defibrotide: clinical use

Prescribing considerations

• Restrict initiation and administration to specialist teams experienced in HSCT complications.
• Do not use for routine prophylaxis of VOD after HSCT.
• Assess active bleeding, haemodynamic stability, concomitant haemostatic medicines and planned invasive procedures.
• Record the product name and batch number for traceability.
• Consider sodium exposure where clinically relevant.

Contraindications and cautions

• Hypersensitivity to defibrotide or an excipient.
• Concurrent thrombolytic therapy, such as tissue plasminogen activator.

Monitoring

• Monitor closely for overt or occult haemorrhage and falling blood pressure.
• Review coagulation parameters when antithrombotic treatment is exceptionally unavoidable.
• Carefully monitor patients with hepatic impairment.

Clinical pharmacology

Defibrotide has antithrombotic, profibrinolytic, anti-adhesive and anti-inflammatory effects centred on endothelial homeostasis. It is rapidly cleared, shows no meaningful accumulation in pharmacokinetic modelling and does not inhibit or induce CYP450 enzymes.

Formulation and product differences

• The product is a porcine intestinal-mucosa-derived sterile concentrate for intravenous infusion.
• It requires dilution with compatible sodium chloride or glucose infusion solution and is supplied in single-use vials.
• The concentrate contains sodium and must not be frozen.

Solution for infusion

Route: Intravenous

Strengths: 80 mg/mL