Cathflo® Activase® (Alteplase) is indicated for the restoration of function to central venous access devices (CVADs) as assessed by the ability to withdraw blood.
Status Cathflo Activase was approved by the FDA in September 2001, and later approved in pediatric patients in January 2005. Cathflo Activase, available in a 2 mg single-patient-use vial, is the only marketed thrombolytic available for this indication and offers medical professionals a viable treatment option for a CVAD complication that can hinder patient care.
Mechanism of Action Cathflo Activase is a thrombolytic that works by targeting fibrin (the substance that causes blood to clot), dissolving the thrombus (blood clot) and restoring function to the central venous access device (CVAD).
Central Venous Access Device (CVAD) It is estimated that 5 million catheters are placed each year in the U.S., and occlusions are a frequent complication. It is estimated that up to 25 percent of all CVADs become occluded and that 60 percent of those occlusions are caused by thrombosis, the formation of a blood clot.
Safety The COOL-2 trial, a Phase IIIb, single arm, open-label study, enrolled 995 pediatric (2yr + <10kg) and adult patients with CVAD occlusion present for any duration to determine the safety of Cathflo Activase for restoring function to CVADs occluded due to a blood clot. In clinical trials, the most serious adverse events reported after treatment were sepsis, gastrointestinal bleeding and venous thrombosis.
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