human coagulation factor VIII + von willebrand factor: clinical use

Prescribing considerations

• Treatment requires supervision by a clinician experienced in haemophilia.
• Record the product name and batch number after every administration for biological traceability.
• Consider cardiovascular risk factors and complications associated with central venous access.
• Donor selection, screening and viral-reduction measures reduce infection risk, but transmission of known or emerging infectious agents cannot be completely excluded.
• Consider hepatitis A and B vaccination with repeated plasma-derived factor VIII treatment.
• Account for sodium content and possible polysorbate-associated allergic reactions.

Contraindications and cautions

• Hypersensitivity to human coagulation factor VIII, von Willebrand factor or any excipient.

Monitoring

• Assess clinical haemostatic response and plasma factor VIII activity, particularly during major surgery.
• Interpret one-stage and chromogenic factor VIII assays carefully because results may differ between methods, reagents and laboratories.
• Test for factor VIII inhibitors if expected factor levels are not reached or bleeding remains uncontrolled.
• Monitor for hypersensitivity and, where applicable, central-line infection or thrombosis.

Clinical pharmacology

Factor VIII binds circulating von Willebrand factor and, once activated, acts as a cofactor for activated factor IX in factor X activation, leading to thrombin generation and fibrin formation. The infused proteins act like their endogenous plasma counterparts.

Formulation and product differences

• Plasma-derived high-purity factor VIII concentrate containing von Willebrand factor.
• Supplied as powder with water for injections and either a filter needle or Mix2Vial transfer device.
• Contains sodium, polysorbate 20 and trehalose. Check current-pack latex information where clinically relevant.
• Must not be mixed with other medicines and should be administered using the supplied equipment.