Comparing FIX PK activity: Rebinyn® vs. SHL and EHL
Rebinyn® provides higher incremental recovery, a longer half-life, and greater AUC than BeneFIX® or Alprolix®.1-3
Comparing FIX PK activity: Rebinyn® vs. SHL and EHL
Rebinyn® provides higher incremental recovery, a longer half-life, and greater AUC than BeneFIX® or Alprolix®.1-3
PK: Compare Rebinyn® with BeneFIX
In a phase 1 study, compared to BeneFIX, Rebinyn® was shown to1:
Increase FIX activity
Prolong time in the body
Keep FIX activity higher
aPer IU/kg.
b(IU x h/mL).
Rebinyn® achieved and maintained higher factor activity1
The estimated time to 1% with Rebinyn® was 22.5 days.1
- Rebinyn® is not approved for routine prophylaxis.2
- Animals given repeat doses of Rebinyn® showed accumulation of PEG in the choroid plexus. The potential clinical implications of these animal findings are unknown.2
PK: Compare Rebinyn® with Alprolix
In the paradigm 7 study, compared to Alprolix, Rebinyn® was shown to3:
Increase FIX activity
P<0.0001
Keep FIX activity higher
P<0.0001
Maintain FIX levels at 7 days
P<0.0001
cPer IU/kg.
dIU x h/mL.
Rebinyn® achieved and maintained higher factor activity3
The half-life of Rebinyn® was 103 hours vs. 85 hours for Alprolix.3
- The clinical relevance of these PK differences is unknown
- Rebinyn® is not approved for routine prophylaxis
Would a switch to Rebinyn® help a patient like Alex?
Alex is 28 and lives with moderate hemophilia B. He’s been thinking about aging, bleed protection, and long-term joint damage. Find out more about what patients like Alex look for when considering a therapy switch.
For illustrative purposes.
Study designs
paradigm 1: phase 1 trial comparing PK of Rebinyn® with SHL FIX products (Negrier, et al.)
Based 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 is 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; AUC 70 vs. 9 U x h/mL, 8x) and in comparison of Rebinyn® to rFIX (half-life 93 vs. 19 hours; AUC 72 vs. 7 U x h/mL).1
paradigm 7: phase 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 (shown above) 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.3
Tools to help you compare PK of FIX products
Explore PK modeling data comparing Rebinyn® with SHL and EHL FIX products.
Established safety profile
Clinical trials showed 0 inhibitors and thrombotic events in previously treated patients.2
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:
- 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.
- Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc; June 2020.
- 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.