bivalirudin: clinical use

Prescribing considerations

• Restrict use to clinicians experienced in acute coronary care or coronary intervention.
• Assess renal function because reduced clearance increases exposure and bleeding risk.
• Ensure complete dissolution, dilution, mixing, line priming and uninterrupted intravenous delivery.
• Use particular caution in older adults.
• Evidence in people with heparin-induced thrombocytopenia or thrombosis is limited.

Contraindications and cautions

• Hypersensitivity to bivalirudin, an excipient or hirudins
• Active bleeding or increased bleeding risk caused by haemostasis or irreversible coagulation disorders
• Severe uncontrolled hypertension
• Subacute bacterial endocarditis
• Severe renal impairment or dialysis dependence

Monitoring

• Observe for bleeding; unexplained reductions in haemoglobin, haematocrit or blood pressure may indicate haemorrhage.
• Check renal function and monitor more closely when renal clearance is impaired.
• Activated clotting time may help confirm procedural delivery when clinically indicated; an inadequate response should prompt checks for preparation or equipment errors.
• Monitor haemostasis when combined with anticoagulants or antiplatelets.
• With warfarin, confirm that INR returns towards its previous level after bivalirudin is stopped.
• Monitor for myocardial ischaemia and acute stent thrombosis after primary coronary intervention.

Clinical pharmacology

Bivalirudin reversibly inhibits free and clot-bound thrombin. It has immediate intravenous bioavailability, undergoes proteolytic breakdown and has a short half-life; renal impairment reduces clearance. There is no specific antidote, although it is haemodialysable.

Formulation and product differences

• The selected product is a single-use lyophilised powder requiring aseptic reconstitution and further dilution before intravenous administration.
• The prepared solution should be clear to slightly opalescent and colourless to slightly yellow; discard it if particles or abnormal discolouration are present.
• The formulation contains mannitol and sodium hydroxide and is essentially sodium-free.

Injection

Route: Parenteral

Strengths: 250 mg