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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

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Mechanism of Action in CHwI Video

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

Step 1 Targeting

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  

Step 2 Activation

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    

Step 3 Clot formation

Clot formation

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

Step 4 Bleed resolution

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

Approved for surgical use and

procedures in 4 indicated disorders.

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serious condition.

Understanding acquired hemophilia

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Visit website | Prescribing Information

Visit website | Prescribing Information

Visit website | Prescribing Information

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. 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.