Coagulation Factor Viii (Recombinant)

What it is and how it works

Purified human coagulation factor VIII prepared from pooled plasma and subjected to viral inactivation/removal steps. It temporarily replaces the missing or deficient factor VIII, which acts as a cofactor for factor IXa in activating factor X, thereby restoring thrombin generation and clot formation.

Indications

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency); some products are also authorised for von Willebrand disease when they contain sufficient von Willebrand factor.

Dosage and administration (summary)

Dosing is individualised by the haemophilia specialist according to the severity of deficiency, site and extent of bleeding, clinical condition and factor VIII recovery; given by slow intravenous injection.

Contraindications

Known hypersensitivity to the active substance or to any excipient, including residual proteins from the manufacturing process.

Warnings and precautions

Neutralising antibodies (inhibitors) to factor VIII may develop, particularly in previously untreated patients; patients should be monitored clinically and by laboratory tests. Allergic-type hypersensitivity reactions can occur. As a plasma-derived product, the possibility of transmitting infectious agents cannot be totally excluded.

Pregnancy

Experience in pregnancy is limited because haemophilia A is rare in women; use only if clearly indicated.

Storage and supply

Store refrigerated at 2–8 °C, do not freeze, protect from light; many products permit a limited period at room temperature as stated by the manufacturer.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.