Uses

Used for the treatment and prophylaxis of bleeding in patients with hemophilia A and von Willebrand disease. Replaces deficient or dysfunctional clotting factors to control hemorrhagic episodes.

Do not use if

Contraindicated in patients with known hypersensitivity to mouse or hamster proteins (if product is derived from cell cultures using these species). Contraindicated if patient has known hypersensitivity to any component.

Side effects

May cause allergic or anaphylactic reactions, fever, chills, and injection site reactions. Development of inhibitory antibodies (inhibitors) against factor VIII is a major complication in hemophilia A treatment.

Warnings

Monitor patients for development of factor VIII inhibitors, particularly during early treatment. Allergic reactions including anaphylaxis can occur; have epinephrine available. Use with caution in patients with cardiovascular risk factors due to potential thrombotic risk.

How it works

Coagulation factor VIII is an essential cofactor in the intrinsic coagulation pathway, required for the activation of factor X. Von Willebrand factor stabilizes factor VIII in plasma and mediates platelet adhesion to damaged vascular endothelium, facilitating primary hemostasis.

Storage

Store refrigerated at 2–8°C. Do not freeze. Protect from light. May be stored at room temperature (up to 25°C) for a limited period as specified in the product label.