catridecacog: clinical use

Prescribing considerations

• Confirm congenital factor XIII A-subunit deficiency using appropriate activity and immunological testing, with genotyping where applicable.
• Distinguish A-subunit from B-subunit deficiency; catridecacog is not effective for long-term prophylaxis in congenital B-subunit deficiency.
• Assess thrombotic predisposition, hepatic impairment and previous hypersensitivity.
• Clinical experience is limited in older people, and patients requiring dialysis have not been studied.
• Plan invasive or dental procedures with the specialist haemophilia service.

Contraindications and cautions

• Hypersensitivity to catridecacog or any excipient.
• Known neutralising factor XIII antibodies require close specialist monitoring rather than routine use.

Monitoring

• Factor XIII activity, particularly when protection appears inadequate or severe hepatic impairment is present.
• Breakthrough bleeding and clinical response.
• Factor XIII antibodies if expected activity is not achieved or bleeding suggests an inhibitor.
• Signs of hypersensitivity or thrombosis.
• Product name and batch number for biological traceability.

Clinical pharmacology

Catridecacog is a yeast-produced recombinant protein structurally identical to the human factor XIII A-subunit. It associates with endogenous B-subunits and is activated by thrombin in the presence of calcium, then cross-links fibrin and strengthens clot adhesion.

Formulation and product differences

• Supplied as a powder with a separate solvent and vial adapter for intravenous injection.
• Concentration and administration calculations differ from other factor XIII-containing products; they are not directly interchangeable.
• Further dilution may be required in small children for accurate administration of small volumes.
• The prepared product must be used immediately, administered separately and not added to an infusion.

Injection

Route: Parenteral

Strengths: 2500 units