Alteplase Approved in European Union for Catheter Dysfunction Caused by Thrombotic Occlusion

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Title: Alteplase Approved in European Union for Catheter Dysfunction Caused by Thrombotic Occlusion
URL: http://www.pslgroup.com/dg/222A06.htm
Doctor's Guide
May 30, 2008

INGELHEIM, Germany -- May 30, 2008 -- The European Union has approved alteplase (Actilyse) 2 mg for the thrombolytic treatment of occluded central venous access devices (CVAD), including those used for haemodialysis.

Alteplase works by activating plasminogen, which dissolves fibrin, breaking down the thrombus and restoring function to the CVAD.

The efficacy of alteplase 2 mg in restoration of function to CVADs implanted in patients was studied in 2 key clinical studies. Across these pivotal trials, 75% of patients with occlusions present for less than 14 days had restored function after 1 dose, and 85% had function restored after up to 2 doses. The safety profile of alteplase 2 mg has been found to be very favourable in this critically ill patient cohort who require CVAD treatment.

A dose of up to 2 mg of alteplase administered up to 2 times into the occluded CVAD, can restore function of catheters, including those used for haemodialysis, which become dysfunctional due to thrombotic occlusion.

SOURCE: Boehringer Ingelheim GmbH

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