Hemophilia A - Hemorrhage.

Antihemophilic Factor VIII (Recombinant)(Xyntha) is a purified glycoprotein consists of 1438 amino acids. Recombinant Factor VIII temporarily replaces the missing clotting factor VIII that is needed for effective hemostasis by facilitating the activation of Factor X ultimately causing the formation of thrombin and fibrin promoting platelet aggregation and adhesion to damaged vascular endothelium.

Distribution
Vd, adult: 66.1 to 69 mL/kg; pediatric: 66.9 to 67.1 mL/kg; 0.43 to 0.54 dL/kg.
Excretion
Total body clearance, adult: 3.48 to 4.51 mL/hr/kg; pediatric: 6.29 to 6.62 mL/hr/kg.
Elimination Half Life
Adult, 11.2 to 16.7 hours; Pediatric, 6.9 to 11.7 hours.

Life-threatening immediate hypersensitivity, including anaphylaxis, to antihemophilic factor VIII or to any product component, including mouse or hamster protein.

C (FDA)

Infant risk is minimal.

Common:
Musculoskeletal: Arthralgia (12% to 25%), Traumatic injury, Limb (10%)
Neurologic: Headache (21% to 26%)
Respiratory: Cough (11% to 19%), Nasopharyngitis (17%)
Other: Fever (21%)
Serious:
Immunologic: Anaphylaxis, Factor VIII inhibitor disorder (4.17%), Hypersensitivity reaction.

Hemophilia A - Hemorrhage, Control and prevention:
Minor bleeding, 10 to 20 international units/kg IV to increase the circulating antihemophilic factor to 20% to 40% of normal every 12 to 24 hours as necessary until resolved, for at least 1 day.
Moderate bleeding, 15 to 30 international units/kg IV to increase the circulating antihemophilic factor to 30% to 60% of normal every 12 to 24 hours for 3 to 4 days or until adequate local hemostasis is achieved.
Major bleeding; 30 to 50 international units/kg IV to increase the circulating antihemophilic factor to 60% to 100% of normal every 8 to 24 hours until bleeding is resolved.
Hemophilia A - Hemorrhage; Prophylaxis - Surgical procedure:
Minor surgery, 15 to 30 international units/kg IV to increase the circulating antihemophilic factor to 30% to 60% of normal, repeat every 12 to 24 hours for 3 to 4 days or until local hemostasis is achieved; for tooth extraction, single IV infusion plus adjunctive oral antifibrinolytic therapy within 1 hour of surgery may be adequate.
Major surgery, 30 to 50 international units/kg IV to increase the circulating antihemophilic factor to 60% to 100% of normal, repeat infusions every 8 to 24 hours until wound healing and local hemostasis are achieved.