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The #1 prescribed bypassing agent used in hospitals.

The #1 prescribed bypassing agent used in hospitals.

The established efficacy of NovoSeven® RT across four indications makes it the most used rFVIIa in hospitals:1,2

The established efficacy of NovoSeven® RT across four indications makes it the most used rFVIIa in hospitals:1,2

93% effective

Congenital hemophilia with inhibitors2,3,a

Congenital hemophilia with inhibitors2,3,a

95% effective

Acquired hemophilia4,b

Acquired hemophilia4,b

93% effective

Congenital Factor VII deficiency2,c

Congenital Factor VII deficiency2,c

94% effective

Glanzmann’s thrombasthenia2,d

Glanzmann’s thrombasthenia2,d


a
Data from an international, multicenter, randomized, double-blind, active controlled, confirmatory phase 3 trial of patients with hemophilia A or B with inhibitors (n=69). Primarily carried out in the home setting, all bleeds were treated, and each bleeding episode was randomized (3:2) to infuse either 1 to 3 doses of vatreptacog alfa (340 bleeding episodes, 80 mcg/kg) or 1 to 3 doses of NovoSeven® RT (227 bleeding episodes; 90 mcg/kg) when bleed symptoms were recognized, preferably within 2 hours of onset. Primary efficacy endpoint indicated effective bleed control defined as no additional hemostatic medication (other than the original medication) given within 12 hours after the initial dose.3
b
Data were extracted from a review of experiences with rFVIIa for the treatment of acquired hemophilia in compassionate-use programs. Efficacy was defined as “effective” and “partially effective” treatment outcomes. “Ineffective” treatment was determined by the inability to stop the bleeding episode or by the physician describing treatment as not effective.4
c
Data from the published literature, compassionate use trials, and the Hemophilia and Thrombosis Research Society registry (HTRS) for patients with FVII deficiency (N=70) treated with NovoSeven® RT for 124 bleeding episodes, surgeries, or prophylaxis regimens. Dosing ranged from 6 to 98 mcg/kg administered every 2 to 12 hours (except for prophylaxis [doses administered from 2 times per day up to 2 times per week]). Patients were treated with an average of 1 to 10 doses. Treatment was effective if bleeding stopped or the physician rated the treatment as effective.2,5
d
Adjudicator-assessed effectiveness of treatment regimens in patients with GT (N=218) in all severe bleeding episodes and all surgical procedures (N=1073) based on review of Glanzmann’s Thrombasthenia Registry (GTR) data unblinded to investigator-coded efficacy. Efficacy was evaluated on a 2-point scale (clinical assessment of success or failure of treatment regimen as a whole, blinded and unblinded to investigator-coded outcome) including 92 patients treated with NovoSeven® RT for 266 bleeding episodes and 77 patients treated for 160 surgical procedures.2

Male sitting on hospital bed

Inhibitors put patients at higher risk of bleeding complications.

Of patients with congenital hemophilia, approximately 1 in 5 patients with hemophilia A and 3 in 100 patients with hemophilia B develop inhibitors.6 Delayed treatment of bleeds may result in cumulative damage.7

Congenital hemophilia:
•    Affects men predominantly8
•    Symptoms include hemarthrosis and muscle bleeds8
•    Patients may develop alloantibodies which target FVIII or FIX infused into the body9

Male sitting on hospital bed
Doctor talking with acquired hemophilia patient

Early diagnosis is crucial for treating acquired hemophilia.

Acquired hemophilia (AH) is a rare and often idiopathic autoimmune condition that can cause severe and even fatal bleeding.10 Delayed diagnosis is common with over 60% of patients getting diagnosis up to a week after onset of bleeding symptoms.

•    Affects men and women
•    Symptoms include subcutaneous, mucosal, and muscle bleeds
•    Autoantibodies target FVIII produced in the body

Clinical pathways for treating congenital hemophilia and AH in the emergency department.

Review examples of common processes for treating patients who arrive at the emergency department with congenital hemophilia or signs of AH.

NovoSevenRT Packaging

NovoSeven® RT is designed for efficiency in pharmacies.

NovoSeven® RT addresses bleeds, whenever they occur.2 Learn more about the features that make this rFVIIa useful for hospitals and pharmacies.

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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

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 Prescribing Information

References:

  1. Data on file as of 2018. Novo Nordisk Inc; Plainsboro, NJ.
  2. NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2019.
  3. Lentz SR, Ehrenforth S, Abdul Karim F, et al; adept™2 investigators. Recombinant factor VIIa analog in the management of hemophilia with inhibitors: results from a multicenter, randomized, controlled trial of vatreptacog alfa. J Thromb Haemost. 2014;12(8):1244-1253.
  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.
  5. Mariani G, Napolitano M, Dolce A, et al. Replacement therapy for bleeding episodes in factor VII deficiency. A prospective evaluation. Thromb Haemost. 2013; 109:238–247.
  6. Centers for Disease Control and Prevention. Hemophilia. https://www.cdc.gov/ncbddd/hemophilia/inhibitors.html. September 6, 2018. Accessed August 2, 2019.
  7. Salek SZ, Benson GM, Elezovic I, et al. The need for speed in in the management of haemophilia patients with inhibitors. Haemophilia. 2011;17(1):95-102.
  8. Srivastava A, Brewer AK, Mauser-Bunschoten EP, et al. Guidelines for the management of hemophilia. Haemophilia. 2013;19(1):e1-e47.
  9. Carcao M, Goudemand J. Inhibitors in Hemophilia. Montréal, Québec, Canada: World Federation of Hemophilia; 2018.
  10. Huth-Kühne A, Baudo F, Collins P, et al. International recommendations on the diagnosis and treatment of patients with acquired hemophilia A. Haematologica. 2009;94(4):566-575.