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Important Safety Information  |  Prescribing Information
NovoSeven RT antihemophilic factor (recombinant), glycopegylated-exei logo.
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.
Icon illustration of a checkmark stamped next to a drop of blood.
Make it a first choice for breakthrough bleeds.
Breakthrough bleeds are still possible for CHAwI patients taking Hemlibra®.1
Over 95% of Hemlibra® patients have NovoSeven® RT on hand to treat these bleeds.2 And NovoSeven® RT is the only rFVIIa used concomitantly with Hemlibra® in clinical studies.3,a
 View Safety Data 
CHAwI = congenital hemophilia A with inhibitors
aThe safety of using NovoSeven® RT in conjunction with Hemlibra® was demonstrated in three separate pivotal trials: HAVEN1, 2, and 4. The post-hoc analysis included bleeding episodes in the HAVEN1, HAVEN2, and HAVEN4 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.3
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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
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Four vials of NovoSeven® RT, in sizes of 1 mg, 2 mg, 5mg and 8 mg.
Reliable dosing regimen, flexible options.
The NovoSeven® RT dosing regimen of 90 mcg/kg applies to all bleeds for all CHwI patients. Patients can choose among four vial sizes, allowing them to mix the right amount with little waste.3
CHwI = congenital hemophilia with inhibitors
 Review Dosing & Administration 
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. National Hemophilia Foundation. Recommendation on the Use and Management of Emicizumab-kxwh (Hemlibra®) for Hemophilia A with and without Inhibitors. MASAC Document #258. New York, NY: National Hemophilia Foundation; 2020.
2. Data on file. Novo Nordisk Inc; Plainsboro, NJ.
3. 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.
4. NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2020.
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