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Important Safety Information  |  Prescribing Information
Rebinyn® Coagulation IX factor (Recombinant), GlycoPEGylated.
Indicated for use in adults and children with hemophilia B for on-demand treatment and control of bleeding episodes, perioperative management of bleeding.
Compare Rebinyn® PK data to Alprolix® for your hemophilia B patients
Compared to Alprolix, Rebinyn® provides higher FIX activity and maintains it for longer.a
 Assess PK Data 
icon depicting a Rebinyn® vial vs. an Alprolix vial.
icon depicting a Rebinyn® vial vs. an Alprolix vial.
 Assess PK Data 
aBased 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 1-stage (shown above) 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<0.0001) for all assays.1
Scroll to see results for other bleeding scenarios.
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.
Calculate desired FIX levels? No need with Rebinyn®.
Rebinyn®
icon depicting a vial with large text reading “40IU/kg,” the recommended Rebinyn® dose for minor or moderate bleeds.
The recommended dose for all patients is 40 IU/kg for minor or moderate bleeds
80 IU/kg for major bleeds2,b
 
Alprolix
icon depicting a vial and a calculator. The screen on the calculator reads ‘?.’
Dosing calculation required, based on3:
• Severity of FIX deficiency
• Patient’s pharmacokinetic profile
• Location and extent of bleeding
bA single dose should be sufficient for minor and moderate bleeds. Additional doses of 40 IU/kg can be given.
 See Dosing for Rebinyn® 
Improved PK profile compared with BeneFIX® and Alprolix.
In 2 Phase 1 studies, Rebinyn® was shown to achieve and maintain a 5x longer half-life than BeneFIX and a 4x greater factor activity level than Alprolix.4,5
5 x
longer half-life compared
with BeneFIX4,c
Rebinyn®:
93   hours
BeneFIX:
19   hours
 
4 x
greater AUC compared
with Alprolix5,a
P<0.0001
Rebinyn®:
96.6   (IU x h/mL)
Alprolix:
22.0   (IU x h/mL)
• The clinical relevance of these PK differences is unknown
• Rebinyn® is not approved for routine prophylaxis
• Animals given repeat doses of Rebinyn® showed accumulation of PEG in the choroid plexus. The potential clinical implications of these animal findings are unknown2
In a phase 3 study, Rebinyn® achieved an 83-hour mean half-life in adults.2,d
 Review PK Data 
cBased upon a phase 1 study of patients administered one of three doses of Rebinyn® (25, 50, or 100 IU/kg) compared with one dose of their prior SHL rFIX (n=7) or pdFIX (n=8) at the same dose using a one-stage assay and product-specific standard. For Rebinyn®, estimated mean activity is adjusted to a dose of 50 IU/kg. Differences were similar in comparison of Rebinyn® to pdFIX (recovery 1.3 vs 1.1 IU/dL per IU/kg, 1.2x; half-life 93 vs 18 hours, 5.2x; AUC 70 vs 9 U x h/mL, 8x).4
dBased upon pharmacokinetic assessment of a single dose of Rebinyn® 40 IU/kg upon enrollment in two phase 3 studies using one-stage assay and product-specific standard. For 6 adults (mean FIX activity 7 days after dosing: 16.8%), recovery is based upon 2.34% increase in factor levels per IU/kg infused in adults. Assessments were also completed in 3 adolescents (mean FIX activity 7 days after dosing: 14.6%), 13 children ages 7 to 12 (mean FIX activity 7 days after dosing: 10.9%) and 12 children ages 0-6 (mean FIX activity 7 days after dosing: 8.4%). All values are geometric mean.2
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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. Ettingshausen C, Hegemann I, Simpson M, 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;3(2):268-276.
2. Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; June 2020.
3. Alprolix [package insert]. Cambridge, MA: Biogen Inc.; 2020.
4. 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.
5. 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.
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