Direct Healthcare Professional Communication on approved dosing regimens for bivalirudin (Angiox®) following reports of inappropriate use

Source: MHRA Area: News The Medicines Company has issued a Direct Healthcare Professional Communication regarding bivalirudin (Angiox®, which states that the approved dosing regimen for patients undergoing percutaneous coronary intervention (PCI) must be followed (i.e. an IV bolus injection of 0.75 mg/kg body weight should be followed immediately by an IV infusion at 1.75 mg/kg/hour for at least the duration of the PCI).   Post-marketing data suggest that some patients are only treated with an IV bolus dose of bivalirudin, without the required subsequent IV infusion. Due to the short half-life of bivalirudin (25 minutes), failure to initiate an infusion following the IV bolus will result in a sub-therapeutic plasma concentration (and thus suboptimal ischaemic protection during PCI) within minutes.   The communication also includes information about the use of bivalirudin in patients with renal impairment. As approximately 20% of bivalirudin is excreted via the kidneys, the IV infusion ...
Source: NeLM - Cardiovascular Medicine - Category: Cardiology Source Type: news