NovoSeven® RT is the only bypassing agent with controlled clinical trials supporting its efficacy during and after surgery in patients with hemophilia A or B with inhibitors.1,2,a,b

Results of a prospective, randomized trial show the effectiveness of NovoSeven® RT:

Percent of patients with adequate hemostasis:2


Adapted from Shapiro et al.2,b  


aData from a prospective, randomized trial comparing 35 mcg/kg with 90 mcg/kg rFVIIa, each given every 2 hours intraoperatively and in the first 48 hours, then every 2 to 6 hours through day 5. Beyond day 5, patients were treated with open-label 90 mcg/kg until discharge of the investigator. A total of 29 patients underwent 11 major and 18 minor procedures. Data shown are from the 90 mcg/kg group.2   
bIn patients with hemophilia A or B with inhibitors. Actual length of postoperative period may vary.
 

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Tab Acquired Hemophilia
Tab Acquired Hemophilia

NovoSeven® RT is proven effective in perioperative management.1

Doctor talking with acquired hemophilia patient
Tab Congenital Factor VII Deficiency
Tab Congenital Factor VII Deficiency

Perioperative success for patients with congenital factor VII deficiency.1

Tab Glanzmann's Thrombasthenia
Tab Glanzmann's Thrombasthenia

NovoSeven® RT is proven effective in perioperative management in Glanzmann's thrombasthenia patients with refractoriness to platelet transfusions, with or without antibodies to platelets.1,c

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Efficacy of treatment regimens in all procedures

99% and 100% efficacy pie charts of treatment regimens in all procedures

Efficacy in patients with refractoriness and/or antibodiesd

99%, 100% and 100% efficacy pie charts in patients with refractoriness and/or antibodies graphic
99%, 100% and 100% efficacy pie charts in patients with refractoriness and/or antibodies graphic

Efficacy of treatment regimens in all procedures

Efficacy in patients with refractoriness and/or antibodiesd

Methodology: Adjudicator-assessed effectiveness of treatment regimens in patients with GT (N=218 in all severe bleeding episodes and all surgical procedures (N=1073) based on review of Glanzmann’s Thrombasthenia Registry (GTR) data unblinded to investigator-coded efficacy. Efficacy was evaluated on a 2-point scale (clinical assessment of success or failure of treatment regimen as a whole, blinded and unblinded to investigator-coded outcome) including 92 patients treated with NovoSeven® RT for 266 bleeding episodes and 77 patients treated for 160 surgical procedures.1

Data collected from the GTR and the Hemophilia & Thrombosis Research Society registry showed that 140 patients with GT received NovoSeven® RT for 518 bleeding episodes, surgeries, or traumatic injuries. In the GTR, 1 patient reported a serious adverse reaction (deep vein thrombosis) and 1 patient experienced 3 adverse reactions (nausea, headache, and dyspnea). In addition, 2 patients experienced fever and 1 patient experienced headache.1

Methodology: Adjudicator-assessed effectiveness of treatment regimens in patients with GT (N=218 in all severe bleeding episodes and all surgical procedures (N=1073) based on review of Glanzmann’s Thrombasthenia Registry (GTR) data unblinded to investigator-coded efficacy. Efficacy was evaluated on a 2-point scale (clinical assessment of success or failure of treatment regimen as a whole, blinded and unblinded to investigator-coded outcome) including 92 patients treated with NovoSeven® RT for 266 bleeding episodes and 77 patients treated for 160 surgical procedures.1

Data collected from the GTR and the Hemophilia & Thrombosis Research Society registry showed that 140 patients with GT received NovoSeven® RT for 518 bleeding episodes, surgeries, or traumatic injuries. In the GTR, 1 patient reported a serious adverse reaction (deep vein thrombosis) and 1 patient experienced 3 adverse reactions (nausea, headache, and dyspnea). In addition, 2 patients experienced fever and 1 patient experienced headache.1

