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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.
Single-dose Rebinyn® provided higher incremental recovery, longer half-life, and greater area under the curve (AUC) compared to other SHL and EHL treatments.1-3,a,b
Rebinyn® vs. BeneFIX®a
aThe clinical relevance of these PK differences is unknown.
bPhase 1 trial comparing PK of Rebinyn® with SHL FIX products (Negrier, et al). Based upon a phase 1 study of patients administered 1 of 3 doses of Rebinyn® (25, 50, or 100 IU/kg) compared with 1 dose of their prior SHL rFIX (n=7) or pdFIX (n=8) at the same dose using a 1-stage assay. Estimated mean PK parameters were adjusted to a dose of 50 IU/kg. Differences were similar in comparison of Rebinyn® to pdFIX (half-life 93 vs 18 hours, 5.2x; P<0.001; AUC 70 vs 9 U x h/ml, 8x, P<0.001) and in comparison of Rebinyn® to rFIX (half-life 93 vs 19 hours, P<0.001; AUC 72 vs 7 U x h/ml, P<0.001). The clinical relevance of these PK differences is unknown.1
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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.
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Higher factor levels for longer with Rebinyn®.
Single-dose Rebinyn® allowed patients to achieve and maintain a higher factor level for longer compared with Alprolix®.3,c,d
Rebinyn® vs. Alprolix®b
cThe clinical relevance of these PK differences is unknown.
dPhase 1 trial comparing PK of Rebinyn® with Alprolix® (Ettingshausen, et al). Based upon a phase 1 study of 15 patients administered a single dose of Rebinyn® 50 IU/kg compared with a single dose of Alprolix® 50 IU/kg using both 1-stage and chromogenic assays. The standard Alprolix® dose of 50 IU/kg was administered for both products to allow for comparison of dose-dependent parameters; dose normalized to 50 IU/kg to reflect minor differences in dose administered. Geometric mean half-life was also prolonged (Rebinyn®: 103.2 hours, Alprolix®: 84.9 hours). All comparisons were significant (P<0.0001) for all assays. The clinical relevance of these PK differences is unknown.3
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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.
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References:
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.
2. Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2022.
3. Ettingshausen C, Hegemann I, Simpson M, et al. Favorable pharmacokinetics in hemophilia B for nonacog beta pegol versus recombinant factor IX-Fc fusion protein: a randomized trial. Res Pract Thromb Haemost. 2019;3(2):268–276.
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