In a clinical trial of adolescents and adults, Rebinyn® was shown to provide protection from a single dose on the day of surgery.1,a

Leopoldo, who lives with hemophilia B, and is sailing
Leopoldo, who lives with hemophilia B, and is sailing

In a clinical trial of adolescents and adults, Rebinyn® was shown to provide protection from a single dose on the day of surgery.1,a

Leopoldo, who lives with hemophilia B, and is sailing
Leopoldo, who lives with hemophilia B, and is sailing

IN ALL MAJOR SURGERIES STUDIED:1,a

pre-operative dose1

intraoperative success rate1

pre-operative dose1

intraoperative success rate1

aResults 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.

FACTOR IX ACTIVITY SUSTAINED UP TO 48 HOURS POSTSURGERY1,2,b

Graph showing that, with Rebinyn®, factor IX activity sustained up to 48 hours post-surgery
Graph showing that, with Rebinyn®, factor IX activity sustained up to 48 hours post-surgery

bIn 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).

cRange shaded represents the normal population FIX activity range of 50% to 150%.

EFFECTIVE BLEED CONTROL

Jason, who lives with hemophilia B, plays with his dad in a garden

Clinical trials show the efficacy of Rebinyn® in controlling bleeds.1

ESTABLISHED SAFETY PROFILE

Yellow test tubes

Clinical trials showed 0 inhibitors and thrombotic events confirmed in previously treated patients.1

EFFECTIVE BLEED CONTROL

Clinical trials show the efficacy of Rebinyn® in controlling bleeds.1

ESTABLISHED SAFETY PROFILE

Clinical trials showed 0 inhibitors and thrombotic events confirmed in previously treated patients.1

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Selected 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.

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.

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References:

  1. Rebinyn [package insert]. Plainsboro, NJ: Novo Nordisk Inc; May 2017.
  2. 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.
  3. 1-Stage APTT-Based Factor Assays. Practical-Haemostasis Web site. http://practical-haemostasis.com/Factor%20Assays/1_stage_aptt_assays.html. Accessed August 3, 2017.