Methodology: Adjudicator-assessed effectiveness of treatment regimens in patients with GT (N=218 in all severe bleeding episodes and all surgical procedures (N=1073) based on review of Glanzmann’s Thrombasthenia Registry (GTR) data unblinded to investigator-coded efficacy. Efficacy was evaluated on a 2-point scale (clinical assessment of success or failure of treatment regimen as a whole, blinded and unblinded to investigator-coded outcome) including 92 patients treated with NovoSeven® RT for 266 bleeding episodes and 77 patients treated for 160 surgical procedures.1

Data collected from the GTR and the Hemophilia & Thrombosis Research Society registry showed that 140 patients with GT received NovoSeven® RT for 518 bleeding episodes, surgeries, or traumatic injuries. In the GTR, 1 patient reported a serious adverse reaction (deep vein thrombosis) and 1 patient experienced 3 adverse reactions (nausea, headache, and dyspnea). In addition, 2 patients experienced fever and 1 patient experienced headache.1


cData from a prospective, observational, multinational registry study of patients with GT.1   
dIncludes 33 patients (70 procedures) with refractoriness and/or platelet-specific antibodies, 11 patients (24 procedures) with platelet-specific antibodies only, and 36 patients (66 procedures) with neither refractoriness nor antibodies, or unknown status.1   
 

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Selected Important Safety Information

WARNING: THROMBOSIS

  • Serious arterial and venous thrombotic events following administration of NovoSeven® RT have been reported.
  • Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive NovoSeven® RT.
  • Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis.

Indications and Usage

NovoSeven® RT (Coagulation Factor VIIa [Recombinant]) is a coagulation factor indicated for:

  • Treatment of bleeding episodes and peri-operative management in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets
  • Treatment of bleeding episodes and peri-operative management in adults with acquired hemophilia

 

Important Safety Information

WARNING: THROMBOSIS

  • Serious arterial and venous thrombotic events following administration of NovoSeven® RT have been reported.
  • Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive NovoSeven® RT.
  • Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis.

Warnings and Precautions

  • Serious arterial and venous thrombotic events have been reported in clinical trials and postmarketing surveillance.
  • Exercise caution when administering NovoSeven® RT to patients with an increased risk of thromboembolic complications, such as those with disseminated intravascular coagulation (DIC), advanced atherosclerotic disease, crush injury, septicemia, uncontrolled post-partum hemorrhage, history of coronary heart disease, liver disease, post-operative immobilization, in elderly patients, in neonates, or in patients receiving concomitant treatment with aPCCs/PCCs (activated or nonactivated prothrombin complex concentrates).
  • Hypersensitivity reactions, including anaphylaxis, have been reported with NovoSeven® RT. Administer only if clearly needed in patients with known hypersensitivity to NovoSeven® RT, any of its components, or mouse, hamster, or bovine proteins. Should symptoms occur, discontinue NovoSeven® RT and administer appropriate treatment.
  • Factor VII deficient patients should be monitored for prothrombin time (PT) and factor VII coagulant activity (FVII:C). If FVII:C fails to reach the expected level, or PT is not corrected, or bleeding is not controlled after treatment with the recommended doses, antibody formation may be suspected and analysis for antibodies should be performed.
  • Laboratory coagulation parameters (PT/INR, aPTT, FVII:C) have shown no direct correlation to achieving hemostasis.

Adverse Reactions

  • The most common and serious adverse reactions in clinical trials are thrombotic events. Thrombotic adverse reactions following the administration of NovoSeven® RT in clinical trials occurred in 4% of patients with acquired hemophilia and 0.2% of bleeding episodes in patients with congenital hemophilia.

Drug Interactions

  • Thrombosis may occur if NovoSeven® RT is administered concomitantly with Coagulation Factor XIII.

Please click here for Prescribing Information.  

 

References:

  1. NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2017.
  2. Shapiro AD, Gilchrist GS, Hoots WK, Cooper HA, Gastineau DA. Prospective, randomised trial of two doses of rFVIIa (NovoSeven) in haemophilia patients with inhibitors undergoing surgery. Thromb Haemost. 1998;80(5):773-778.