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Medical Information | Non-US Health Care Professionals
Important Safety Information | Patient Site
Prescribing Information
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
What NovoSeven® RT means to your patients

What NovoSeven® RT means to your patients

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The experience continues

30+ years of research and long-term clinical experience; 1,106 patients and 5,305 bleeds treated in registrational studies and ~400 successful surgeries and procedures.1-25,a-c

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Clinical experience with Hemlibra®

NovoSeven® RT is the only rFVIIa proven safe to use with Hemlibra for patients with hemophilia A with inhibitors.26

Bleed control icon

Effective control of the mildest to most life-threatening bleeds

Proven effective for bleed resolution and surgery across 4 indications.1

  • NovoSeven® RT is the only rFVIIa indicated for CHwI patients of all ages1
Mixing icon

#1 prescribed rFVIIa in hospitals27

NovoSeven® RT is the only rFVIIa approved for surgery and for use in patients of all ages.1

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Able to quickly treat bleeds when they occur

Rapid administration and infusion, leading to rapid activity.1,28

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Portability to fit into your patients’ lives

Room temperature stable for rapid access to treatment. Everything patients need to reconstitute is in one small box.1,d

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A well-established safety profile

A low rate of thrombotic events based on clinical trials and registries.1,e

  • 0.2% of bleeding episodes in patients with CHwI 
  • 4% in patients with AH 
  • <0.2% in patients with GT
  • 0.8% in patients with CFVIId29,f

And NovoSeven® RT is not made from human serum or human proteins.1,30

a1988: compassionate use initiated in the United States; 1999: FDA approval received for CHwI.30
bIncludes bleeding episodes, major and minor surgical procedures, traumatic injuries, and prophylaxis regimens.
cSuccess was defined differently in each study.
dPrior to reconstitution, store NovoSeven® RT powder and histidine diluent between 36-77˚F. After reconstitution, store NovoSeven® RT either at room temperature or refrigerated for up to 3 hours. Do not freeze reconstituted NovoSeven® RT or store in syringes.
eIn clinical trials and registries used to support licensure and in postmarketing surveillance, the overall rate of thrombosis was 0.17% of 12,288 bleeding and surgical episodes.29
fData based on postmarketing retrospective safety assessment of clinical trials and registries.

Learn more about how NovoSeven® RT helps your patients with:

Congenital Hemophilia A or B With Inhibitors

Acquired Hemophilia
 

Congenital Factor VII Deficiency
 

Glanzmann’s Thrombasthenia
 

MixPro® to reconstitute NovoSeven® RT

Patients can use MixPro® to reconstitute NovoSeven® RT.

NovoSeven® RT mechanism of action

NovoSeven® RT mechanism of action.

Rare bleeding disorders patient education

Help your patients learn about rare bleeding disorders.

