An international consensus recommends NovoSeven® RT as a first-line treatment for acquired hemophilia.3,4
NovoSeven® RT offers effectiveness in surgeries and procedures for people experiencing acquired hemophilia.1,5
First-line treatment5
N=139
Salvage therapy5
N=139
NovoSeven® RT offers effectiveness in surgeries and procedures for people experiencing acquired hemophilia.1,5
Perioperative efficacy
N=20
Studies show a low rate of thrombotic events
Serious arterial and venous thrombotic events have been reported in clinical trials and postmarketing surveillance.1 Thrombotic adverse reactions in pivotal clinical trials occurred in 4% of patients with acquired hemophilia.1
Data from clinical trials1
Occurrence of thrombotic events
NovoSeven® RT is manufactured with safety in mind
NovoSeven® RT is made without human serum or human proteins. Recombinant manufacturing minimizes the possibility of viral contamination.1,6
Study design
Sumner, et al
Compassionate use programs, the Hemostasis and Thrombosis Research Society (HTRS) registry, and independent published reports
Patients considered: Patients diagnosed with acquired hemophilia from compassionate and emergency use programs (N=61), the HTRS (N=9) and independent published reports (N=69).
Study design: Data were extracted from a review of experiences with recombinant FVIIa for the treatment of acquired hemophilia in compassionate and emergency use programs, the Hemostasis and Thrombosis Research Society (HTRS) registry, and independent published reports. Efficacy was evaluated similarly but not identically between compassionate use programs, the HTRS registry, and published reports.
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*As a reminder, for US health care professionals only.
Selected Important Safety Information for NovoSeven® RT
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
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
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
- 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 NovoSeven® RT Prescribing Information, including Boxed Warning.
References
- NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2020.
- OBIZUR [package insert]. Westlake Village, CA: Baxalta US Inc; 2021.
- Kruse-Jarres R, Kempton C, Baudo F, et al. Acquired hemophilia A: updated review of evidence and treatment guidance. Am J Hematol. 2017;92:695–705.
- Tiede A, Collins P, Knobeln P, et al. International recommendations on the diagnosis and treatment of acquired hemophilia A. Haematologica. 2020;105:1-44.
- Sumner MJ, Geldziler BD, Pedersen M, Seremetis S. Treatment of acquired haemophilia with recombinant activated FVII: a critical appraisal. Haemophilia. 2007;13(5):451-461.
- National Hemophilia Foundation. MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders, #263. New York, NY: National Hemophilia Foundation; 2020.