Be ready. The INTERCEPT Blood System for Platelets and Plasma pathogen reduction system

Transcription

1 Be ready. The INTERCEPT Blood System for Platelets and Plasma pathogen reduction system

2 INTERCEPT Blood System for Platelets an Blood safety is changing Safe donated blood is critical to improving certain patient outcomes. Current testing measures have greatly improved blood safety, particularly with regard to established transfusion-transmitted infections (TTIs) such as HIV, HBV, and HCV. Yet residual risks exist such as those due to emerging pathogens 1,2 and bacterial contamination. 3-6 Examples of recent emerging pathogens are chikungunya and dengue, pathogens for which there are no commercially available tests. Bacterial contamination has also been reported as posing significant TTI risk with an estimated contamination rate of 1 in every 1,500 platelet units. 3-6 Continued minimization of such risks help ensure the safety of the blood supply. The INTERCEPT Blood System for Platelets and Plasma Pathogen reduction is recognized by AABB 7-9 and FDA 10,11 as an effective strategy to reduce the risk of transfusion transmitted infections (TTI) and potentially reduce the risk of transfusion-associated graft versus host disease (TA-GVHD). Be ready.

3 d Plasma, pathogen reduction system The INTERCEPT Blood System- Join the movement toward proactive blood safety For CONTRAINDICATIONS, WARNINGS, and REFERENCES, see fold-out back cover. See package insert for full prescribing information.

4 Robust, broad INTERCEPT Blood System for Platele proactively help keep the blood sup Proven safe and effective INTERCEPT Blood System processed platelets ( INTERCEPT Platelets ) and plasma ( INTERCEPT Plasma ) demonstrate safety and therapeutic efficacy as supported by several clinical trials and hemovigilance programs. INTERCEPT Platelets Evaluated in numerous clinical trials in which over 1000 subjects received INTERCEPT Platelets Shown safe in routine use through hemovigilance programs covering >300,000 INTERCEPT-processed platelet components Demonstrated prevention of septic transfusion reactions due to bacterial contamination when using INTERCEPT Platelets in routine settings The INTERCEPT Blood System has been used in Europe for over ten years INTERCEPT Plasma Evaluated in eight clinical studies, involving over 600 patients requiring plasma transfusion Routine use in over 100 centers in Shown safe in routine use through hemovigilance programs covering over 200,000 INTERCEPT-processed plasma components.21,27,28 Kits sold to produce over Demonstrated effective retention of coagulation factors as shown through an in vitro study in which functional activity of plasma proteins were evaluated countries 3,500,000 transfusable units

5 spectrum pathogen reduction ts and Plasma, pathogen reduction system brings US blood centers a means to ply safe with broad spectrum protection against transfusion-associated pathogens. A proactive approach to reducing the risk of transfusion-transmitted infections* The INTERCEPT Blood System for Platelets and the INTERCEPT Blood System for Plasma are the first FDA-approved pathogen reduction systems for use by blood establishments intended to reduce the risk of TTI. 10,29 A broad spectrum of viruses, gram-positive and gram-negative bacteria, spirochetes, parasites and leukocytes are inactivated with INTERCEPT pathogen reduction. Robust inactivation is achieved with a 4 log reduction for most pathogens. Examples include established agents such as HIV, HBV**, HCV** and WNV, as well as emerging infectious agents, such as chikungunya, Babesia, and Plasmodium parasites. 10,29 INTERCEPT Platelets INTERCEPT Plasma Approved for use with apheresis platelets, the INTERCEPT Blood System for Platelets reduces the risk of microbial contamination in blood components, thus reducing TTI and sepsis risk. The INTERCEPT process also reduces the number of T-cells to a level that potentially lowers the risk of transfusion-associated graft-versus-host disease (TA-GVHD). 10 The INTERCEPT Blood System is approved for use with whole blood-derived or apheresis plasma. 29 Clincial trials have supported the use of INTERCEPT Plasma in different clinical settings, such as for acquired clotting disorders associated with liver disease and Thrombotic Thrombocytopenic Purpura (TTP) *Certain non-enveloped viruses (e.g., HAV, HEV, B19 and poliovirus) and Bacillus cereus spores have demonstrated resistance to the INTERCEPT process. **Pathogen reduction demonstrated for DHBV and BVDV, model viruses for HBV and HCV, respectively. For CONTRAINDICATIONS, WARNINGS, and REFERENCES, see fold-out back cover. See package insert for full prescribing information.

