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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.
