Uses

Coagulation factor IX is indicated for the control and prevention of bleeding episodes in patients with hemophilia B (congenital factor IX deficiency). It is used for perioperative management and routine prophylaxis.

Do not use if

Contraindicated in patients with known hypersensitivity to factor IX products or any component of the formulation. Use with caution in patients with signs of fibrinolysis or disseminated intravascular coagulation.

Side effects

Side effects may include hypersensitivity reactions (including anaphylaxis), inhibitor development (antibodies against factor IX), thromboembolism, and nephrotic syndrome in patients who develop inhibitors. Headache and injection site discomfort may also occur.

Warnings

Risk of thromboembolic events when combined with activated prothrombin complex concentrates. Monitor for signs of inhibitor development. Products derived from human plasma carry a theoretical risk of transmitting infectious agents.

How it works

Factor IX is a vitamin K-dependent serine protease that participates in the intrinsic pathway of blood coagulation. It is activated by factor XIa or by the extrinsic tenase complex, and in turn activates factor X, ultimately leading to thrombin generation and fibrin clot formation.

Storage

Store refrigerated at 2–8°C or at room temperature up to 25°C for a limited period as specified in product labeling. Do not freeze. Protect from light.