NovoSeven

NovoSeven is a brand name for recombinant activated coagulation factor VII (rFVIIa), produced by Novo Nordisk. It is used to control and prevent bleeding episodes in people with hemophilia A or B who have developed inhibitors to factor VIII or IX. In some regions, it is also approved for other bleeding disorders and off-label uses may be exercised by clinicians based on regulatory guidelines and patient needs.

Mechanism of action: rFVIIa promotes hemostasis by directly activating factor X on the surface of activated platelets, leading to thrombin generation and clot formation. This action can bypass the need for factors VIII or IX, allowing effective clotting in patients with inhibitors.

Medical uses: The primary indication is management of bleeding episodes in individuals with hemophilia A or B who have developed antibodies to factors VIII or IX. Depending on regulatory approvals, it may be used in other congenital or acquired bleeding conditions or in surgical settings where rapid hemostasis is required, under specialist supervision.

Administration and dosing: NovoSeven is given by intravenous injection or infusion in a hospital setting. Dosing is tailored to the indication, patient weight, and clinical response, and treatment is typically reserved for active bleeding or perioperative management as directed by a physician.

Safety and precautions: Potential adverse events include thromboembolic events (such as deep vein thrombosis or stroke), hypersensitivity reactions, headaches, and fever. Because of thrombotic risk, use requires careful patient selection and monitoring, particularly in those with cardiovascular risk factors or a history of thrombosis. It is contraindicated in individuals with known hypersensitivity to the active product or excipients.

Regulatory status: NovoSeven is a prescription medication marketed by Novo Nordisk and has been approved in multiple countries for the management of bleeding in hemophilia patients with inhibitors. In some markets, a formulation marketed as NovoSeven RT is available.