6 Achieve operational gains with the INTERCEPT Blood System

7 INTERCEPT Blood System for Platelets and Plasma, pathogen reduction system Operational Efficiency Pathogen reduction provides ways in which to streamline blood center operations. Furthermore, implementation of the INTERCEPT Blood System for Platelets and Plasma ( The INTERCEPT System ) is straightforward and easy with Cerus experienced deployment team. The INTERCEPT System offers: The ability to avoid or replace bacterial testing INTERCEPT offers the potential to replace bacterial detection methods, including point of issue testing, with its ability to reduce the risk of bacterial contamination of platelets and sepsis. 4,8 Increased flexibility with early platelet release Unlike bacterial culture, INTERCEPT treatment allows for immediate accessibly of platelet units. This provides added flexibility for managing inventory, and enables hospitals to obtain fresher platelets. Two platelet doses from one kit Blood centers are able to produce two therapeutic platelet doses from a single INTERCEPT Dual Storage Processing Set, leading to decreased kit costs. 10 Three plasma doses from one kit Blood centers are able to pool two whole-blood derived plasma units to produce three-200 ml dose INTERCEPT Blood System processed plasma units. 29 Easy implementation Cerus brings a seasoned deployment team to help blood centers transition smoothly to pathogen reduction. With over ten years of experience in blood center operations, Cerus deployment team is ready with tested techniques and in-depth training to help centers adopt INTERCEPT. One pathogen reduction platform Pathogen reduction is simplified through the use of the same illumination device and process for platelets and plasma. 10,29 For CONTRAINDICATIONS, WARNINGS, and REFERENCES, see fold-out back cover. See package insert for full prescribing information.

8 INTERCEPT Blood System for Platelets and Plasma, pathogen reduction system CONTRAINDICATIONS Contraindicated for preparation of plasma or platelet components intended for patients with a history of hypersensitivity reaction to amotosalen or other psoralens. Contraindicated for preparation of plasma or platelet components intended for neonatal patients treated with phototherapy devices that emit a peak energy wavelength less than 425 nm, or have a lower bound of the emission bandwidth <375 nm, due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen. WARNINGS AND PRECAUTIONS Only INTERCEPT Processing Sets for plasma or platelets are approved for use in the INTERCEPT Blood System. Use only the INT100 Illuminator for UVA illumination of amotosalen-treated plasma or platelet components. No other source of UVA light may be used. Please refer to the Operator s Manual for the INT100 Illuminator. Discard any plasma or platelet components not exposed to the complete INT100 illumination process. Tubing components and container ports of the INTERCEPT Blood System for Plasma or Platelets contain polyvinyl chloride (PVC). Di(2-ethylhexyl)phthalate (DEHP) is known to be released from PVC medical devices, and increased leaching can occur with extended storage or increased surface area contact. Blood components will be in contact with PVC for a brief period of time (approx. 15 minutes) during processing. The risks associated with DEHP released into the blood components must be weighed against the benefits of therapeutic transfusion. PLATELETS PLASMA Pulmonary events: Acute Respiratory Distress Syndrome (ARDS) INTERCEPT processed platelets may cause the following adverse reaction: Acute Respiratory Distress Syndrome (ARDS). An increased incidence of ARDS was reported in a randomized trial for recipients of INTERCEPT processed platelets, 5/318 (1.6%), compared to recipients of conventional platelet components (0/327). Monitor patients for signs and symptoms of ARDS. Amotosalen-treated plasma may cause the following adverse reaction: Cardiac Events In a randomized controlled trial of therapeutic plasma exchange (TPE) for TTP, five patients treated with INTERCEPT Blood System processed plasma and none with conventional plasma had adverse events in the cardiac system organ class (SOC) reported. These events included angina pectoris (n=3), cardiac arrest (n=1), bradycardia (n=1), tachycardia (n=1) and sinus arrhythmia (n=1). None of these events resulted in documented myocardial infarction or death. Monitor patients for signs and symptoms of cardiac events during TPE for TTP.

