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

Dosing & Administration

Dosing Guidelines

NovoSeven® RT should be given as early as possible after the start of a bleeding episode. Be sure to follow recommended dosing to ensure optimal efficacy.

Treatment of Bleeding Episodes—Recommended dosing of NovoSeven® RT
Hemophilia A or B with inhibitors 90 mcg/kg every 2 hours until bleeding resolves
Congenital Factor VII deficiency 15 to 30 mcg/kg every 4 to 6 hours until bleeding resolves
Acquired Hemophilia 70 to 90 mcg/kg every 2 to 3 hours until bleeding resolves

Surgery—Recommended dosing of NovoSeven® RT
Hemophilia A or B with inhibitors Preoperative and intraoperative 90 mcg/kg immediately prior to surgery. Repeat 90 mcg/kg dose every 2 hours during surgery

Hemophilia A or B with inhibitors

 Postoperative—Major Surgery 90 mcg/kg every 2 hours for 5 days. After 5 days, 90 mcg/kg every 4 hours until healing has occurred.

Hemophilia A or B with inhibitors

 Postoperative—Minor Surgery 90 mcg/kg every 2 hours for the first 48 hours. After 48 hours, 90 mcg/kg every 2 to 6 hours until healing has occurred.
Congenital Factor VII deficiency Intraoperative and postoperative dosage—Major and minor surgery 15 to 30 mcg/kg every 4 to 6 hours until bleeding resolves

NovoSeven® RT Dosing Calculator

Administration

NovoSeven® RT is intended for intravenous bolus administration only.

Reconstitution
NovoSeven® RT is reconstituted with the included diluent (a solution containing a histidine buffer). NovoSeven® RT dissolves rapidly and can be used up to 3 hours after reconstitution.

Infusion
NovoSeven® RT is administered as a slow bolus injection over 2 to 5 minutes, depending on the dose administered.

  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.