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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.
Diagnosing and Treating Glanzmann’s Thrombasthenia (GT)
A NovoSeven® RT Educational Series for Healthcare Professionals
NovoSeven® RT:
The only recombinant bypassing agent for patients with GT with refractoriness to platelets1,2
NovoSeven® RT is proven effective for treating GT-related bleeding episodes and for perioperative management in adults and children with refractoriness to platelet infusions, with or without antibodies to platelets.1,a
All bleeding episodes1,a
94% effective

n=92;
266 bleeding events

n=92; 266 bleeding events

All surgical procedures1,a
99% effective

n=77;
160 bleeding events

n=77; 160 bleeding events

aAdjudicator-assessed effectiveness of treatment regimens in patients with GT (N=218) in all severe bleeding episodes and all surgical procedures (N=1073) based on review of Glanzmann's Thrombasthenia Registry (GTR) data unblinded to investigator-coded efficacy. Efficacy was evaluated on a 2-point scale (clinical assessment of success or failure of treatment regimen as a whole, blinded and unblinded to investigator-coded outcome) including 92 patients treated with NovoSeven® RT for 266 bleeding episodes and 77 patients treated for 160 surgical procedures.
 See Efficacy & Safety Data 
Scroll to learn more about diagnosing GT.
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.
 
Glanzmann's thrombasthenia (GT) can be easy to miss
GT shares symptoms with other acquired platelet disorders and von Willebrand disease, which can make it difficult to spot.3,4,c To help make sure your GT patients get the treatment they need without delay, use this diagnostic algorithm to learn more about identifying the signs and choosing a treatment.
 Try Diagnostic Algorithm 
cNovoSeven® RT is not indicated to treat von Willebrand disease.
 
Learn more about a treatment option for GT with platelet refractoriness: NovoSeven® RT.
Watch your inbox for more information about GT resources, diagnosis, and treatment.
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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, including boxed Warning.
References:
1. NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2020.
2. Poon MC, Di Minno G, d'Oiron R, et al. New insights into the treatment of Glanzmann thrombasthenia. Transfus Med Rev. 2016;30(2):92-99.
3. Solh T, Botsford A, Solh M. Glanzmann's thrombasthenia: pathogenesis, diagnosis, and current and emerging treatment options. J Blood Med. 2015;6:219-227.
4. Lambert MP. What to do when you suspect an inherited platelet disorder. Hematology Am Soc Hematol Educ Program. 2011;2011:377-383.
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