9 INTERCEPT Blood System for Platelets and Plasma pathogen reduction system References 1. Stramer SL,et al. Transfusion 2009;49(Suppl 2):1S-29S. 2. Dodd RY. Practical transfusion medicine. 4th ed. Chichester: Wiley; p Murphy WG, et al. Vox Sang 2008;95: Dumont LJ, et al. Transfusion 2010;50: Jacobs MR et al. Transfusion 2011;51: Pearce S, et al. Transfus Med 2011;21: Standards for Blood Banks and Transfusion Services, AABB, 30th edition, AABB Weekly Report, January 15, INTERCEPT Blood System for Platelets Dual Storage (DS) Processing Set Package Insert, March 15, Department of Health and Human Services, Food and Drug Administration (FDA); Requirements for Blood and Blood Components Intended for Transfusion for Further Manufacturing Use; Final Rule; Federal Register; Vol. 80, No. 99; May 22, 2015;Rules and Regulations. 12. Snyder E, et al. Transfusion 2004;44: Corash, L, et al. Transfusion 2000;40(S10): Slichter SJ, et al. Transfusion 2006;46: McCullough J, et al. Blood 2004;104(5): Janetzko K, et al. Transfusion 2005;45(9): van Rhenen DJ, et al. Blood 2003;101: Schlenke P, et al. Ann Hematol 2011;90(12): Infanti L, et al. Transfus Apher Sci 2011;45(2): Sweeney J, Lozano M. Platelet Transfusion Therapy. Bethesda: AABB Press, French National Agency for Medicine and Health Product Safety/ANSM, Hemovigilance Activity Reports, SwissMedic Haemovigilance Annual Reports, Hambleton J et al. Transfusion 2002;42: de Alarcon P et al. Transfusion 2005;45: Mintz PD et al. Blood 2006;107: Mintz PD et al. Transfusion 2006;46: Cazenave JP et al. Transfusion 2010;50: Bost V et al. Vox Sanguinis 2013;104: INTERCEPT Blood System for Plasma Package Insert, Cerus Corporation; Aug. 17, Schmidt MS, et al. Vox Sang 2011;101(S1): Nussbaumer W et al. Transfusion 2007;47(7): Lin L, et al. Transfusion 2004;44:

10 2016 Cerus Corporation. Cerus, INTERCEPT Blood System and INTERCEPT are registered trademarks of Cerus Corporation. MKT-EN v3.0 Choose the INTERCEPT Blood System for Platelets and Plasma, pathogen reduction system The INTERCEPT Blood System for Platelets and the INTERCEPT Blood System for Plasma enable blood centers to reduce transfusion transmitted infectious risk while providing therapeutically effective platelets and plasma to patients. Are you ready? Contact Cerus today. GLOBAL HEADQUARTERS 2550 Stanwell Drive Concord, CA US Rx only. There is no pathogen reduction process that has been shown to eliminate all pathogens. Certain non-enveloped viruses (e.g., HAV, HEV, B19 and poliovirus) and Bacillus cereus spores have demonstrated resistance to the INTERCEPT process. For CONTRAINDICATIONS, WARNINGS, and REFERENCES, see fold-out back cover. See package insert for full prescribing information.