Coagulation Factor Viii, Long Acting

What it is and how it works

Recombinant factor VIII modified to prolong its circulating half-life, for example by fusion to the Fc domain of IgG1 or by PEGylation. It replaces deficient factor VIII and restores haemostasis, allowing less frequent prophylactic dosing than standard factor VIII products.

Indications

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).

Dosage and administration (summary)

Dosing and prophylaxis interval are individualised by the haemophilia specialist according to bleeding phenotype, pharmacokinetics and clinical response; given by intravenous injection.

Contraindications

Known hypersensitivity to the active substance, to any excipient or, depending on the product, to hamster or mouse proteins.

Warnings and precautions

Inhibitors to factor VIII may develop and should be suspected if bleeding is not controlled with the expected dose. Hypersensitivity reactions, including anaphylaxis, may occur. Cardiovascular risk factors may be unmasked when haemostasis is normalised in older patients.

Pregnancy

Experience in pregnancy is limited; use only if clearly indicated.

Storage and supply

Store refrigerated at 2–8 °C, do not freeze, protect from light; a single limited period at room temperature is usually permitted as specified by the manufacturer.

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