| Once-weekly Factor IX therapy for your hemophilia B patients. |
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, and routine prophylaxis to reduce the frequency of bleeding episodes. See Limitations of Use below. |
|
|
|
Rebinyn® is
now FDA approved
for prophylaxis |
|
| Now your patients with hemophilia B have a new option for once-weekly prophylactic treatment. See how Rebinyn® is raising expectations with higher FIX levels for longer.1,a |
|
| Review the Prescribing Information to learn more. |
|
|
|
| aBased 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. Estimated mean PK parameters are adjusted to a dose of 50 IU/kg. Incremental recovery at 30 minutes (IR30) and half-life were higher and longer with Rebinyn® than rFIX (IR30 0.0131 vs 0.0068 (IU/mL)/(IU/kg) and half-life 93 vs. 19 hours). (All values were statistically significant (P< 0.001).) The clinical relevance of these PK differences is unknown.1 |
| Want to learn more about Rebinyn® prophylaxis? |
| Sign up for novoMEDLINK™ to be first to know about product and indication updates for your patients. |
|
|
|
| Scroll to schedule a meeting with a representative. |
 |
|
| 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: Allergic-type hypersensitivity reactions, including anaphylaxis, have occurred with Rebinyn®. 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. |
|
|
| Have questions about Rebinyn®? |
| Connect with your Hemophilia Therapy Manager to explore product resources for you and your patients. |
|
|
|
| |
| Clinical product information |
| Trial prescriptions |
| Hemophilia education for patients |
| Resources for starting treatment |
| General questions and inquiries |
|
|
|
|
| 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 (congenital Factor IX deficiency) for on demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. |
| Limitations of Use: Rebinyn® is not indicated for immune tolerance induction in patients with hemophilia B. |
| Important Safety Information (cont’d) |
| Warnings and Precautions |
| • |
|
Inhibitors: The formation of inhibitors (neutralizing antibodies) to Factor IX has occurred following Rebinyn®. If expected plasma factor IX activity levels are not attained, or if bleeding is not controlled as expected with the administered dose, perform an assay that measures Factor IX inhibitor concentration. Monitor all patients using clinical observations and laboratory tests for the development of inhibitors. Factor IX activity assay results may vary with the type of activated partial thromboplastin time reagent used. |
|
| • |
|
Thrombotic Events: The use of Factor IX-containing products has been associated with thromboembolic 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: 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 previously treated patients in clinical trials (≥1%) were itching and injection site reactions. The most common adverse reactions (≥1%) in previously untreated patients reported in clinical trials were rash, FIX inhibitors, hypersensitivity, itching, injection site reaction, and anaphylactic reaction. |
|
| • |
|
Animals administered Rebinyn® showed accumulation of PEG in the choroid plexus, pituitary, circumventricular organs, and cranial motor neurons. The potential clinical implications of these animal findings are unknown. Consider whether the patient is vulnerable to cognitive impairment, such as infants and children who have developing brains, and patients who are cognitively impaired. |
|
| Please click here for Prescribing Information. |
|
|
| 1. |
Negrier C, Knobe K, Tiede A, et al. 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. |
|
|
<%@ 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 (eg, 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. |
|
Rebinyn® is a registered trademark and novoMEDLINK™ is a trademark of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2022 Novo Nordisk All rights reserved. US22REB00072 August 2022 |
 |
|
|
|
