> > Acquired Hemophilia

Acquired hemophilia.

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

> > Acquired Hemophilia

Acquired hemophilia.

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

Why NovoSeven?

Efficacy

Tailored dosing

Safety profile

Low volume

Perioperative use

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  

Get the Facts

Learn to Spot the Signs

Get the Facts

Learn to Spot the Signs

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, 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

Efficacy with NovoSeven® RT treatment.6,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

tab Tailored Dosing

Flexible 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

Calculate a Dose for Your Patient

See perioperative dosing recommendations


bThe minimum effective dose has not been determined.
 

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  

Serious arterial and venous thrombotic events have been reported in clinical trials and postmarketing surveillance.1

See Important Safety Information.

Learn More About Recombinant Safety

Compare NovoSeven® RT with Obizur® for acquired hemophilia.

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

NovoSeven® RT1

Obizur7

NovoSeven® RT is proven effective in perioperative management.1

Efficacy with NovoSeven® RT during surgery.6,c

87% effective

cData were extracted from a review of experiences with recombinant FVIIa for the treatment of acquired hemophilia in compassionate use programs, the Hemostasis and 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

child patient in hospital talking with healthcare provider

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NovoSeven® RT to treat AH.

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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 including boxed Warning.

References:

  1. NovoSeven RT [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2019.
  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. 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.
  6. 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.
  7. Obizur [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; 2020.