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PATIENT SAFETY



Plasma exchange is known to be safe and well-tolerated, with the majority of reactions and complications being mild, easily treated, and of limited duration.1




Profile of Adverse Events (AEs)

The World Apheresis Association registry data update of over 15,000 centrifugal apheresis procedures reported that 93.9 percent of patients did not experience any AEs. Of the 6.1 percent of patients that did experience AEs, the type and severity of reactions are detailed below:2

1.6% Mild (Tolerated without medication)

3.8% Moderate (Needed medication due to AE)

0.7% Severe (Interrupted due to AE)






Would you like to educate your patients about plasma exchange?



Apheresis-Related Safety Information

    Contraindications

    Leukocytapheresis is contraindicated in acute myeloid leukemia FAB M3 (acute promyelocytic leukemia) because of the accompanying disseminated intravascular coagulation.3,4 Other contraindications for the use of the Spectra Optia system are limited to those associated with the infusion of solutions and replacement fluids as required by the apheresis procedure and those associated with all types of automated apheresis systems.

    Adverse events of apheresis procedures can include

    Anxiety, headache, light-headedness, digital and/or facial paresthesia, fever, chills, hematoma, hyperventilation, nausea and vomiting, syncope (fainting), urticaria, hypotension, allergic reactions, infection, hemolysis, thrombosis in patient and device, hypocalcemia, hypokalemia, thrombocytopenia, hypoalbuminemia, anemia, coagulopathy, fatigue, hypomagnesemia, hypogammaglobulinemia, adverse tissue reaction, device failure/disposable set failure, air embolism, blood loss/anemia, electrical shock, fluid imbalance and inadequate separation of blood components.

    Reactions to blood products transfused during procedures can include

    Hemolytic transfusion reaction, immune-mediated platelet destruction, fever, allergic reactions, anaphylaxis, transfusion-related acute lung injury (TRALI), alloimmunization, posttransfusion purpura (PTP), transfusion-associated graft-versus-host disease (TA-GVHD), circulatory overload, hypothermia, metabolic complications and transmission of infectious diseases and bacteria.5,6

    Restricted to prescription use only
    • Operators must be familiar with the system's operating instructions.
    • Procedures must be performed by qualified medical personnel.









1Winters J. Plasma exchange: Concepts, mechanisms, and an overview of the American Society for Apheresis Guidelines. Hematology Am Soc Hematol Educ Program. 2012:7-12.

2Mortzell Henriksson M, Newman E, Witt V, et al. Adverse events in apheresis: An update of the WAA registry data. Transfus Apher Sci. 2016;54(1):2-15.

3Vahdat L, Maslak P, Miller WH Jr, et al. Early mortality and the retinoic acid syndrome in acute promyelocytic leukemia: impact of leukocytosis, low-dose chemotherapy, PMN/RAR-alpha isoform and CD13 expression in patients treated with all-trans retinoic acid. Blood. 1994;84(11):3843-3849.

4Daver N, Kantarjian H, Marcucci G, et al. Clinical characteristics and outcomes in patients with acute promyelotic leukaemia and hyperleucocytosis. Br J Haematol. 2015;168(5):646-653.

5AABB. Circular of Information for the Use of Human Blood and Blood Components. Bethesda, MD: AABB; 2017.

6European Directorate for the Quality of Medicines & HealthCare (EDQM). Guide to the Preparation, Use and Quality Assurance of Blood Components. 1. 19th edition. Strasbourg, France: EDQM Council of Europe; 2017.






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