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])

Therapeutic Safety

Safety Advantages with NovoSeven® RT

No Risk of Increased Titers

Low titers are clinically important in the treatment of bleeding episodes,92 for immune tolerance induction (ITI), 73,59 and in surgery.93

  • NovoSeven® RT is recombinant FVIIa and has no potential for anamnestic reaction
  • Treatment with recombinant FVIIa does not increase inhibitor titers .73

Titer levels after use with Recombinant Factor VIIa

Titer levels after use with Recombinant Factor VIIa chart.

Adapted from Brackman et al.73
Data from a study of patients with hemophilia A and high-responding inhibitors. Ten were given recombinant FVIIa for treatment of bleeds; 6 of these patients were also undergoing ITI. Figure lines reflect decreases in inhibitor titers after switch to recombinant Factor VIIa in the 4 patients not undergoing ITI.73

Low Risk of Thrombotic Events

  • Demonstrated through extensive use (>400,000 standard doses [90mcg/kg administered)91

Low incidence of adverse events with Recombinant Factor VIIa91,a
Thrombotic event No. of patients
with hemophilia
with inhibitors
Cerebrovascular thrombosis 2
Cerebrovascular accident 1
Acute myocardial infarction 7
Disseminated intravascular coagulation 2
Deep vein thrombosis
(including one pulmonary embolism)		 6
Total 18

a Thrombotic events since approval of recombinant Factor VIIa in 1996 (up to the end of 2002) in patients with inhibitors (acquired or congenital).

Low Incidence of Adverse Events

Even after extensive use (>400,000 standard doses [90 mcg/kg] administered), rate of serious adverse events with recombinant Factor VIIa was low91

The most common adverse events in people taking NovoSeven® RT are:85

  • Pyrexia
  • Hemorrhage
  • Injection site reaction
  • Arthralgia
  • Headache
  • Hypertension
  • Hypotension
  • Nausea
  • Vomiting
  • Pain
  • Edema
  • Rash

Low Risk of Drug Interactions

There have been no reported drug interactions with nonhemostatic agents, including analgesics, antibiotics, and sedatives.66

  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.