Catridecacog (Recombinant Coagulation Factor Xiii)

What it is and how it works

Catridecacog is a recombinant FXIII A2 dimer that combines with the patient’s endogenous FXIII B-subunits to form active FXIII. Activated by thrombin, it cross-links fibrin and other proteins, stabilising the fibrin clot and increasing its resistance to fibrinolysis.

Indications

Long-term prophylaxis of bleeding in patients with congenital factor XIII A-subunit deficiency.

Dosage and administration (summary)

Dosing is individualised by the specialist: given by slow intravenous injection, typically 35 IU/kg once monthly (every 4 weeks), adjusted according to FXIII activity levels.

Contraindications

Hypersensitivity to the active substance or any excipient; congenital FXIII B-subunit deficiency (not effective).

Warnings and precautions

Hypersensitivity reactions may occur. Inhibitory antibodies against FXIII have been reported; lack of response should prompt testing. Use with caution in patients at increased risk of thrombosis, as thrombotic events are a theoretical risk; FXIII B-subunit deficiency should be excluded before use.

Pregnancy

Use in pregnancy only if clearly needed; limited data are available.

Storage and supply

Store at 2–8 °C in the outer carton, protected from light; do not freeze; use reconstituted solution promptly.

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