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Important Safety Information  |  Prescribing Information
NovoSeven® RT Coagulation Factor VIIa (recombinant)
NovoSeven® RT is indicated for congenital hemophilia A or B with inhibitors, congenital Factor VII deficiency, Glanzmann’s thrombasthenia with refractoriness to platelets, and acquired hemophilia.
1988 1998 2008 2018 2020
30+ years of experience
and counting.
For 30+ years, NovoSeven® RT has offered proven bleed control that professionals have come to trust.1,a NovoSeven® RT helps the broadest range of patients with bleeding disorders as compared to FEIBA® and Obizur®.2-4 Indicated for bleed control and surgery in 4 bleeding disorders: CHAwI or CHBwI, AH, CFVIId, and GT.1
 See the Clinical Data 
Scroll to see how NovoSeven® RT continues to support your patients.
a1988: compassionate use initiated in the United States and included patients with hemophilia A or B (with or without inhibitors), persons with acquired inhibitors to factor VIII or factor IX, and FVII deficient patients; 1999: FDA approval received for CHwI.1,2 2014: FDA approval received for GT.5
1988 1998 2008 2018 2021
30+ years of experience
and counting.
For 30+ years, NovoSeven® RT has offered proven bleed control that professionals have come to trust.1,a NovoSeven® RT helps the broadest range of patients with bleeding disorders as compared to FEIBA® and Obizur®.2-4 Indicated for bleed control and surgery in 4 bleeding disorders: CHAwI or CHBwI, AH, CFVIId, and GT.1
 See the Clinical Data 
Scroll to see how NovoSeven® RT continues to support your patients.
a1988: compassionate use initiated in the United States and included patients with hemophilia A or B (with or without inhibitors), persons with acquired inhibitors to factor VIII or factor IX, and FVII deficient patients; 1999: FDA approval received for CHwI.1,2 2014: FDA approval received for GT.5
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.
The reliability of NovoSeven® RT continues.
As new treatments emerge for CHAwI patients, NovoSeven® RT continues to be a reliable backup therapy. Recombinent FVIIa is a necessary bypassing agent for patients taking Hemlibra®, and NovoSeven® RT manages acute bleeds without increasing risk of thrombosis and TMAs.6,7,b
 Explore the Safety Analysis 
CHAwI=congenital hemophilia A with inhibitors; TMA=thrombotic microangiopathy
bThe analysis included bleeding episodes in the HAVEN 1, HAVEN 2, and HAVEN 4 clinical trials for which patients with CHAwI on emicizumab prophylaxis (at the labeled dose) used rFVIIa. Initial individual dosing with rFVIIa, dosing intervals, and cumulative dosing were evaluated. All adverse events reported in each of the 3 trials, including available narratives, were assessed.6
'I like that NovoSeven<sup>®</sup> RT has a fast infusion time compared to my previous product.' -Miguel, who has hemophilia B with inhibitors
Share these stories with your patients.
Patients can learn from and find inspiration in the stories of those living with rare bleeding disorders. Hear from Miguel and others to see why they choose NovoSeven® RT.
 Watch Patient Stories 
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 (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.
References:
  1. Hedner U. History of rFVIIa therapy. Thromb Res. 2010;125:S4-S6.
  2. NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2020.
  3. FEIBA [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; 2020.
  4. Obizur [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; 2020.
  5. Solh T, Botsford A, Solh M. Glanzmann’s thrombasthenia: pathogenesis, diagnosis, and current and emerging treatment options. Journal of Blood Medicine. 2015;6:219-227.
  6. 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.
  7. National Hemophilia Foundation. MASAC recommendations on the use and management of emicizumab-kxwh (Hemlibra®) for hemophilia A with and without inhibitors, #258. New York, NY: National Hemophilia Foundation; 2020.
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