> 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 with inhibitors experienced thrombotic adverse events in clinical trials1
  • 4% of patients with acquired hemophilia experienced thrombotic events1  
  • <0.2% thrombotic events reported in patients with Glanzmann's thrombasthenia1,a

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 

aIn clinical trials and registries used to support licensure and in postmarketing surveillance, the overall rate of thrombosis was 0.19% of 518 bleeds.5

Contains only rFVIIa.1

NovoSeven® RT is the only bypassing agent not made with any other coagulation factors, such as FIX or FIXa.1,6

MASAC recommends patients with congenital hemophilia B with a history of inhibitors and anaphylaxis not be given FIX-containing products unless bleeding is life-threatening.7

MASAC=Medical and Scientific Advisory Council

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

child patient in hospital talking with healthcare provider

Approved for bleed management and

surgical use in 4 indicated disorders.

See the clinical data

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

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. 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; 2019.
  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, #253. New York, NY: National Hemophilia Foundation; 2018.
  5. Rajpurkar M, Croteau SE, Boggio L, et al. Thrombotic events with recombinant activated factor VII (rFVIIa) in approved indications are rare and associated with older age, cardiovascular disease, and concomitant use of activated prothrombin complex concentrates (aPCC). Journal of Blood Medicine. 2019;10:335-340.
  6. Feiba [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; 2018.
  7. National Hemophilia Foundation. Guidelines for emergency department management of individuals with hemophilia and other bleeding disorders, #252. New York, NY: National Hemophilia Foundation; 2017.
  8. Franchini M, Lippi G. Prothrombin complex concentrates: an update. Blood Transfus. 2010;8:(3)149-154.