Novo Nordisk

Clinical data across multiple care settings, including surgery.

NovoSeven^® RT (coagulation Factor VIIa, recombinant) is indicated for: Treatment of bleeding episodes and perioperative management in adults and children with congenital hemophilia A or B with inhibitors, congenital Factor VII deficiency, Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, and treatment of bleeding episodes and perioperative management in adults with acquired hemophilia.

NovoSeven^® RT is the only bypassing agent FDA-approved for acquired hemophilia,^1,2 a spontaneous, rare, and potentially fatal disease³

Model is used for illustrative purposes only.

Effectively control bleeds in acquired hemophilia

First-line
treatment^4,a

Salvage
therapy^4,a

Effectiveness in surgeries/procedures^1,4,a

^aData were extracted from a review of experiences with rFVIIa for the treatment for acquired hemophilia in compassionate-use programs, the Hemophilia and Thrombosis Research Society registry, and independently published reports. The percentage of effectiveness noted includes episodes that were evaluated as effective or partially effective. “Ineffective” treatment was determined by the inability to stop the bleeding episode or by the physician describing treatment as not effective. This pertains to 103 bleeding episodes (first-line treatment) and 73 bleeding episodes (salvage therapy) in 139 patients for which efficacy data were available. Bleed protection during surgery data related to 57 surgical bleeding episodes.⁴

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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.

Established safety profile

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

See Important Safety Information, including Boxed Warning.

Data from clinical trials¹

Occurrence of thrombotic events

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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.
2.	OBIZUR [package insert]. Westlake Village, CA: Baxalta US Inc; 2024.
3.	Radinsky LW, Sivan M, Lubetsky A et al. Acquired hemophilia - a case series and review. J Clin Med. 2025;14(5): 1597.
4.	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.

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