caplacizumab: clinical use

Prescribing considerations

• Initiate and supervise treatment within a specialist thrombotic microangiopathy service.
• Assess bleeding risks, including concurrent anticoagulants, antiplatelets, thrombolytics, heparins and underlying coagulopathies.
• Coordinate planned surgery, dental procedures and other invasive interventions with the treating specialist.
• Record the product name and batch number for biological traceability.
• Severe hepatic impairment requires individual benefit–risk assessment and close monitoring because clinical data are unavailable.

Contraindications and cautions

• Hypersensitivity to caplacizumab or any formulation excipient.

Monitoring

• Monitor clinically for bleeding, particularly when other therapies affecting haemostasis are used.
• Follow platelet response and underlying immune disease activity, including ADAMTS13 activity where used by the specialist service.
• Interrupt treatment for clinically significant bleeding and seek expert guidance before restarting.
• Monitor closely after resumption following surgery or significant bleeding.

Clinical pharmacology

Caplacizumab is a humanised bivalent single-domain antibody fragment targeting the von Willebrand factor A1 domain. It has target-mediated, non-linear pharmacokinetics. Target-bound medicine is thought to undergo hepatic catabolism, while unbound medicine is thought to be cleared renally. Pharmacodynamic effects include transient reductions in von Willebrand factor antigen and factor VIII activity.

Formulation and product differences

• Single-use powder supplied with water for injections in a pre-filled syringe; reconstitution is required before intravenous or subcutaneous administration.
• The reconstituted solution should be clear, colourless or slightly yellow without visible particles.
• It must not be mixed with other medicinal products.
• The formulation is essentially sodium-free.

Injection

Route: Parenteral

Strengths: 10 mg