NOVOMEDLINK™
  1. Activella®

    (estradiol/norethindrone acetate tablets)

  2. Vagifem®

    (estradiol vaginal tablets)

  3. GlucaGen® HypoKit®

    (glucagon [rDNA Origin] for injection)

  4. Levemir®

    (insulin detemir [rDNA origin] injection)

  5. Norditropin®

    (somatropin (rDNA origin) injection)

  6. NovoLog®

    (Insulin aspart [rDNA origin] injection)

  7. NovoLog® Mix 70/30

    (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin])

  8. NovoSeven® RT

    Coagulation Factor VIIa (Recombinant) Room
    Temperature Stable

  9. NovoSeven®

    (Coagulation Factor VIIa [Recombinant])

About NovoSeven® RT

NovoSeven® RT is the only recombinant Factor VIIa available. It provides rapid, effective, and safe treatment for:

  • Congenital hemophilia A or B with inhibitors
  • Acquired hemophilia
  • Congenital Factor VII deficiency
  • Bleeding during and after surgery in the above conditions

NovoSeven® (Coagulation Factor VIIa [Recombinant]) is now NovoSeven® RT

  • Provides rapid efficacy61
    • Resolves most joint bleeds in as few as 5 hours
    • 91% effective at resolving joint bleeds
  • Provides same safety profile
    • Low risk of thrombosis85
    • Only recombinant bypassing agent
  • Allows for faster initiation and administration of treatment85
    • Room temperature formulation—can be stored outside of the refrigerator
    • 40% less infusion volume85,79

How NovoSeven® RT Works

NovoSeven® RT targets the site of injury by binding to activated platelets and tissue factor.

  • mechanism of action 01

    NovoSeven® RT enters the bloodstream and targets the site of injury. It can support thrombin generation for FVIII or FIX deficiency64

  • mechanism of action 02

    NovoSeven® RT binds directly to activated platelets, activating Factor X to produce Factor Xa85,64

    Factor Xa leads to the conversion of prothrombin to thrombin85

  • mechanism of action 03

    The burst of thrombin may cause the formation of fibrin, which is the foundation of a stable clot85

  • mechanism of action 04

    NovoSeven® RT resolves the bleed by allowing the formation of a stable hemostatic plug85

View an animated demonstration of the mechanism of action of NovoSeven® RT.

History of NovoSeven® RT
1985 NovoSeven project at Novo Nordisk
1988 First patient with an inhibitor was successfully treated with rFVIIa
1988 Compassionate Use Program began
1989 Clinical Development Program—Phase I/II
Dose-escalation studies evaluating efficacy, safety, and PK in bleeding and nonbleeding patients with and without inhibitors. Additional randomized, double-blind study and home treatment study
1996 EU approval
1999 US approval (hemophilia A or B with inhibitors)
2005 US approval (surgery in people with hemophilia A or B with inhibitors and bleeding episodes/surgery in congenital Factor VII deficiency)
2006 Dedication of Novo Nordisk Research US
The first research center in the US dedicated to investigating therapies to prevent or stop critical bleeding
2006 US approval (bleeding episodes/surgery in people with acquired hemophilia)
2008 NovoSeven® RT introduced

In the 1980s, a team of Novo Nordisk scientists led by Dr. Ulla Hedner developed a genetically engineered form of Factor VII protein, recombinant Factor VIIa (rFVIIa). This particular protein was created to treat hemophilia patients who had developed inhibitors that prevented traditional treatments with FVIII and FIX from working. When NovoSeven® was launched in Europe in 1996, it signified a major advancement in the treatment of this small group of hemophilia patients for whom there were limited options. NovoSeven® was approved for use in the US in 1999.

  1. NovoSeven® RT Coagulation Factor VIIa (Recombinant) Room Temperature Stable Indications and Usage

    NovoSeven® RT is indicated for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to FVIII or FIX and in patients with acquired hemophilia; prevention of bleeding in surgical interventions or invasive procedures in hemophilia A or B patients with inhibitors to FVIII or FIX and in patients with acquired hemophilia; treatment of bleeding episodes in patients with congenital Factor VII deficiency and prevention of bleeding in surgical interventions or invasive procedures in patients with congenital FVII deficiency.

