Achieve high factor activity across age groups
Rebinyn® helps adults, adolescents, and children achieve high factor levels.1,a
Achieve high factor activity across age groups
Rebinyn® helps adults, adolescents, and children achieve high factor levels.1,a
Take control with high factor activity
In paradigm 2, a phase 3 clinical trial, Rebinyn® elevated factor levels above baseline levels, with +94% achieved after an infusion in adults1,a and 17% sustained after 7 days in adults.1
achieved after an infusion1,a
sustained after 7 days1
With a single dose of Rebinyn® 40 IU/kg in adults with ≤2% factor levels1
aBased upon a 2.34% increase in factor levels per IU/kg infused in adults.
In the phase 3 study, Rebinyn® achieved an 83-hour mean half-life in adults.1
Do you see teens like Karla?
Karla is 17 and lives with mild hemophilia B. Learn more about what patients like her are looking for in a factor IX treatment.
For illustrative purposes.
Pediatric patients showed elevated factor activity in pivotal clinical trials
In paradigm 2 and paradigm 5, a single dose of Rebinyn® 40 IU/kg elevated factor levels above baseline in children and adolescents aged 17 and younger.1-3
age 6 and below
achieved after
an infusion1,b
sustained after 7 days1
n=12
age 7-12
achieved after
an infusion1,c
sustained after 7 days1
n=13
age 13-17
achieved after
an infusion1,d
sustained after 7 days1
n=3
bBased upon a 1.51% increase in factor levels per IU/kg infused in children aged ≤6.1
cBased upon a 1.59% increase in factor levels per IU/kg infused in children aged 7-12.1
dBased upon a 1.96% increase in factor levels per IU/kg infused in adolescents aged 13-17.1
Study designs
paradigm 2: pivotal phase 3 clinical trial in adults and adolescents (Collins, et al.)
Based upon pharmacokinetic assessment of a single dose of Rebinyn® 40 IU/kg upon enrollment using one-stage assay and product-specific standard. For 6 adults (mean FIX activity after 7 days: 16.8%), recovery is based upon 2.34% increase in factor levels per IU/kg infused in adults. Assessments were also completed in 3 adolescents (mean FIX activity after 7 days: 14.6%).1
Bleed control results shown are from the on-demand arm of the adolescent/adult trial, in which 15 previously treated adolescent/adult subjects were treated for on-demand bleeds. In 14 subjects, there were a total of 143 bleeding episodes. In 1 subject, no bleeding episode data were recorded.1,3
paradigm 5: phase 3 clinical trial in children (aged ≤12 years) (Carcao, et al)
Results shown from an international, multicenter, open-label, non-controlled, single-arm trial designed following EMA guidelines. Patients were stratified into two age groups: 0–6 years and 7–12 years. The trial consisted of a main phase of 52 weeks, and an extension phase, which is still ongoing. All patients received a fixed dose of 40 IU/kg of Rebinyn® intravenously once weekly for prophylaxis. A PK assessment was conducted after the first dose of Rebinyn®, with the last PK sample collected right before the second dose was administered 1 week afterward. Breakthrough bleeds were treated with a single dose of 40 IU/kg of Rebinyn® (mild-to-moderate bleeds) or 80 IU/kg of Rebinyn® (severe bleeds).2
Tools to help you compare PK of FIX products
Explore modeling data comparing Rebinyn® with SHL and EHL FIX products.
Simplified dosing
Fixed dosing for all patients means no calculating desired FIX activity levels.1
Selected Important Safety Information for Rebinyn®
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.
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
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.
- 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 Rebinyn® Prescribing Information.
References:
- Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc; June 2020.
- Carcao M, et al. The Long-term safety and efficacy of nonacog beta pegol (n9-gp) administered for at least 5 years in previously treated children with hemophilia B. Thomb Haemost. 2020; 120(5):737-746).
- Collins PW, Young G, Knobe K, et al; paradigm 2 Investigators. Recombinant long-acting glycoPEGylated factor IX in hemophilia B: a multinational randomized phase 3 trial. Blood. 2014;124(26):3880-3886.