factor VIII: clinical use

Prescribing considerations

• Initiate and supervise treatment through clinicians experienced in haemophilia care.
• Assess clinical response individually because recovery and pharmacokinetics vary.
• Consider cardiovascular risk and complications associated with central venous access devices.
• Record the product name and batch number after each administration.
• Consider the product's sodium content where sodium intake is clinically important.

Contraindications and cautions

• Hypersensitivity to turoctocog alfa or any excipient.
• Known allergic reaction to hamster proteins.

Monitoring

• Assess bleeding control and factor VIII activity using an appropriate validated assay.
• Test for factor VIII inhibitors when expected activity is not reached or bleeding is inadequately controlled.
• Monitor for hypersensitivity during administration.
• Monitor central venous access devices for infection, bacteraemia and catheter-site thrombosis where applicable.

Clinical pharmacology

Turoctocog alfa is a B-domain-truncated recombinant human factor VIII produced in Chinese hamster ovary cells. Activated factor VIII promotes factor X activation and subsequent thrombin and fibrin formation.

Formulation and product differences

• The selected product is a recombinant factor VIII powder supplied with a pre-filled sodium chloride solvent syringe and vial adapter.
• No human- or animal-derived protein is added during cell culture, purification or final formulation, although traces of hamster protein may remain.
• The reconstituted product is for intravenous use and must not be mixed with other medicines.

Injection

Route: Parenteral

Strengths: 250 units, 500 units, 1000 units, 1500 units, 2000 units, 3000 units