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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.
Prepare for patients with
rare bleeding disorders.
Do you see patients experiencing nosebleeds or petechiae? These symptoms may indicate rare bleeding disorders like congenital factor VII deficiency (CFVIId) or Glanzmann’s thrombasthenia (GT).1,2 NovoSeven® RT is the only recombinant therapy for CFVIId and GT.1,2
93% effective
for nonsurgical and surgical bleeds in patients with congenital factor VII deficiency3,a
 Treating Bleeds in CFIIVd 
 
94% effective
for bleeding episodes in patients with Glanzmann’s thrombasthenia3,b
 Treating Bleeds in GT 
aData from the published literature, compassionate use trials, and the Hemophilia and Thrombosis Research Society registry (HTRS) for patients with FVII deficiency (N=70) treated with NovoSeven® RT for 124 bleeding episodes, surgeries, or prophylaxis regimens. Dosing ranged from 6 to 98 mcg/kg administered every 2 to 12 hours (except for prophylaxis [doses administered from 2 times per day up to 2 times per week]). Patients were treated with an average of 1 to 10 doses. Treatment was effective if bleeding stopped or the physician rated the treatment as effective.3,4 bAdjudicator-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.3
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.
 
Support for your rare patients.
Although the CFVIId and GT populations are small, you may see patients with these rare conditions.
FVIId AFFECTS (1) 1 in 500,000 people
 
GT AFFECT (3) ~1 in 1,000,000 people
 
To help your patients start or stay on treatment, learn more about product support programs.
 Explore Product Support 
 
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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.
References:
  1. Mariani G, Bernardi F. Factor VII Deficiency. Seminars in Thrombosis and Hemostasis. 2009;35(4):400-406.
  2. Poon M, Di Minno G, d’Orion R, et al. New insights into the treatment of Glanzmann thrombasthenia. Transfusion Medicine Reviews. 2016;(30):92-99.
  3. NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2020.
  4. Mariani G, Napolitano M, Dolce A, et al. Replacement therapy for bleeding episodes in factor VII deficiency. A prospective evaluation. Thromb Haemost. 2013;109:238–247.
  5. Lapecorella M, Mariani G. Factor VII deficiency: defining the clinical picture and optimizing therapeutic options. Haemophilia. 2008;14:1170-1175.
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