Acquired hemophilia.

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

Acquired hemophilia.

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

Up to 21% mortality rate.2

Acquired hemophilia strikes without warning and is challenging to diagnose. Delays in diagnosis and treatment put patients with acquired hemophilia at risk.3,4  

tab Efficacy

Control the bleed with NovoSeven® RT.

An international consensus recommends NovoSeven® RT as a first-line treatment for acquired hemophilia.5 

aData were extracted from a review of experiences with rFVIIa for the treatment of acquired hemophilia in compassionate-use programs, the Hemophilia & Thrombosis Research Society (HTRS) registry, the European Acquired Hemophilia (EACH2) registry, and independent published reports. 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.6,7

Efficacy with NovoSeven® RT treatment.6,7,a

aData were extracted from a review of experiences with rFVIIa for the treatment of acquired hemophilia in compassionate-use programs, the Hemophilia & Thrombosis Research Society (HTRS) registry, and independent published reports. 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.6,7

tab Safety Profile

NovoSeven® RT is designed for safety.

NovoSeven® RT works at the site of vascular injury. It’s the only recombinant bypassing agent not made from human serum or human proteins, with 4% of patients with acquired hemophilia experiencing thrombotic events.1  

tab Tailored Dosing

Adjustable dosing.

Based on the severity of bleeding, adjust dose and frequency of injections to each individual patient.

bThe minimum effective dose has not been determined.

Dosing recommendation for acquired hemophilia.1,b

ACQUIRED HEMOPHILIA

70-90 mcg/kg

every 2-3 hours

until hemostasis is achieved


bThe minimum effective dose has not been determined.
 

Compare NovoSeven® RT with Obizur™ for acquired hemophilia.

Based on the initial dose for a 70-kg patient with acute bleeding

NovoSeven® RT1

Obizur™8

Doctor attending to girl in hospital bed

Approved for surgical use and

procedures in patients with

acquired hemophilia.


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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.

Indications and Usage

NovoSeven® RT (Coagulation Factor VIIa [Recombinant]) is a coagulation factor indicated for:

  • Treatment of bleeding episodes and peri-operative 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 peri-operative 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.
  • Exercise caution when administering NovoSeven® RT to patients with an increased risk of thromboembolic complications, such as those with disseminated intravascular coagulation (DIC), advanced atherosclerotic disease, crush injury, septicemia, uncontrolled post-partum hemorrhage, history of coronary heart disease, liver disease, post-operative immobilization, in elderly patients, in neonates, or in patients receiving concomitant treatment with aPCCs/PCCs (activated or nonactivated prothrombin complex concentrates).
  • Hypersensitivity reactions, including anaphylaxis, have been reported with NovoSeven® RT. Administer only if clearly needed in patients with known hypersensitivity to NovoSeven® RT, any of its components, or mouse, hamster, or bovine proteins. Should symptoms occur, discontinue NovoSeven® RT and administer appropriate treatment.
  • 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. NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2017.
  2. Bitting RL, Bent S, Li Y, Kohlwes J. The prognosis and treatment of acquired hemophilia: a systematic review and meta-analysis. Blood Coagul Fibrinolysis. 2009;20(7):517-523.
  3. Collins PW. Therapeutic challenges in acquired factor VIII deficiency. Hematology Am Soc Hematol Educ Program. 2012;2012:369-374.
  4. Collins PW, Chalmers E, Hart D, et al; United Kingdom Haemophilia Centre Doctors’ Organization. Diagnosis and management of acquired coagulation inhibitors: a guideline from UKHCDO. Br J Haematol. 2013;162(6):758-773.
  5. 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.
  6. Baudo F, Collins P, Huth-Kühne A, et al. Management of bleeding in acquired hemophilia A: results from the European Acquired Haemophilia (EACH2) Registry. Blood First Edition paper, May 22, 2012; DOI 10.1182/blood-2012-02-40893.
  7. 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.

  8. Obizur [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; 2014.