Coagulation Factor VIII Powder for Injection 500 IU

Description

Active Ingredient: Contains 500 International Units (IU) of human Coagulation Factor VIII, also known as anti-hemophilic factor (AHF).¹
Formulation: It is supplied as a sterile, lyophilized (freeze-dried) powder that must be reconstituted with a specific diluent before administration.²
Source: This product can be either derived from human plasma (plasma-derived) or manufactured using recombinant DNA technology (recombinant Factor VIII).
Concentration: The final concentration after reconstitution is typically 100 IU/mL, providing a potent solution for intravenous infusion.

Higher Dose: The 500 IU strength allows for more convenient administration of higher doses, particularly in the management of severe bleeding episodes or for larger patients.
Targeted Hemophilia A Treatment: Provides a precise and effective way to replace the missing or deficient Factor VIII, which is the underlying cause of hemophilia A, to control and prevent bleeding.
Effective Prophylaxis: Can be used for long-term prophylaxis to prevent recurrent bleeding episodes in patients with severe hemophilia A, which helps to preserve joint health and improve quality of life.
On-Demand Bleeding Control: Offers a rapid and reliable method to treat acute bleeding events, such as spontaneous hemorrhages or those resulting from trauma.

Hemophilia A: The primary and most common indication is for the control and prevention of bleeding in patients with congenital Factor VIII deficiency (Hemophilia A).
Prophylaxis: Indicated for routine prophylaxis in hemophilia A to prevent recurrent bleeding, particularly into joints and muscles (hemarthrosis), which can cause permanent damage.³
Surgical Management: Used to manage perioperative bleeding in hemophilia A patients undergoing surgery or other invasive procedures, ensuring adequate hemostasis.
Von Willebrand Disease: Certain Factor VIII products that also contain von Willebrand factor (VWF) can be used to treat bleeding in patients with specific types of von Willebrand disease where Factor VIII replacement is needed.⁴

Intrinsic Coagulation Pathway: Coagulation Factor VIII is a critical protein in the intrinsic pathway of the blood coagulation cascade. It circulates in the blood bound to von Willebrand factor (VWF), which protects it from premature degradation.⁵
Cofactor Activation: Upon activation, it becomes Factor VIIIa, which acts as a non-enzymatic cofactor. It forms a complex with activated Factor IX (Factor IXa) to activate Factor X, a crucial step in the coagulation cascade.⁶
Mechanism of Action: By replacing the deficient Factor VIII, the administered product restores this critical cofactor function. This enables the proper and timely formation of fibrin, which stabilizes a blood clot and stops hemorrhage.
Risk of Inhibitors: A significant characteristic of Factor VIII products is the potential for the patient’s immune system to develop neutralizing antibodies (inhibitors). The presence of inhibitors can render the product ineffective, making bleeding difficult to control.⁷

Unreconstituted Powder: The lyophilized powder for injection should be stored refrigerated at a temperature of 2∘C to 8∘C (36∘F to 46∘F).
Protection from Light: It must be kept in its original packaging, protected from light, to maintain the stability of the Factor VIII protein.
Reconstitution & Immediate Use: The product must be reconstituted with the provided sterile diluent immediately before use. The reconstituted solution should be administered within a few hours (typically within 3 hours) to ensure the full potency of the factor.
No Freezing/Refrigeration Post-Reconstitution: The reconstituted solution should not be frozen or refrigerated. Any unused portion must be safely discarded as the product does not contain preservatives.