Factor VIIa (Recombinant)
Class: Hemostatics
VA Class: BL500
Chemical Name: Blood-coagulation factor VII (human clone λHVII2463 protein moiety)
Molecular Formula: C1982H3054N560O618S28
CAS Number: 102786-61-8
Brands: NovoSeven RT
Warning
Risk of serious arterial and venous thromboembolic adverse events, particularly when factor VIIa (recombinant) is used outside FDA-labeled indications. (See Thromboembolic Events under Cautions.)
Both fatal and nonfatal thromboembolic events have been reported in clinical studies and during postmarketing experience.
Discuss risk of thromboembolism with patient. Monitor for signs and symptoms of coagulation system activation and thrombosis during therapy.
Introduction
Biosynthetic preparation (recombinant DNA origin) of blood coagulation factor VIIa.
Uses for Factor VIIa (Recombinant)
Hemophilia A or B with Inhibitors
Treatment and prevention of hemorrhagic episodes in patients with hemophilia A (antihemophilic factor [factor VIII] deficiency; classic hemophilia) or hemophilia B (factor IX deficiency; Christmas disease) who have developed inhibitors (alloantibodies) to factor VIII or factor IX, respectively; designated an orphan drug by FDA for this use.
Prevention of bleeding in patients with hemophilia A or B with inhibitors to factor VIII or factor IX, respectively, undergoing surgery or invasive procedures; designated an orphan drug by FDA for this use.
Management of hemophilia in patients with inhibitors may be difficult and consultation with a hemophilia treatment center is strongly recommended.
The Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation and other experts state that factor VIIa (recombinant) is one of several therapeutic options for the management of hemophilic patients with inhibitors. Treatment of choice depends on several factors (e.g., severity and location of bleeding, type [low- or high-responding] and titer of inhibitor, history of anamnestic response, previous response to these preparations).
Patients with low titers (e.g., <5–10 Bethesda units/mL) of inhibitors may be effectively treated with high dosages of coagulation factor concentrates (factor VIII or factor IX). Bypassing agents (e.g., factor VIIa [recombinant]) generally are used when a response to specific factor replacement therapy has not been obtained or is unlikely. MASAC recommends use of a bypassing agent in hemophilia A or hemophilia B patients with inhibitors in settings where clotting factor preparations would otherwise be used, including before and after surgery and physical therapy.
Acquired Hemophilia
Treatment and prevention of bleeding in patients with acquired hemophilia (i.e., those with acquired inhibitor antibodies [autoantibodies] to factor VIII); designated an orphan drug by FDA for this use.
Prevention of bleeding in patients with acquired hemophilia undergoing surgery or invasive procedures; designated an ...