    NovoSeven® RT Important Safety Information

    • Most common adverse events: pyrexia, hemorrhage, injection site reaction, arthralgia, headache, hypertension, hypotension, nausea, vomiting, pain, edema, and rash.
    • Patients with disseminated intravascular coagulation (DIC), advanced atherosclerotic disease, crush injury, septicemia, or concomitant treatment with activated or nonactivated prothrombin complex concentrates (aPCCs/PCCs) may have a potential risk of developing thrombotic events in association with NovoSeven® treatment.
    • Use with caution in patients with known hypersensitivity to NovoSeven®, its components, or mouse, hamster, or bovine proteins.
    • Serious adverse events that may or may not have been related to the use of NovoSeven® in acquired hemophilia (10 of 139 patients in the compassionate use program, HTRS registry, and the published literature) included thrombotic serious adverse events and death.
    • Serious adverse events that may or may not have been related to the use of NovoSeven® occurred in 14 of 298 patients with hemophilia A or B with inhibitors in the initial clinical program.
    • Development of antibodies against FVII has been reported in FVII-deficient patients after treatment with NovoSeven®. These patients had previously been treated with human plasma and/or plasma-derived FVII.
    • Concomitant use of NovoSeven® RT with other formulations of NovoSeven® is not recommended due to potential dosing errors based on different concentrations.
    • The effect of prolonged post-hemostatic dosing of NovoSeven® RT has not been extensively studied in a clinical setting.

    Please see Prescribing Information.

  2. NovoSeven® Coagulation Factor VIIa (Recombinant) Indications and Usage

    For the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to FVIII or FIX and in patients with acquired hemophilia; prevention of bleeding in surgical interventions or invasive procedures in hemophilia A or B patients with inhibitors to FVIII or FIX and in patients with acquired hemophilia; treatment of bleeding episodes in patients with congenital Factor VII deficiency and prevention of bleeding in surgical interventions or invasive procedures in patients with congenital FVII deficiency.

    (Acquired only) For the treatment of bleeding episodes in patients with acquired hemophilia. For the prevention of bleeding in surgical interventions or invasive procedures in patients with acquired hemophilia.

    NovoSeven® Important Safety Information

    • Most common adverse events: pyrexia, hemorrhage, injection site reaction, arthralgia, headache, hypertension, hypotension, nausea, vomiting, pain, edema, and rash.
    • Patients with disseminated intravascular coagulation (DIC), advanced atherosclerotic disease, crush injury, septicemia, or concomitant treatment with activated or nonactivated prothrombin complex concentrates (aPCCs/PCCs) may have a potential risk of developing thrombotic events in association with NovoSeven treatment.
    • Contraindicated in patients with known hypersensitivity to NovoSeven, its components, or mouse, hamster, or bovine proteins.
    • Serious adverse events that may or may not have been related to the use of NovoSeven in acquired hemophilia (10 of 139 patients in the compassionate use program, HTRS registry, and the published literature) may include thrombotic serious adverse events and death.
    • Serious adverse events that may or may not have been related to the use of NovoSeven occurred in 14 of 298 patients with hemophilia A or B with inhibitors in the initial clinical program.
    • Development of antibodies against FVII has been reported in FVII deficient patients after treatment with NovoSeven. These patients had previously been treated with human plasma and/or plasma-derived FVII.

    Please see Prescribing Information.

Levemir®, NovoLog®, NovoLog® Mix 70/30, GlucaGen®, and HypoKit® are registered trademarks of Novo Nordisk A/S. NovoSeven® RT and Norditropin® are registered trademark and SevenSECURE™ is a trademark of Novo Nordisk Health Care AG. Activella® 1.0 mg/0.5 mg and Activella® 0.5 mg/0.1 mg and Vagifem® are registered trademarks of Novo Nordisk FemCare AG.