urokinase: clinical use

Prescribing considerations

• Restrict use to hospital settings with appropriate diagnostic, resuscitation and monitoring facilities.
• Balance expected benefit against bleeding risk, particularly after recent procedures, in severe cerebrovascular disease, potential genitourinary bleeding or advanced age.
• Avoid unnecessary venepuncture, intramuscular injections and invasive handling during treatment.
• Experience in paediatric thromboembolic vascular disease is very limited; the licensed paediatric context is thrombosed central venous catheters.

Contraindications and cautions

• Active clinically relevant bleeding or recent severe gastrointestinal bleeding
• Recent major surgery, major trauma or cerebrovascular accident
• Severe hypertension, severe thrombocytopenia or significant coagulation defects
• Severe hepatic or renal insufficiency unless renal replacement therapy is being used
• Aneurysm, arteriovenous malformation or a tumour carrying substantial haemorrhage risk
• Acute pancreatitis, pericarditis, bacterial endocarditis or sepsis
• Recent obstetric delivery or hypersensitivity to the product

Monitoring

• Before systemic thrombolysis, assess coagulation tests, haematocrit and platelet count.
• Monitor clinically for bleeding, including puncture sites, wounds, urine and neurological changes.
• Follow circulating fibrinogen and fibrinogen-degradation products, recognising that these do not reliably predict efficacy or bleeding.
• Stop treatment and institute appropriate haemorrhage management if severe bleeding occurs.

Clinical pharmacology

Urokinase is a serine protease that activates plasminogen to plasmin, producing fibrinolysis. It is rapidly cleared mainly by the liver; inactive products are excreted through the kidneys and bile, with delayed elimination in hepatic or renal impairment.

Formulation and product differences

• Available as single-vial white powders for injection or infusion in several strengths.
• The active material is highly purified urokinase obtained from human urine.
• Reconstitute only with the specified sodium chloride solution and use the prepared solution immediately.
• The product is essentially sodium-free and must not be mixed with other medicinal products.