| See and compare PK results for bleed control. |
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| Indicated for use in adults and children with hemophilia B for on-demand treatment and control of bleeding episodes, perioperative management of bleeding. |
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| See How Rebinyn® Offers Your Patients Bleed Control. |
| Pharmacokinetic simulations predicted that a single 40 IU/kg dose of Rebinyn® would control mild to moderate bleeds by providing Factor IX levels above 40% for an average of 23 hours.1 |
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| Mild to Moderate Bleeds: |
| A single dose of Rebinyn® predicted |
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| 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 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). |
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| Scroll to see results for other bleeding scenarios. |
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| 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. |
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| 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. |
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| What About Severe Bleeds? |
| According to the same PK simulations, a single 80 UI/kg dose of Rebinyn® was predicted to control a severe bleed by providing FIX levels above 50% for an average of 3 days.1 |
| A single dose of Rebinyn® predicted |
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| Even in Surgery? |
| The pharmacokinetic simulations predicted that an initial 80 IU/kg dose of Rebinyn®, followed by two 40 IU/kg doses at 5 and 10 days postoperatively, would maintain target FIX levels for 2 weeks after surgery.1,c,d |
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| cAfter initial dose of 80 IU/kg for major surgery, 40 IU/kg is recommended at 1-3 day intervals within the first week as clinically needed. Frequency may be extended to once weekly after the first week until bleeding stops and healing is achieved.3 |
| dWFH guidelines define target FIX levels to be above 40 IU dL-1 for 3 days, above 30 IU dL-1 for a further 3 days, and then above 20 IU dL-1 until 14 days.1 |
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| Illustrative patient cases |
| Longer-lasting factor activity and 4-minute infusions may help patients with a variety of needs and goals.2,3,e Our patient profiles illustrate how Rebinyn® might factor into the lives of patients like yours. |
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| eBased 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 recombinant FIX (rFIX) (n=7) or plasma-derived FIX (pdFIX) (n=8) using a 1-stage assay and product-specific standard. For Rebinyn®, estimated mean activity is adjusted to a dose of 50 IU/kg. Differences in comparison of Rebinyn® and rFIX were: recovery 1.3 to 0.68 IU/dL per IU/kg, 2x; half-life 93 vs 19 hours, 4.9x; area under the curve 72 vs 7 U x h/mL, 10x. 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; area under the curve 70 vs 9 U x h/mL, 8x).2 |
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| Keep up with important information about bleeding disorders treatments. |
| Receive the latest bleeding disorders news from Novo Nordisk. |
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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 |
| Warnings and Precautions |
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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. |
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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). |
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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. |
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| Adverse Reactions |
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The most common adverse reactions reported in clinical trials (≥1%) were itching and injection site reactions. |
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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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| Please click here for Prescribing Information. |
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| 1. |
Collins PW, Moss 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;10:2305–12. |
| 2. |
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. |
| 3. |
Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc; June 2020. |
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