Achieve control when bleeds occur
Studies show Rebinyn® provided effective bleed control across age groups and protection during surgery with a single dose for adults and adolescents.1-3
Achieve control when bleeds occur
Studies show Rebinyn® provided effective bleed control across age groups and protection during surgery with a single dose for adults and adolescents.1-3
Rebinyn® offers effective bleed control across age groups
98% of bleeds in adults and adolescents treated with 1-2 infusions in paradigm 2 clinical trial1,2
N=143 bleeding episodes
95% of bleeds were rated as successful (defined as excellent or good) in adults and adolescents in paradigm 2 clinical trial1,2
N=142 bleeding episodes
93% of bleed control in children rated as successful (defined as excellent or good) in paradigm 5 clinical trial3
N=42 bleeding episodes
In all major surgeries studied in adults and adolescents1,4,a:
single pre-operative dose1
intraoperative success rate1
aMajor surgeries are classified as procedures where the body cavity is entered, mesenchymal barrier is crossed, fascial plane is opened, organ is removed, or where the normal anatomy is operatively altered.
See how an initial dose of Rebinyn® was predicted to maintain target FIX levels during major surgery.5
Factor IX activity sustained up to 48 hours postsurgery1,4
bRange shaded represents the normal population FIX activity range of 50% to 150%.6
Rebinyn® may help Juanita and Oliver
Juanita, whose son Oliver lives with hemophilia B, is concerned about the potential for bleeds during dental surgery. The surgical efficacy of Rebinyn® may make it a good fit for them.
For illustrative purposes.
Study designs
paradigm 2: pivotal phase 3 trial in adults and adolescents (Collins, et al.)
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.1,2
paradigm 3: phase 3 clinical trial evaluating major surgery (Escobar, et al.)
Results shown are from the major surgery trial, which included 13 previously treated adolescent and adult subjects. On the day of their respective surgeries, patients received 1 infusion of Rebinyn® 80 IU/kg. Postoperatively, subjects received infusions of Rebinyn® 40 IU/kg at the investigator’s discretion for up to 3 weeks after surgery. Across 13 surgical procedures (9 major)—which included 9 orthopedic, 1 gastrointestinal, and 3 oral cavity procedures—the hemostatic effect during surgery was evaluated on a 4-point scale of excellent, good, moderate, or poor. Treatment success was defined as excellent or good hemostasis.1,4
In the surgery study, mean FIX activity following an initial preoperative Rebinyn® 80 IU/kg dose in 13 procedures was assessed by one-stage assay with product-specific standard. At 8 and 24 hours, one subject who had no FIX activity measurement obtained was excluded. At 48 hours, 2 subjects who had no FIX activity measurement obtained were excluded and 4 subjects re-dosed prior to the second day after surgery for whom FIX activity at 24 hours were 84%, 112%, 131%, and 134%. The FIX activity at 48 hours reflects a measurement on the second day after surgery (range 47-57 hours).1,4
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).3
High factor activity
Studies show Rebinyn® elevates factor levels.1
Simplified dosing
Fixed dosing for all patients means no calculating desired factor IX 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; 2020.
- 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.
- Carcao M, Zak M, Abdul Karim F, et al. Nonacog beta pegol in previously treated children with hemophilia B: results from an international open-label phase 3 trial. J Thromb Haemost. 2016;14(8):1521-1529.
- Escobar MA, Tehranchi R, Karim FA, et al. Low-factor consumption for major surgery in haemophilia B with long-acting recombinant glycoPEGylated factor IX. Haemophilia. 2017;23(1):67-76.
- Simpson M, Kulkarni R, Ettingshausen C, et al. Population pharmacokinetic modeling of on-demand and surgical use of nonacog beta pegol (N9-GP) and rFIXFc based upon the paradigm 7 comparative pharmacokinetic study. J Blood Med. 2019;10:391–398.
- 1-Stage APTT-Based Factor Assays. Practical-Haemostasis Web site. https://practical-haemostasis.com/Factor%20Assays/1_stage_aptt_factor_assay.html. Accessed August 3, 2017.