Safety & Hemovigilance

Through preclinical testing, extensive clinical investigations and continuing post-marketing hemovigilance, the INTERCEPT Blood System has demonstrated high margins of safety.

Proven in Routine Use

Over 700,000 INTERCEPT-treated units have been transfused in more than 60 blood centers in 14 countries. Cerus has supported an extensive program of hemovigilance studies to monitor the introduction of INTERCEPT. More than 70,000 transfusions have been monitored in the ongoing hemovigilance program.

Compliance with Regulatory Requirements for European Approval

For both INTERCEPT Platelets and Plasma, the Medical Device Design Dossiers submitted for European approval included full Drug Dossiers to support safety and efficacy of the amotosalen component. Regulatory authorities concluded that INTERCEPT Platelets and Plasma are not clinically different from untreated products and may be prescribed and transfused in accordance with standard infusion methods.¹

Phase I Through III Clinical Trials for Controlled Study in Human Subjects

Following successful completion of the early clinical studies, multiple Phase III trials were performed to evaluate each product’s therapeutic performance and safety in patient populations requiring transfusions. Treated platelets and plasma were similar to conventional products for control of bleeding; the safety profile of treated products was not different from conventional platelets and plasma.

INTERCEPT was extensively evaluated prior to product approval to establish the safety and efficacy of both amotosalen and amotosalen-treated platelets and plasma.  Consistent with requirements for new pharmaceutical drugs, results of pre-clinical and Phase I through III clinical testing were submitted to European authorities for consideration.  Ongoing hemovigilance trials continue to evaluate the performance of the products in routine use.

Extensive Preclinical Characterization of Amotosalen and Photochemical
Treatment Process

Preclinical studies were performed using both amotosalen alone and illuminated mixtures of amotosalen, photoproducts, and platelets or plasma. Amotosalen was shown to photodegrade into well-characterized species and is rapidly excreted following transfusion.^2,3 Preclinical safety studies demonstrated high safety margins for amotosalen with no toxicologically relevant effects for either INTERCEPT Platelets or INTERCEPT Plasma.²

References:
1. Supported by approved technical documentation for INTERCEPT Platelets and INTERCEPT Plasma.
2. V Ciaravino, et al., Hum Exp Toxicol. 2001; 20: 533-50.
3. V Ciaravino, et al., Vox Sanguinis 2003; 85:171-82.

Use of INTERCEPT is contraindicated in patients with a history of allergic response to amotosalen or psoralens. No pathogen inactivation system has been shown to inactivate all pathogens.