Used for the treatment and prevention of bleeding episodes in patients with haemophilia A. It is also indicated for prophylactic use in individuals with severe haemophilia A.

Factor VIII plays a crucial role in the blood clotting process and the maintenance of haemostasis. It works together with activated factor IX to activate factor X. Activated factor X then converts prothrombin into thrombin, which subsequently converts fibrinogen into fibrin, leading to the formation of a stable clot with the help of factor XIII. Factor VIII is used as replacement therapy in patients with haemophilia A.

Treatment and prophylaxis of haemorrhagic episodes in patients with haemophilia A: Dosage is individualised based on coagulation tests performed before treatment and at regular intervals during treatment. Generally, 1 IU/kg will increase circulating factor VIII levels by about 2 IU/dL. Recommended doses vary according to the preparation used

Suggested doses: Mild-moderate haemorrhage (increase to 20-30% of normal): Usually with a single dose of 10-15 IU/kg

More serious haemorrhage or minor surgery (increase to 30-50% of normal): Usual initial dose of 15-25 units/kg followed by 10-15 IU/kg every 8-12 hr if required

Severe haemorrhage or major surgery (increase to 80-100% of normal): Usual initial dose of 40-50 IU/kg followed by 20-25 IU/kg every 8-12 hr. Refer to individual product information for further dosing details

Prophylaxis in severe haemophilia A: 10-50 IU/kg every 2-3 days, as needed

Hypersensitivity reactions may occur, including chills, chest tightness, fever, headache, increased fibrinogen levels, restlessness, lethargy, nausea, vomiting, drowsiness, injection site irritation, abdominal discomfort, tingling sensations, urticaria, and vasomotor reactions, particularly with rapid infusion.

Contraindicated in individuals with a history of anaphylactic or severe systemic reactions to antihaemophilic factor or von Willebrand factor preparations.

Adverse effects may include chills, chest discomfort, fever, headache, elevated fibrinogen levels, restlessness, lethargy, nausea, vomiting, drowsiness, injection site irritation, abdominal pain, tingling, urticaria, and vasomotor reactions, especially with rapid infusion.

Pregnancy Category C: Animal studies have shown adverse effects on the fetus, and there are no adequate and well-controlled studies in pregnant women. The drug should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus.

There is a risk of intravascular hemolysis in patients with blood groups A, B, or AB receiving high or repeated doses of factor VIII preparations. There is also a potential risk of transmission of viral infections, particularly hepatitis B and C. Dosage requirements may vary in patients with factor VIII inhibitors; treatment should be guided by clinical response. Regular monitoring of platelet count is recommended during therapy.

Antihaemophilic factor.

Store at 2–8°C. Use within 3 hours after reconstitution. Do not refrigerate after reconstitution due to the risk of precipitation.