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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.
Success Speaks for Itself | Hospital Series
Make Sure You're Prepared for Breakthrough Bleeds in Hemlibra® Patients
Success Speaks for Itself | Pharmacy Series
Prepare Your Pharmacy to Treat Breakthrough Bleeds in Hemlibra® Patients
Even if a CHAwI patient treats with Hemlibra, MASAC recommends that breakthrough bleeds be treated immediately with an rFVIIa such as NovoSeven® RT.1
• rFVIIa should be the 1st option
• Emicizumab alone should not be presumed as adequate for major procedures
• Use of pd-aPCC should be avoided if possible
• rFVIIa should be provided to patients pre- and post-operatively at the discretion of the treating physician
• rFVIIa should be the 1st option
• Use of pd-aPCC should be avoided if possible
• Emicizumab alone should not be presumed as adequate for major procedures
• rFVIIa should be provided to patients pre- and post-operatively at the discretion of the treating physician
 See NovoSeven® RT Dosing Info 
Keep scrolling to learn more about an effective rFVIIa treatment.
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.
Why Your Patients Should Have NovoSeven® RT on Hand
NovoSeven® RT is the only rFVIIa that has published clinical study experience with Hemlibra® for patients with CHAwI. The safety of using NovoSeven® RT in conjunction with Hemlibra was analyzed in the HAVEN clinical trials program:2,a
61

CHAwI patients studied in HAVEN 1, 2, and 4

180

Bleeds treated with
NovoSeven® RT only in HAVEN 1

0

SAEs, TMAs, or TEs with NovoSeven® RT alone in HAVEN 1, 2, and 4

SAE=serious adverse event; TMA=thrombotic microangiopathy; TE=thrombotic event
aThe 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.
 Take a Closer Look 
Stay tuned for more information about NovoSeven® RT, as part of the Success Speaks for Itself Series.
To learn more right away, schedule a call with your Hemophilia Institutional Account Manager.
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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. National Hemophilia Foundation. Recommendation on the use and management of emicizumab-kxwh (Hemlibra®) for hemophilia A with and without inhibitors. MASAC Document #268. https://www.hemophilia.org/sites/default/files/document/files/268_Emicizumab.pdf
2. 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.
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