia B.

One dose of Rebinyn^® 40 IU/kg elevated factor levels above normal in children up to age 6 years^a

Snapshot of Emili, an advocate for Rebinyn® [Rebinyn Coagulation Factor IX (Recombinant), GlycoPEGylated ] kneeling next to her son Xander, who has mild hemophilia B. They are smiling and happy.

+60^%		increase in plasma concentration of factor after an infusion^b
8^%		factor activity sustained after 7 days (n=12)^a

See the Data

^aBased on pharmacokinetic assessment of a single dose of Rebinyn^® 40 IU/kg after 7 days in 3 adolescents (mean FIX activity 14.6%), 13 children aged 7 to 12 (mean FIX activity 10.9%), and 12 children aged 0-6 (mean FIX activity 8.4%) upon enrollment in the phase 3 trials using 1-stage assay and product-specific standard. All values are geometric mean.¹

^bBased upon a 1.51% increase in factor levels per IU/kg infused in children aged ≤6.¹

Scroll and review the results in older children.

Selected Important Safety Information

Contraindications

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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.

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A single dose of Rebinyn^® is all it takes

A 40 IU/kg dose of Rebinyn^® elevated factor levels above normal in pediatric patients.^a

The numbers speak for themselves:

In children aged 7–12 years

+64^%		increase in plasma concentration of factor after an infusion^c
11^%		factor activity sustained after 7 days^a (n=13)

In adolescents aged 13–17 years

+78^%		increase in plasma concentration of factor after an infusion^d
15^%		factor activity sustained after 7 days^a (n=3)

^cBased upon a 1.59% increase in factor levels per IU/kg infused in children aged 7-12.¹

^dBased upon a 1.96% increase in factor levels per IU/kg infused in adolescents aged 13-17.¹

See how Rebinyn^® measures up with other FIX treatments.

Compare Rebinyn^®

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

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

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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.

Reference:

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

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