NOVOMEDLINK™

Convenience

Convenience Features of NovoSeven® RT

NovoSeven® RT and NovoSeven® are bioequivalent. NovoSeven® RT has these added convenience features.

  • Room–Temperature Stable Formulation
    NovoSeven® RT can be safely kept at room temperature or refrigerated (36ºF–77ºF, 2ºC–25ºC).
  • Rapid Reconstitution
    NovoSeven® RT dissolves rapidly and takes only minutes to prepare.
  • Fast Infusion Time
    Infusing NovoSeven® RT takes only 2 to 5 minutes.

Administration time (minutes)

2-5 minutes clock graphic
NovoSeven® RT
2-5
42 minutes clock graphic
aPCC86,*
42

*aPCC= activated prothrombin complex concentrate

  • Low-Volume Infusion
    NovoSeven® RT has 40% less infusion volume compared to NovoSeven®.
    • 94% less infusion volume compared to aPCC

Low-volume infusion with NovoSeven® RT79,85,86

7.2 cc beaker graphic
NovoSeven® RT85
7.2 cc
12 cc beaker graphic
NovoSeven®79
12 cc
120 cc beaker graphic
aPCC86
120 cc
  • Simplified Dose Calculation

    NovoSeven® RT now is in 1.0 mg, 2.0 mg, and 5.0 mg vial sizes. Color-coded vials match corresponding diluent vials for simplified reconstitution.

Conversion chart
  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.

  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.