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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.
Be ready for bleeds across all ages
NovoSeven® RT provides effective control of the mildest to most life-threatening bleeds.1 And it’s the only rFVIIa indicated for use with CHwI patients under age 12.1,2
Illustration of blood droplets under a circle graph showing NovoSeven® RT was 93% effective in a clinical trial of CHwI patients.
One of the largest clinical trials conducted in CHwI patients3
Illustration of people under a circle graph showing NovoSeven® RT was 94% effective in a clinical trial of children with CH and CHwI.
Trial included 20 children ages < 12 and 8 children ages 12 to 161
 See CHwI Trial Data 
CHwI = congenital hemophilia with inhibitors
CH = congenital hemophilia
rFVIIa = recombinant factor VIIa
aData from an international, multicenter, randomized, double-blind, active controlled, confirmatory phase 3 trial of patients with hemophilia A or B with inhibitors (n=69). Primarily carried out in the home setting, all bleeds were treated, and each bleeding episode was randomized (3:2) to infuse either 1 to 3 doses of vatreptacog alfa (340 bleeding episodes, 80 mcg/kg) or 1 to 3 doses of NovoSeven® RT (227 bleeding episodes; 90 mcg/kg) when bleed symptoms were recognized, preferably within 2 hours of onset. Primary efficacy endpoint indicated effective bleed control defined as no additional hemostatic medication (other than the original medication) given within 12 hours after the initial dose.3
bData from a randomized trial of two doses of NovoSeven (35 or 70 mcg/kg) in treatment of joint, muscle and mucocutaneous bleeds in hemophilia A/B patients with and without inhibitors. Treatment was effective in 94% of patients, defined as definite relief of pain/tenderness as reported by the patient and/or a measurable decrease of the size of the hemorrhage and/or arrest of bleeding within 8 hours (rated as excellent = 51%), within 8-14 hours (rated as effective = 18%) or after 14 hours (rated as partially effective = 25%).
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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
Please click here or scroll below for additional Important Safety Information.
Choose the factor with the broadest range of indications.
NovoSeven® RT is the only rFVIIa with four indications, proven to meet the needs of more patients:1,2
  Checkmark showing that NovoSeven® RT is indicated for this condition. Congenital hemophilia A or B with inhibitors  
  Checkmark showing that NovoSeven® RT is indicated for this condition. Acquired hemophilia  
  Checkmark showing that NovoSeven® RT is indicated for this condition. Congenital factor VII deficiency  
  Checkmark showing that NovoSeven® RT is indicated for this condition. Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets  
See what experts have to say about treating bleeds in these indications.
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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. SEVENFACT [package insert]. Louisville, KY: HEMA Biologics, LLC; 2020.
3. Lentz SR, Ehrenforth S, Abdul Karim F, et al; adept™2 investigators. Recombinant factor VIIa analog in the management of hemophilia with inhibitors: results from a multicenter, randomized, controlled trial of vatreptacog alfa. J Thromb Haemost. 2014;12(8):1244-1253.
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