glossary

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.