NovoSeven® is the commercial brand name of Recombinant Coagulation Factor VIIa for Injection, a recombinant activated coagulation factor developed by Novo Nordisk. It binds to exposed tissue factor at bleeding sites to activate factor X and accelerate thrombin generation, thereby promoting local hemostasis.
Main Indications
Treatment of bleeding episodes and perioperative management of bleeding in patients with hemophilia A or B with inhibitors to coagulation factors VIII or IX;
Treatment of bleeding episodes and perioperative bleeding management in patients with acquired hemophilia.
Clinical Research
Global multicenter clinical trials demonstrated that recombinant factor VIIa effectively controls acute bleeding in hemophilia patients with inhibitors and reduces perioperative blood loss;
Chinese registration trials confirmed consistent hemostatic efficacy and tolerability with global study populations in Chinese patients with hemophilia complicated by inhibitors;
Long-term observational studies verified its stable hemostatic effect and manageable thromboembolic risk when used at recommended doses.
Common Side Effects
Severe but important risks: Thromboembolic events including venous thrombosis, arterial thrombosis and disseminated intravascular coagulation (DIC);
Common mild adverse reactions: Rash, fever, injection site reactions, headache and allergic reactions.
Approval Status in China
Original drug NovoSeven® (Recombinant Coagulation Factor VIIa for Injection, specification: 1mg (50KIU)/vial) was officially approved for marketing in China in 1999. It is currently a prescription hemostatic biologic drug included in China’s category B medical insurance catalogue.
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