| Compare this hemophilia B therapy with other treatments. |
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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, and routine prophylaxis to reduce the frequency of bleeding episodes. See Limitations of Use below. |
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| Would a switch to Rebinyn® prophylaxis help your patients living with hemophilia B? |
| Rebinyn® can help a range of hemophilia B patients. They may be interested in treatments to keep them in the non-hemophilia range for as long as possible. |
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| Rebinyn® could help patients like yours who may be considering a therapy switch. |
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to learn about FIX
levels with Rebinyn®. |
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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 |
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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. |
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| Please click here or scroll below for additional Important Safety Information. |
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| Higher factor levels for longer with Rebinyn®. |
| Rebinyn® once-weekly helps adults and adolescents maintain FIX levels in the non-hemophilia range for most of the week.1,b |
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| Adult and adolescent patients achieved FIX levels in the non-hemophilia range (n=9)2,b |
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| bData represent mean steady-state pharmacokinetic profiles from previously treated adolescent/adult patients with moderate to severe hemophilia B (n=9) taking Rebinyn® 40 IU/kg once weekly. Factor IX levels were within the non-hemophilia range (greater than 40%) for 5.4 days (approximately 80% of the week).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 (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 (cont'd) |
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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. |
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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). |
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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. |
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| Adverse Reactions |
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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. |
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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. |
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| Please click here for Prescribing Information. |
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| 1. |
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. |
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Tiede A, Abdul-Karim F, Carcao M, et al. Pharmacokinetics of a novel extended half-life glycoPEGylated factor IX, nonacog beta pegol (N9-GP) in previously treated patients with haemophilia B: results from two phase 3 clinical trials. Haemophilia. 2017;23(4):547-555. |
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