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Synthetic analog by recombinant technology of natural hirudin consisting of a polypeptide chain of 65 amino acids.
It is a thrombin inhibitor; it inhibits platelet aggregation and fibrinogen formation.
Indicated for the prevention of deep vein thrombosis in patients undergoing elective hip and knee replacement surgery.
Subcutaneous administration twice a day for a maximum of 12 days.
At the date of the last update, there was no available published data on its excretion in breast milk.
Its high molecular weight and absolute fixation to plasma thrombin make it unlikely to pass into breast milk in a clinically significant amount.
Due to its protein nature, it is inactivated in the gastrointestinal tract, not being absorbed (practically nil oral bioavailability), which hinders or prevents the passage into plasma of the infant from ingested breast milk except in the premature and during the immediate neonatal period, during which there may be increased intestinal permeability.
It was withdrawn from the market in 2014 for commercial reasons (EMA 2014).