| See and compare PK results for bleed control. |
View online |
|
|
|
|
|
|
 |
| Indicated for use in adults and children with hemophilia B for on-demand treatment and control of bleeding episodes, perioperative management of bleeding. |
|
|
|
| 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 |
|
|
|
| Mild to Moderate Bleeds: |
| A single dose of Rebinyn® predicted |
 |
|
|
|
|
|
| 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). |
|
| 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. |
|
|
| 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 |
 |
|
|
|
| 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 |
|
|
|
|
| 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 |
|
|
|
| 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. |
|
|
| 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 |
|
| Have you created an account on the new novoMEDLINK™? |
 |
| Keep up with important information about bleeding disorders treatments. |
| Receive the latest bleeding disorders news from Novo Nordisk. |
| Download, order, and share educational materials for you and your patients. |
|
|
|
|
| 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 |
| • |
|
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. |
|
|
| 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. |
|
| 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, the sponsor of this content, click here to unsubscribe. You also may call Novo Nordisk at 1.877.744.2579 or send 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 the Privacy Statement. |
|
Rebinyn® is a registered trademark of Novo Nordisk Health Care AG.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2021 Novo Nordisk All rights reserved. US21REB00013 July 2021 |
 |
|
|
|
