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])

Hemophilia A or B With Inhibitors

As many as 20% to 30% of patients with hemophilia develop inhibitors to their factor-replacement therapy at some time in their lives. Inhibitors usually develop in patients with the severe form of the disorder.51

  • About 15% to 35% of all patients with hemophilia A (Factor VIII deficiency)
    develop inhibitors to Factor VIII.51
  • Inhibitors are much less common in hemophilia B (Factor IX deficiency) at less than 5%.51

Patients with hemophilia A or B with inhibitors are diagnosed with inhibitors after a Bethesda Inhibitor Assay confirms antibody resistance to either FVIII or FIX replacement therapy. Based on Bethesda titers, patients are classified in two categories:

  • Low titer—Patients with inhibitor levels below 5 BU are considered low titer or low responding and can most likely be treated with higher doses of factor to neutralize the inhibitor titer and achieve hemostasis.
  • High titer—Patients with levels at 5 BU or higher are considered high titer or high responding and will need an alternative therapy because of how strongly their inhibitors react to factor replacement.

Bypassing agents such as NovoSeven® RT are used to treat bleeding episodes in patients with inhibitors. Bypassing agents work with platelets and other clotting factors (skipping some of the normal steps where Factor VIII and Factor IX are needed) to make a blood clot and stop the bleeding, even when there isn’t enough Factor VIII or Factor IX in the blood.50 Recombinant Factor VIIa (NovoSeven® RT) bypasses Factor VIII and Factor IX in the coagulation process.

Get information about Efficacy in hemophilia A or B with inhibitors.

Get information about Dosing and Administration for NovoSeven® RT for hemophilia A or B with inhibitors.

  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.

GlucaGen®, HypoKit®, Levemir®, and NovoLog® are registered trademarks and NovoMedLink™ is a trademark of Novo Nordisk A/S. Norditropin® and NovoSeven® are registered trademarks and SevenSECURE™ is a trademark of Novo Nordisk Health Care AG. Activella® and Vagifem® are registered trademarks of Novo Nordisk FemCare AG.