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])

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 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.