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NovoSeven® RT (coagulation Factor VIIa, recombinant) logo
Important Safety Information | Patient Site
Prescribing Information
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NovoSeven® RT (coagulation Factor VIIa, recombinant) logo

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, Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, and in adults with acquired hemophilia.

Prescribing Information
Important Safety Information | Patient Site
Acquired
hemophilia
Acquired
hemophilia

Model is used
for illustrative
purposes only.

Model is used
for illustrative
purposes only.

Acquired
hemophilia

Model is used
for illustrative
purposes only.

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

See efficacy data
See pivotal safety data
See efficacy data
See pivotal safety data

Effectively control bleeds related to acquired hemophilia

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

NovoSeven® RT as first-line treatment

N=139

Salvage therapy5

NovoSeven® RT as salvage therapy

N=139

NovoSeven® RT offers effectiveness in surgeries and procedures for people experiencing acquired hemophilia.1,5

Perioperative efficacy

NovoSeven® RT as a perioperative

N=20

See study design

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

NovoSeven® RT safety data in acquired hemophilia

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

Review recombinant safety info
Study design
Vial icon

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.

HCP and patient with AH

Explore how hospitals use NovoSeven® RT to treat AH.

See more about hospital use
chest bleed and abdomen bleed

Learn more about diagnosing acquired hemophilia.

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NovoSeven® RT vials

Find the dose for your patients.*

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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

  1. NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2020.
  2. OBIZUR [package insert]. Westlake Village, CA: Baxalta US Inc; 2021.
  3. 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.
  4. Tiede A, Collins P, Knobeln P, et al. International recommendations on the diagnosis and treatment of acquired hemophilia A. Haematologica. 2020;105:1-44.
  5. 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.
  6. 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.
Rare Bleeding Disorders
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