NOVOMEDLINK™
  1. Diabetes Care

    GlucaGen® HypoKit®

    (glucagon [rDNA Origin] for injection)

  2. Levemir®

    (insulin detemir [rDNA origin] injection)

  3. NovoLog®

    (Insulin aspart [rDNA origin] injection)

  4. NovoLog® Mix 70/30

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

  5. Victoza®

    (liraglutide [rDNA origin] injection)

  6. Hormone Therapy

    Activella®

    (estradiol/norethindrone acetate tablets)

  7. Vagifem®

    (estradiol vaginal tablets)

  8. Growth Hormone

    Norditropin®

    (somatropin (rDNA origin) injection)

  9. Hemostasis

    NovoSeven®

    (Coagulation Factor VIIa [Recombinant])

  10. NovoSeven® RT

    Coagulation Factor VIIa (Recombinant) Room
    Temperature Stable

Efficacy

NovoSeven® RT Provides Rapid Efficacy

For Hemophilia A or B with Inhibitors

Recombinant Factor VIIa resolves the majority of joint bleeds in as few as 5 hours.61*

Recombinant Factor VIIa resolves joint bleeds quickly

Median time to resolve joint bleed61

Median time to resolve joint bleed graph

Recombinant Factor VIIa resolves bleeds effectively

Effectively resolves joint bleeds61

Effectively resolves muscle bleeds graph

Effectively resolves muscle bleeds61

Effectively resolves joint bleeds graph

Adapted from Lusher et al.61
Data from a randomized, double-blind, parallel-group, multicenter study of patients with hemophilia A or B with and without an inhibitor. Patients were given recombinant Factor VIIa at dosing intervals of 2 to 3 hours. Percentages reflect the number of patients reporting excellent, effective or partially effective results. Response was rated as “excellent” if patient demonstrated definitive relief of pain/tenderness and/or if there was a measurable decrease in the size of the bleed (or arrest of bleeding) in 8 hours or less. An “effective” response was measured by any of these 3 events occurring from 8 to 14 hours; a “partially effective” response ether occurred after 14 hours or indicated detectable relief of pain/tenderness or decrease in bleeding.61

*Median of 2.0 infusions to resolve a joint bleed; infusions given at intervals of 2.5 hours.

For Surgery in Hemophilia A or B with Inhibitors

  • Recombinant Factor VIIa is 96% effective at controlling bleeding during surgery.68
  • Recombinant Factor VIIa is effective in both major and minor surgery.68

Efficacy for 5 days after surgeryc

Major surgery chart
Minor surgery chart

Adapted from Shapiro et al.68
Data from a prospective, randomized, double-blind trial of 2 doses (35mcg/kg or 90 mcg/kg) of recombinant Factor VIIa in patients with hemophilia A or B with inhibitors (N=24) undergoing minor or major surgery. Efficacy defined as follows: intraoperative bleeding: as expected or less than expected; 0-48 hours after wound closure: bleeding stopped or reduced; days 3-5: adequate control of bleeding.

c Charts show data for recommended dose in the Prescribing Information for NovoSeven® RT (90 mcg/kg). See Dosing for more detailed dosing information.

For Congenital Factor VII Deficiency

Recombinant Factor VIIa is 93% effective in stopping nonsurgical and surgical bleeds in people with congenital Factor VII deficiency.85

Efficacy in people with congenital Factor VII deficiency

Efficacy in people with congenital Factor VII deficiency chart

In nonsurgical bleeding episodes:

  • Efficacy appeared to be independent of the location of bleeding60
  • Recombinant Factor VIIa proved effective across a range of serious bleeds60

For Surgery in FVII Deficiency

Treatment with rFVIIa was rated as effective in 37 of 43 (86%) of non-surgical bleeding episodes and in all surgical procedures for which data were collected (25/26, 96%).60

For Acquired Hemophilia

NovoSeven® RT is effective for acquired hemophilia

Efficacy with Recombinant Factor VIIa treatment90

Efficacy with NovoSeven treatment chart

Adapted from Sumner et al.90
Data were extracted from a review of experiences with recombinant Factor VIIa for the treatment of acquired hemophilia from the recombinant Factor VIIa compassionate use programs, the HTRS registry, and independent published reports. Efficacy was defined by the mean time to treatment from bleeding onset to first recombinant Factor VIIa dose as determined in non-surgical bleeding episodes and is shown in the chart above for “effective” and “partially effective” treatment outcomes. “Ineffective” treatment was determined by inability to stop the bleeding episode or by the physician describing treatment as not effective.50 

  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 FVII deficiency and prevention of bleeding in surgical interventions or invasive procedures in patients with congenital FVII deficiency.

    NovoSeven® RT Important Safety Information

    • The most common adverse events of NovoSeven® RT therapy are pyrexia, hemorrhage, injection site reaction, arthralgia, headache, hypertension, hypotension, nausea, vomiting, pain, edema, and rash. The most serious adverse events observed during NovoSeven® RT therapy are thrombotic events.
    • 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® RT treatment.
    • Use with caution in patients with known hypersensitivity to NovoSeven® RT, its components, or mouse, hamster, or bovine proteins.
    • Serious adverse events that may have been related to the use of NovoSeven® RT in acquired hemophilia included thrombotic serious adverse events and death.
    • Serious adverse events that may have been related to the use of NovoSeven® RT 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® RT. These patients had previously been treated with human plasma and/or plasma-derived FVII. Factor VII deficient patients should be monitored for prothrombin time (PT) and factor VII coagulant activity before and after administration of NovoSeven® RT.
    • Concomitant use of NovoSeven® RT with other formulations of NovoSeven® is not recommended due to potential dosing errors based on different concentrations.

    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.

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.