How is pathogen inactivation for Octaplasma® performed? How does this improve the safety profile of Octaplasma®?
Why are fewer allergic reactions observed with Octaplasma® as compared to FP?
Pooling plasma and viral immune neutralization utilized in manufacturing of Octaplasma® reduces allergic reactions by diluting and reducing antibody titres against blood cells and plasma proteins25,26 and by eliminating the highest molecular weight forms of vWF. 27 The risk of alloimmunization or other cell-related reactions is further reduced by size-exclusion and ligand chromatography, a sterile cell filtration process used in Octaplasma® manufacturing.20,28
What are the common side effects of Octaplasma®?
In a single- center study comparing Octaplasma® to Cryosupernatant plasma (CSP) for large volume plasma exchange in acute TTP, citrate reactions decreased by >50% and allergic reactions decreased > 60% with use of Octaplasma®.23
Data from the UK between 2012-2021 showed the lowest risk of transfusion reactions for SD Plasma as compared to all other plasma products.24
Is Octaplasma® safe to be administered to pregnant women?
Although no harmful effects on mother, embryo, fetus, or child are to be expected, Octaplasma® should be used in pregnant and lactating women when benefit outweighs the potential risk.3
What is the safety and efficacy profile of Octaplasma® in children?
In the LAS 212 study,20 Octaplasma® was evaluated in 50 pediatric patients aged between 0 to 16 years in the perioperative setting. Investigators assessed overall safety in this study as ‘excellent’ for all 50 patients. No ADRs were reported including no hyper-fibrinolytic events or treatment-related thromboembolic events. Hemostatic parameters were within the expected ranges after using Octaplasma®.
In the LAS 213 study,21 the safety of Octaplasma® was evaluated in 41 patients requiring therapeutic plasma exchange (TPE) aged 2 to 20 years. No thrombotic or thromboembolic events or any other treatment-related serious adverse events were reported. Overall safety was assessed by investigators as excellent for >90% of patients 24 hours after each TPE throughout the study.
The studies support the use of Octaplasma® in managing perioperative or bleeding pediatric patients who require replacement therapy and for TPE in the plasma exchange.
What is the clinical evidence available with Octaplasma® in various clinical settings?
Are there any differences in the efficacy and safety of Octaplasma® as compared to FFP?
Octaplasma® is associated with reduced risk of pathogen transmission,7 a lower risk of TRALI1 and a lower risk of non-hemolytic transfusion reactions when compared to FFP, particularly allergic reactions and citrate reactions.18,22
Can I use a rapid infuser device to administer Octaplasma®
The recommended rate of infusion rate applies to most patients in receipt of any coagulation active plasma. Most plasma infusions are normally performed with an infusion rate of 10-20 mL/kg/hr, therefore the recommended rate is adequately rapid. If you are using a rapid infuser device, ensure the recommended rate is not exceeded and observe signs of citrate toxicity.
Why does the Octaplasma Product Monograph recommend avoiding concomitant administration of other blood products?
Concomitant administration of other blood products with plasma is a common and accepted clinical practice. Patients with multiple intravenous lines could receive blood products simultaneously as happens in trauma settings. We also know from the PROPPR trial that blood products administered within minutes of arrival using a transfusion ratio of 1:1:1 was associated with more patients achieving hemostasis and decreased hemorrhage-related deaths over the first 24 hours.
Octaplasma should NOT be mixed with other drugs/medicinal products and solutions, as inactivation and precipitation may occur. For instance, Octaplasma must not come in direct contact with calcium-containing solutions as calcium promotes clot formation by reacting with the citrate present in Octaplasma as an anticoagulant agent.
What is your recommendation for the use of a blood warmer to administer Octaplasma®?
Blood warmers are often used for rapid blood transfusion at a volume load of > 50 mL/kg/hr in hypothermic patients or for rare conditions where cold fluid delivery is problematic (e.g., cold agglutinins), as well as for massive transfusion to avoid hypothermia.
When blood warmers are used, for instance, in the case of previously thawed but refrigerated plasma, they should not bring any blood component to a temperature above the normal body temperature of +37°C, at which all the constituents of blood have their optimal quality and function. Higher temperatures may have a negative impact on the quality and efficacy of the product infused as well as the patients’ safety, e.g., with an increased coagulation time which is observed at temperatures of +40°C.
Most blood warmers have a free setting of the temperature between +37 and 41°C based on 0.5°C steps.
Octapharma does not have data regarding the use of a blood warmer device to administer Octaplasma®. Therefore, Octapharma cannot recommend the use of Octaplasma® for thawing or administration using devices that exceed +37 °C. If you are unsure about the temperature of a blood-warming device, do not use it to warm Octaplasma®.
