What are the protein S and plasmin inhibitor levels in Octaplasma® and what is the resulting clinical implication?
December 6, 2024
|By WP Admin
A: Protein S and Plasmin inhibitor levels have been found to be below the range for normal human plasma but within the final product release limits of ≥ 0.4 IU/ml and ≥ 0.2 IU/ml, respectively, and in line with the European Pharmacopoeia (Ph. Eur.) regulations.11,12
There is no impact on the clinical efficacy of the product.13,14 However, appropriate protection against thromboembolism should be employed when S/D treated plasma is used for large volume exchange, and patients should be monitored for thromboembolic events.3
The decrease in alpha2-antiplasmin concentration may lead to elevated fibrinolysis. Accordingly, Octaplasma® should not be used to correct hyperfibrinolysis caused by a deficiency of the plasmin inhibitor.3
