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Important Safety Information  |  Prescribing Information
NovoSeven® RT Coagulation Factor VIIa (Recombinant) logo.
Indicated for congenital hemophilia A or B with inhibitors, congenital Factor VII deficiency, Glanzmann’s thrombasthenia with refractoriness to platelets, and acquired hemophilia. See full indication below.
Success Speaks for Itself | Healthcare Professional Series
I’ll never forget my first patient. When his life was in danger, I knew where to turn for fast bleed control.”1
30+ years of fast, trusted bleed control for even the most life-threatening bleeds.2,3,a
NovoSeven® RT is proven effective for bleed resolution and indicated for the broadest range of patients with bleeding disorders, compared to FEIBA®, OBIZUR®, and SEVENFACT®.5-8,b
NovoSeven® RT is the only rFVII approved for surgery across all ages of CHAwI or CHBwI, CFVIId, and GT and adults with AH.5
NovoSeven® RT is the only rFVII that has clinical study experience with Hemlibra for patients with CHAwI.9
 Learn More 
Across indications, in emergent situations, and day-to-day, NovoSeven® RT is there for your patients when they need it most.2,5
aIn compassionate use situations including surgery, central nervous system hemorrhages, severe intra-abdominal bleeding, and other life-threatening bleeding episodes.
bIndicated for bleed control and surgery in 4 bleeding disorders: CHAwI or CHBwI, AH, CFVIId, and GT.5
Scroll to see how NovoSeven® RT continues to support your patients.
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
Please click here or scroll below for additional Important Safety Information.
Effective treatment for a broad rangec of bleeding disorders4,5
Indications NovoSeven® RT5,d FEIBA®6,e OBIZUR®7,f SEVENFACT®8,g,h
Congenital hemophilia A with inhibitors  
Congenital hemophilia B with inhibitors  
Acquired hemophiliai    
Congenital factor VII deficiency      
Glanzmann's thrombasthenia      
with refractoriness to platelet transfusions, with or without antibodies to platelets        
NovoSeven® RT5,d FEIBA®6,e OBIZUR®7,f SEVENFACT®8,g,h
Congenital hemophilia A with inhibitors
 
Congenital hemophilia B with inhibitors
 
Acquired hemophiliai
   
Congenital factor VII deficiency
     
Glanzmann’s thrombasthenia with refractoriness to platelets transfusions, with or without antibodies to platelets
     
 = bleed treatment;    = perioperative management
This chart is not intended to compare efficacy or safety.
 Why NovoSeven® RT 
cAs compared to FEIBA, OBIZUR and SEVENFACT.
dNovoSeven® RT is a recombinant FVIIa.
eFEIBA is an activated prothrombin complex concentrate (aPCC).
fOBIZUR is a porcine sequence recombinant FVIII.
gSEVENFACT is a recombinant FVIIa.
hSEVENFACT is only indicated for adults and adolescents (12 years and older).
iAdults with acquired hemophilia.
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
Stay tuned for more information about NovoSeven® RT, as part of the Success Speaks for Itself Series.
To learn more right away, request a call with your Hemophilia Institutional Account Manager.
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Important Safety Information (cont’d)
Warnings and Precautions
• 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. Data on file as of 2020. Novo Nordisk Inc; Plainsboro, NJ.
2. Hedner U. History of rFVIIa therapy. Thromb Res. 2010;125:S4-S6.
3. Lusher JM, Roberts HR, Davignon G, et al; and rFVIIa Study Group. A randomized, double-blind comparison of two dosage levels of recombinant factor VIIa in the treatment of joint, muscle and mucocutaneous haemorrhages in persons with haemophilia A and B, with and without inhibitors. Haemophilia. 1998;4(6):790-798.
4. Bysted BV, Scharling B, Moller T, Hansen BL. A randomized, double-blind trial demonstrating bioequivalence of the current recombinant activated factor VII formulation and a new robust 25°C stable formulation. Haemophilia. 2007;13(5): 527-532.
5. NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2020.
6. FEIBA [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; 2020.
7. OBIZUR [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; 2020.
8. SEVENFACT [package insert]. Louisville, KY: HEMA Biologics; 2020.
9. Levy GG, Asikanius E, Kuebler P, et al. Safety analysis of rFVIIa with emicizumab dosing in congenital hemophilia A with inhibitors: experience from the HAVEN clinical program. J Thromb Haemost. 2019;17(9):1470-1477
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