Skip to main content

NovoSeven® RT is the only bypassing agent with controlled clinical trials supporting its efficacy during and after surgery in patients with CHwI.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.

MASAC guidelines recommend administering NovoSeven® RT to patients with congenital hemophilia A with inhibitors taking emicizumab who will undergo major procedures.3

Male sitting on hospital bed
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 CFVIId.1

Tab Glanzmann's Thrombasthenia
Tab Glanzmann's Thrombasthenia

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

Lady leaving hospital room

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   
 

Chart icon

Looking for codes for

coagulation disorders?


NovoSeven® RT (Coagulation Factor VIIa [Recombinant]) different vials

Need dosing

information?


Icon of five people standing

Have a question? We’re

here to help.

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

Warnings and Precautions

  • Serious arterial and venous thrombotic events have been reported in clinical trials and postmarketing surveillance
  • Patients with congenital hemophilia receiving concomitant treatment with aPCCs (activated prothrombin complex concentrates), older patients particularly with acquired hemophilia and receiving other hemostatic agents, and patients with a history of cardiac and vascular disease may have an increased risk of developing thrombotic events

Indications and Usage

NovoSeven® RT (coagulation Factor VIIa, recombinant) is a coagulation factor indicated for:

  • Treatment of bleeding episodes and perioperative 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 perioperative 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
  • Patients with congenital hemophilia receiving concomitant treatment with aPCCs (activated prothrombin complex concentrates), older patients particularly with acquired hemophilia and receiving other hemostatic agents, and patients with a history of cardiac and vascular disease may have an increased risk of developing thrombotic events
  • Hypersensitivity reactions, including anaphylaxis, can occur with NovoSeven® RT. Patients with a known hypersensitivity to mouse, hamster, or bovine proteins may be at a higher risk of hypersensitivity reactions. Discontinue infusion and administer appropriate treatment when hypersensitivity reactions occur
  • 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; 2019.
  2. Shapiro AD, Gilchrist GS, Hoots WK, et al. Prospective, randomised trial of two doses of rFVIIa (NovoSeven) in haemophilia patients with inhibitors undergoing surgery. Thromb Haemost. 1998;80(5):773-778.
  3. National Hemophilia Foundation. Recommendation on the use and management of emicizumab-kxwh (hemlibra®) for hemophilia a with and without inhibitors. MASAC Document #255. https://www.hemophilia.org/Researchers-Healthcare-Providers/Medical-and-Scientific-Advisory-Council-MASAC/MASAC-Recommendations. Accessed December 2018.