OCTAPLASLG Solution for infusion Ref.[27958] Active ingredients: Human plasma protein fraction

Pharmacotherapeutic group: Blood substitutes and plasma protein fractions,
ATC code: B05AA

The content and distribution of plasma proteins in octaplasLG remain in the final product at comparable levels to those in the raw material FFP, i.e. 45-70 mg/mL, and the major plasma proteins are all within the reference ranges for healthy blood donors (see table 2). Out of a mean total protein content of 58 mg/ml, albumin accounts for 50% (29 mg/ml), whereas the immunoglobulin classes G, A, and M are present at levels of 8.1, 1.6, and 0.8 mg/ml, respectively. As a result of the S/D treatment and purification, the content in lipids and lipoproteins is reduced. This is of no relevance within the indications for octaplasLG.

The manufacturing process levels out inter-donor variations and maintain the plasma proteins in a functional state. Therefore, octaplasLG possesses the same clinical activity as the average single-donor FFP unit, but is more standardised. The finished product is tested for coagulation factors V, VIII, and XI, and the inhibitors protein C, protein S, and plasmin inhibitor. A minimum of 0.5 IU/mL is obtained for each of the three coagulation factors, whereas the inhibitor levels are guaranteed equal or higher than 0.7, 0.3, and 0.2 IU/mL. The fibrinogen content is between 1.5 and 4.0 mg/mL. In routine production, all clinically important parameters are within the 2.5-97.5 percentiles reference range for single-donor FFP, except plasmin inhibitor (also known as α2-antiplasmin) that is just below (see table 2). octaplasLG displays the same von Willebrand factor multimeric pattern as normal plasma.

Table 2. Global coagulation parameters and specific coagulation factors and inhibitors in octaplasLG:

^* According [1,2] based on the testing of 100 healthy blood donors and defined by the 2.5 and 97.5 percentiles; or ^** according package insert of test kit.
^# A disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13. Also known as von Willebrand factor-cleaving protease (VWFCP).
^## Also known as α2-antiplasmin.

Clinical studies

An open-label, multicentre, post-marketing study investigated the safety, tolerability, and efficacy of octaplasLG in 37 neonates/infants (0 to 2 years old), and 13 children and adolescents (>2 to 16 years old). Forty patients had cardiac surgery, 5 an orthotopic liver transplant, and 5 required replacement of multiple coagulation factors (4 of these patients had sepsis). In the 28 patients who had bypass priming (all aged ≤2 years), the mean dose was 20.2 mL/kg. In 20 other patients, the mean dose of the first infusion was 16.5 mL/kg in those aged ≤2 years and 12.7 mL/kg in those aged >2 years. There were no hyperfibrinolytic events or thromboembolic events reported that were judged to be related to treatment with octaplasLG. Results of the haemostatic tests performed following infusions of octaplasLG were within the ranges expected by the investigators for patients requiring plasma infusions for bleeding indications.

¹ Hellstern P, Sachse H, Schwinn H, Oberfrank K. Manufacture and characterization of a solvent/detergent-treated human plasma. Vox Sang 1992; 63:178-185

² Beeck H, Hellstern P. In vitro characterization of solvent/detergent-treated human plasma and of quarantine fresh frozen plasma. Vox Sang 1998; 74 (Suppl. I):219-223