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])

Indications

NovoSeven® RT is approved for use in:

Patients with hemophilia A or B with inhibitors to Factor VIII or Factor IX

  • Treatment of bleeding episodes
  • Prevention of bleeding in surgical interventions or invasive procedures

Patients with congenital Factor VII deficiency

  • Treatment of bleeding episodes
  • Prevention of bleeding in surgical interventions or invasive procedures

Patients with acquired hemophilia

  • Treatment of bleeding episodes
  • Prevention of bleeding in surgical interventions or invasive procedures

Surgery in patients with:

  • Hemophilia A or B with inhibitors to Factor VIII or Factor IX
  • Congenital Factor VII deficiency
  • Acquired hemophilia

  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.

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.