> Safety Profile

Safety profile for your patients.

With a proven low rate of thrombotic events and recombinant manufacturing, your patients can rely on the safety profile of NovoSeven® RT.1,2

A proven low rate of thrombotic adverse events.

  • 0.2% of patients with congenital hemophilia experienced thrombotic adverse events in clinical trials1
  • 4% of patients with acquired hemophilia experienced thrombotic events1  

The only recombinant option for all indicated patients.

  • Undergoes a 5-step purification process1,3 
  • The only bypassing agent not made from human serum or human proteins1 
  • Recombinant manufacturing minimizes the possibility of viral contamination4 

The NovoSeven® RT 5-step production and purification process.

Developed in a baby hamster kidney (BHK) cell line.

STEP 1

The working cell bank

Cells are genetically engineered to express rFVIIa.3   
 

STEP 2

Fermentation

Culture media containing newborn calf serum are used to increase the volume of the culture.3  
 

STEP 3

Purification

Centrifugation and filtration remove host cell proteins along with serum and medium components.3   
 

STEP 4

Formulation and freeze-drying

Formulation and sterile filtering; then it is put in to sterile vials and freeze-dried to make a low-volume powder.3  
 

STEP 5

Final inspection

Detailed quality inspection ensures the manufacturing process observes the highest standards of purity.3  
 

Abbreviated representation of the NovoSeven® RT manufacturing process.

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

See how NovoSeven® RT

for CHwI works.

View MOA video

Doctor attending to girl in hospital bed

Approved for surgical use and

procedures in 4 indicated disorders.

See more about surgical use

Acquired hemophilia patient displaying a bruised shoulder

Learn about a rare and

serious condition.

Understanding acquired hemophilia

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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. Abshire T, Kenet G. Safety update on the use of recombinant factor VIIa and the treatment of congenital and acquired deficiency of factor VIII or IX with inhibitors. Haemophilia. 2008;14(5):898-902.
  2. NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2017.
  3. Data on file, Novo Nordisk Inc; Plainsboro, NJ, 2015.
  4. 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.