Boehringer Ingelheim launched Actilyse Cathflo 2mg, a low-dose vial of the thrombolytic alteplase. Actilyse Cathflo 2mg is used to restore the patency of central venous access devices, including those used in haemodialysis. The launch was held at the National Infusion and Vascular Access Society (NIVAS) annual conference on 16 June 2011.
Actilyse Cathflo 2mg (active ingredient: alteplase), a recombinant tissue plasminogen activator (rt-PA), is a genetically engineered version of naturally occurring tissue plasminogen activator, which has the biological function of removing small clots that routinely form in the bloodstream.
When administered intravenously, alteplase remains relatively inactive in the circulatory system. Once bound to fibrin, it is activated, inducing the conversion of plasminogen to plasmin leading to the dissolution of the fibrin clot and breaking down the thrombus and restoring function to the central venous access devices. Once the clot has broken down, any debris can be aspirated from the central venous access devices. The devices remain in situ during the process and can be re-used once clear.
Central venous catheterisation is a key component of the treatment of patients who are undergoing procedures such as haemodialysis. According to David Ansell et al, over 20,000 patients are currently receiving dialysis in the United Kingdom. It is estimated that up to 25% of central venous access devices become occluded, according to Haire WD et al, and it is estimated that 58% of central venous access devices blockages are caused by blood clots.
When central venous access devices become occluded, administration of critical therapies may be delayed until the blockage is cleared or the device is replaced. Current treatments for occlusion include removing and replacing the central venous access device. Salvaging the device is the preferred method of managing occlusions as these results in limited interruptions to therapy, reduced risk of complications, reduced trauma for patients and decreased costs.
Three pivotal studies have confirmed the safety and efficacy of Actilyse Cathflo 2mg in restoration of function to central venous access devices. The studies enrolled more than 1,400 patients of all ages including 310 children and adolescents in the age of two weeks up to 17 years. In the COOL and COOL-2 (Cardiovascular thrombolytic to open occluded lines) trials, 74-77% of patients with occlusions had restored function after one dose and 87-90% had function restored after two doses of alteplase 2mg using a 120 minute dwell time for each dose. The CAPS (Cathflo activase pediatric study) investigated the use of Actilyse Cathflo 2mg in paediatric patients and reported restoration rates after one and two doses, each with a maximum dwell time of 120 minutes, of 75% and 83% respectively.
The safety profile of Actilyse Cathflo 2mg has also been found to be favourable in this patient cohort. Serious adverse events observed in the COOL and COOL-2 clinical trials included intracranial haemorrhage (0.0%), embolic events (0.0%), gastrointestinal bleeding (0.3%), thrombosis (0.3%), and sepsis (0.4%). The overall safety and efficacy of Actilyse Cathflo 2mg appeared similar in children as in adults.
Actilyse (alteplase) is registered in over 85 countries across the world. It is marketed already by Boehringer Ingelheim outside the USA, Canada and Japan for the indications acute myocardial infarction, acute massive pulmonary embolism, and acute ischaemic stroke. In the USA, alteplase is marketed by Genentech, under the tradename Activase and for central venous access devices clearance under the tradename Activase Cathflo. Alteplase is also available in Canada where it is marketed by Roche Canada.