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. Not for immune tolerance induction.
Predictive PK data
Mild to moderate bleed—controlled with a single dose of Rebinyn®
Compared with SHL, a single 40 IU/kg dose of Rebinyn® was predicted to provide FIX levels above 40% for an average of 23 hours using PK simulations.1
1 dose of Rebinyn® vs 2 doses of SHL rFIX or pdFIX were required to maintain the same WFH target FIX activity level.1
Severe bleed—controlled with 1 dose of Rebinyn® vs 6 doses of SHL
A single 80 IU/kg dose of Rebinyn® was predicted to provide FIX levels above 50% for an average of 3 days using PK simulations.1
1 dose of Rebinyn® vs 6 doses of SHL rFIX or pdFIX were required to maintain the same WFH target FIX activity level.1
Surgery—an initial dose of Rebinyn® maintained FIX levels vs SHL
A single 80 IU/kg dose of Rebinyn®, followed by two 40 IU/kg doses, was predicted to maintain target FIX levels for a 2-week postoperative period using PK simulations.1
3 doses of Rebinyn® vs 17 doses of SHL rFIX or pdFIX were required to maintain the same WFH target FIX activity level.1
Intracranial hemorrhage—Rebinyn® controlled FIX levels with 5 doses vs 28 for SHL
A single 80 IU/kg dose of Rebinyn®, followed by four 40 IU/kg doses, was predicted to maintain target FIX levels for a 3-week period using PK simulations.1
5 doses of Rebinyn® vs 28 doses of SHL rFIX or pdFIX were required to maintain the same WFH target FIX activity level.1
Severe bleed—controlled with 1 dose of Rebinyn® vs 4 doses of Alprolix®
A single 80 IU/kg dose of Rebinyn® was predicted to provide FIX levels above 50% for an average of ≈5 days using PK simulations.2
1 dose of Rebinyn® vs 4 doses of Alprolix® were required to maintain the same WFH target FIX activity level.2
Major surgery—an initial dose of Rebinyn® maintained FIX levels
Compared with EHL, a single 80 IU/kg dose of Rebinyn®, followed by two 40 IU/kg doses, was predicted to maintain target FIX levels for a 2-week postoperative period using PK simulations.2,a
aIn paradigm 7 (vs Alprolix®), an additional sensitivity analysis based on the Prescribing Information which notes Rebinyn® 40 IU/kg may be administered in 1-3 day intervals within the first week of major surgery, additional Rebinyn® 40 IU/kg doses were modeled on days 3, 6 and 13 (4 total doses).
3 doses of Rebinyn® vs 9 doses of Alprolix® were required to maintain the same WFH target FIX activity level.2
Life-threatening bleed—controlled with fewer doses of Rebinyn®
Compared with EHL, a single 80 IU/kg dose of Rebinyn®, followed by four 40 IU/kg doses, was predicted to maintain target FIX levels for a 3-week period using PK simulations.2
5 doses of Rebinyn® vs 11 doses of Alprolix® were required to maintain the same WFH target FIX activity level.2
Rebinyn® may reduce the need for additional infusions1,2,a-c
Based on pharmacokinetic (PK) modeling, Rebinyn® required fewer infusions per episode than SHL and EHL FIX products.
Select a bleed type to see an estimated number of doses and amount of FIX per episode1,2,b-d
Estimated number of doses and amount of FIX per episode1,2,b,c
Estimated number of doses and amount of FIX per episode1,2,c
Estimated number of doses and amount of FIX per episode1,2,c
Estimated number of doses and amount of FIX per episode1,2,c,d
Estimated number of doses and amount of FIX per episode1,2,b-d
bA single dose should be sufficient for minor and moderate bleeds. Additional doses of 40 IU/kg can be given.1
cBased on PK modeling to World Federation of Hemophilia (WFH) guidelines. Simulated results based on phase 1 PK studies (paradigm 1 and 7) of Rebinyn® (n=30), recombinant FIX (rFIX) (n=7), and plasma-derived FIX (pdFIX) (n=8), and rFIXFc (n=15).1,2
dIn paradigm 7 (vs Alprolix®), an additional sensitivity analysis based on the Prescribing Information which notes Rebinyn® 40 IU/kg may be administered in 1- to 3-day intervals within the first week of major surgery, additional Rebinyn® 40 IU/kg doses were modeled on days 3, 6, and 13 (4 total doses).3
Simple prophylaxis dosing
Convenient, once-weekly dosing for all patients.
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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.
- 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.
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 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.
- 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.
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.
References:
- Collins PW, Møss J, Knobe K, et al. Population pharmacokinetic modeling for dose setting of nonacog beta pegol (N9-GP), a glycoPEGylated recombinant factor IX. J Thromb Haemost. 2012;10(11):2305-2312.
- 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.
- Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc.