Colin, 46
Severe hemophilia B
- Experiences joint pain and swelling
- Discomfort can last 1-3 days after a bleed
- Pain sometimes limits his activities
- Looking for a treatment that keeps his FIX levels in the non-hemophilia range as long as possible
How could Rebinyn® prophylaxis help Colin?
With effective bleed prevention and once-weekly dosing,1 Rebinyn® prophylaxis may be a good fit for Colin’s lifestyle.
Landen, 31
Moderate hemophilia B
- Active, busy, travels for work
- Multiple infusions per week often required with current SHL FIX
- Bleeding episodes can take up to 3 days to control
- Wants to minimize impact of treatment on his life
Would Rebinyn® prophylaxis be appropriate for Landen?
Flexible storage helps with traveling, and once-weekly dosing may help reduce infusions and impact on his routine.
Alex, 28
Moderate hemophilia B
- Active, but worries about long-term joint damage; starting to cut back on physical activity
- Wants to feel like he’s protected when active
- Interested in trying other treatments
Would Rebinyn® be appropriate for Alex?
Higher factor levels for longer2,a could be useful when deciding between EHL options.
Karla, 17
Mild hemophilia B
- Works part-time and goes to school
- Worries about breakthrough bleeds affecting her routine
- Seeking an option that keeps her factor levels high to be prepared the unexpected
Is Rebinyn® right for Karla?
High factor activity that lasts longer than Alprolix®, and trough levels that are 6 times higher than Alprolix® at the end of the dosing interval, may fit her busy lifestyle.3,b
aBased 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 pharmacokinetic (PK) parameters are adjusted to a dose of 50 IU/kg. Incremental recovery at 30 minutes (IR30) and half-life were higher and longer with Rebinyn® than rFIX (IR30 0.0131 vs 0.0068 (IU/mL)/(IU/kg) and half-life 93 vs 19 hours). (All values were statistically significant (P<0.001).) The clinical relevance of these PK differences is unknown.2
bBased 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
Juanita, mom of Oliver, 8
Severe hemophilia B
- Still learning how to handle Oliver’s bleeding episodes
- Anxious about potential surgeries when he is older
- Putting off his dental work due to concerns about bleeds
- Wants to do whatever possible to help protect his joints and allow him to participate in activities
What does Rebinyn® offer Juanita and Oliver?
High intraoperative success rate1,c and sustained FIX levels4 may satisfy her concerns and his needs.
cEfficacy analysis included adults and adolescents.1
Have questions about how Rebinyn® can help your patients?
Patient Trial Program
Considering Rebinyn® for your patients with hemophilia B?
To learn more about our Patient Trial Program, please call 1-844-668-6732 to speak with a NovoCare® Specialist.
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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: 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.
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
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.
- 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 Rebinyn® Prescribing Information.
References:
- Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2022.
- Negrier C, Knobe K, Tiede A, et al. 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.
- 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.
- 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.