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. Data on file as of 2010. Novo Nordisk Inc; Plainsboro, NJ.
  3. Shapiro AD, Neufeld EJ, Blanchette VS, et al. Safety of recombinant activated factor VII (rFVIIa) in patients with congenital hemophilia with inhibitors: overall dose exposure and intervals following >240-mcg/kg doses across trial, registry, and diary studies. Poster presented at: 53rd Annual Meeting and Exposition of the American Society of Hematology; December 10-13, 2011; San Diego, California.
  4. Shapiro AD, Gilchrist GS, Hoots WK, et al. Prospective, randomised trial of two doses of rFVIIa (NovoSeven®) in haemophilia patients with inhibitors undergoing surgery. Thromb Haemost. 1998;80(5):773-778. 
  5. Parameswaran R, Shapiro AD, Gill JC, et al. Dose effect and efficacy of rFVIIa in the treatment of haemophilia patients with inhibitors: analysis from the Hemophilia and Thrombosis Research Society Registry. Haemophilia. 2005;11:100-106. 
  6. Ingerslev J, Friedman D, Gastineau D, et al. Major surgery in haemophilic patients with inhibitors using recombinant factor VIIa. Haemostasis. 1996;26:118-123. 
  7. Rodriguez-Merchan EC, Wiedel JD, Wallny T, et al. Elective orthopedic surgery for hemophilia patients with inhibitors: new opportunities. Semin Hematol. 2004;41(1):109-116.
  8. Giangrande PLF, Wilde JT, Madan B, et al. Consensus protocol for the use of recombinant activated factor VII [eptacog alfa (activated): NovoSeven®] in elective orthopaedic surgery in haemophilic patients with inhibitors. Haemophilia. 2009;15:501-508. 
  9. Takedani H, Kawahara H, Kajiwara M. Major orthopaedic surgeries for haemophilia with inhibitors using rFVIIa. Haemophilia. 2010;16:290-295. 
  10. Boadas A, Fernandez-Palazzi F, De Bosch NB, et al. Elective surgery in patients with congenital coagulopathies and inhibitors: experience of the National Haemophilia Centre of Venezuela. Haemophilia. 2011;17:422-427. 
  11. Polyanskaya T, Zorenko V, Karpow E, et al. Experience of recombinant activated factor VII usage during surgery in patients with haemophilia with inhibitors. Haemophilia. 2012;18:997-1002. 
  12. Takedani H, Shima M, Horikoshi Y, et al. Ten-year experience of recombinant activated factor VII use in surgical patients with congenital haemophilia with inhibitors or acquired haemophilia in Japan. Haemophilia. 2015;21:374-379. 
  13. Balkan C, Karapinar D, Aydogdu S, et al. Surgery in patients with haemophilia and high responding inhibitors: Izmir experience. Haemophilia. 2010;16:902-909. 
  14. Salaj P, Gurlich R, Svorcova V, et al. Prophylactic preparation and surgical extirpation of a very large abdominal blood cyst in a severe haemophilia A patient with inhibitors managed by rFVIIa. Haemophilia. 2009;15:380-382. 
  15. Valentino LA, Cooper DL, Goldstein B. Surgical Experience with rFVIIa (NovoSeven®) in congenital haemophilia A and B patients with inhibitors to factors VIII or IX. Haemophilia. 2011;17:579-589. 
  16. Rodriguez-Merchan EC, Jimenez-Yuste V, Gomez-Cardero P, et al. Surgery in haemophilia patients with inhibitors, with special emphasis on orthopaedics: Madrid experience. Haemophilia. 2010;16:84-88. 
  17. Caviglia H, Candela M, Galatro G, et al. Elective orthopaedic surgery for haemophilia patients with inhibitors: single centre experience of 40 procedures and review of the literature. Haemophilia. 2011;17:910-919.
  18. Banov L, Pavanello M, Piattelli G, et al. Successful urgent neurosurgery management with rFVIIa mega doses in a child with haemophilia A and high titre inhibitor. Blood Coagul Fibrinolysis. 2014;25:518-521. 
  19. de Souza DG, Waldron PE, Peeler BB, et al. The use of activated factor VII for ventricular septal defect closure in a pediatric patient with hemophilia A and a high titer of inhibitor. J Cardiothorac Vasc Anaesth. 2009;23(5):679-681. 
  20. Aouba A, Dezamis E, Sermet A, et al. Uncomplicated neurosurgical resection of a malignant glioneuronal tumour under haemostatic cover of rFVIIa in a severe haemophilia patient with a high-titre inhibitor: a case report and literature review of rFVIIa use in major surgeries. Haemophilia. 2010;16:54-60. 
  21. Goudemand J, Tagariello G, Lopaciuk F. Cases of surgery in highresponder haemophilia patients. Haemophilia. 2004;10(2):46-49. 
  22. Watts, RG. Successful use of recombinant factor VIIa for emergency fasciotomy in a patient with hemophilia A and high-titer inhibitor unresponsive to factor VIII inhibitor bypassing activity. Am J Haematol. 2005;79:58-60. 
  23. Rajic N, Savic A, Popovic S, et al. Successful control of bleeding during supracondylar amputation caused by severe compartment syndrome in patient with haemophilia A and high titre of inhibitor. Haemophilia. 2009;15:601-602. 
  24. Mehta S, Nelson CL, Konkle BA, et al. Total knee arthroplasty using recombinant factor VII in hemophilia-A patients with inhibitors. J Bone Joint Surg Am. 2004;86-A(2):2519-2521. 
  25. Pruthi RK, Mathew P, Valentino LA, et al. Haemostatic efficacy and safety of bolus and continuous infusion of recombinant factor VIIa are comparable in haemophilia patients with inhibitors undergoing major surgery. Thromb Haemost. 2007;98(4):726-732.
  26. 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.
  27. Data on file as of 2019. Novo Nordisk Inc; Plainsboro, NJ.
  28. Bysted BV, Scharling B, Moller T, Hansen BL. A randomized, double-blind trial demonstrating bioequivalence of the current recombinant activated factor VII formulation and a new robust 25°C stable formulation. Haemophilia. 2007;13(5):527-532.
  29. Rajpurkar M, Croteau SE, Boggio L, et al. Thrombotic events with recombinant activated factor VII (rFVIIa) in approved indications are rare and associated with older age, cardiovascular disease, and concomitant use of activated prothrombin complex concentrates (aPCC). Journal of Blood Medicine. 2019;10:335-340.
  30. Hedner U. History of rFVIIa therapy. Thromb Res. 2010;125:S4-S6.