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Important Safety Information  |  Prescribing Information
Rebinyn® Coagulation Factor IX (Recombinant), GlycoPEGylated logo.
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.
Your patients can reach the non-hemophilia range
The World Federation of Hemophilia (WFH) acknowledges extended half-life FIX products can allow for a more ambitious prophylaxis by having patients’ FIX levels in a non-hemophilic range (>40%) for a substantial proportion of time.1
  With Rebinyn®, your adult and
adolescent patients can spend
 
~ 80 %
  of the dosing interval
  with factor levels in the
non-hemophilia range
(factor levels above 40%)2,a
Image of a male figure facing the camera.
Image of a male figure facing the camera.
aData 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 9 levels were within the non-hemophilia range (greater than 40%) for 5.4 days (approximately 80% of the week).
 See the Data 
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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.
 
 
High FIX levels with once-weekly dosing3
Rebinyn® prophylaxis can provide high incremental recovery, elevated factor levels, long half-life, and time in the non-hemophilia range for most of the week.3,a-c
Chart depicting the non-hemophilia range percentage.
Chart depicting the non-hemophilia range percentage.
bBased on analysis using a 1-stage assay in patients N=6, age ≥18 the half-life at steady state was 115 hours following once-weekly (40 IU/kg) dosing, in patients N=3, age 13-17 the half-life at steady state was 103 hours. Following single-dose administration (40 IU/kg) in the same patient population, the half-life was 83 hours (adults) and 89 hours (adolescents).
cData 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 9 levels were within the non-hemophilia range (greater than 40%) for 5.4 days (approximately 80% of the week).
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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
•   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.
References:
1. Srivastava A, Santagostino E, Dougall A, et al. WFH guidelines for the management of hemophilia. Haemophilia. 2020;26(suppl 6):1-158.
2. 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.
3. Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2022.
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