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Works at the site of injury.1

NovoSeven® RT is recombinant Factor VIIa. It can support thrombin generation for patients with congenital hemophilia A or B with inhibitors.1,2

NovoSeven® RT (Coagulation Factor VIIa [Recombinant]) Mechanism of Action video
Mechanism of Action in CHwI Video

See NovoSeven® RT for congenital hemophilia with inhibitors in action.

Mechanism of Action in CHwI Video

See NovoSeven® RT for congenital hemophilia with inhibitors in action.

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NovoSeven® RT resolves bleeds in CHwI by allowing the formation of a stable hemostatic plug.

Targeting illustration

Targeting

NovoSeven® RT enters the bloodstream and targets the site of injury. It can support thrombin generation for patients with congenital hemophilia (FVIII or FIX deficiency) who have inhibitors to replacement factor.1,2  

Activation illustration

Activation

NovoSeven® RT binds directly to activated platelets, activating FX to produce FXa.1,2 FXa complexes with other factors to convert prothrombin to thrombin.1    

Clot formation illustration

Clot formation

The burst of thrombin leads to the formation of fibrin, which is the foundation of a stable clot.1  

Bleed resolution illustration

Bleed resolution

NovoSeven® RT resolves the bleed by allowing the formation of a stable hemostatic plug.1  

The only recombinant bypassing agent not made from human serum or human proteins.1

NovoSeven® RT is manufactured in cell lines considered to be free of viruses, and undergoes additional steps to help ensure safety and purity. Recombinant factor products minimize the possibility of viral contamination.1,3  

Learn More About Recombinant Safety

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Approved for bleed management and

surgical use in 4 indicated disorders.

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serious condition.

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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

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 including boxed Warning.

References:

  1. NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2019.
  2. Hoffman M, Monroe DM III. A cell-based model of hemostasis. Thromb Haemost. 2001; 85(6):958-965.
  3. National Hemophilia Foundation. MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders, #250. New York, NY: National Hemophilia Foundation; 2017.