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In developing INTERCEPT™, hundreds of ultraviolet-activated molecules called ‘psoralens’ were evaluated for their chemical and biological characteristics in regard to the decontamination of platelet and plasma blood products. Amotosalen was selected based on its activity against a wide variety of pathogenic viruses and bacteria while maintaining the functional properties of platelets and plasma. The safety and efficacy of treated platelets and plasma were extensively evaluated prior to product approval, and these findings have been supported by subsequent haemovigilance programmes and several clinical trials.
In addition, haemovigilance programmes tracking the routine use of over 200,000 INTERCEPT-treated plasma units have demonstrated therapeutic efficacy with an adverse event profile that is consistent with untreated plasma. Over the course of 7 years in a haemovigilance study, 4067 patients received 19 175 PCT-PLT transfusions. No case of transfusion-related acute lung injury, transfusion-associated graft-versus-host disease, transfusion-transmitted infection or death was attributed to the transfusion of INTERCEPT platelets.