Octaplex Composition: Per-Millilitre Concentrations
Octaplex is a four-factor prothrombin complex concentrate containing therapeutic amounts of coagulation factors II, VII, IX, and X, with dosing standardized to factor IX content at approximately 25 IU/mL after reconstitution.
Core Clotting Factor Content
Factor IX serves as the reference standard for all 4-factor PCC products, with dosing expressed in international units (IU) of factor IX, where one IU represents the activity of factor IX in 1 mL of normal plasma 1
Octaplex contains proportional amounts of all four vitamin K-dependent factors (II, VII, IX, X), with the concentration of factors II and X approximately equivalent to factor IX content 2, 3
Factor VII concentration is present in therapeutic amounts, which distinguishes 4-factor PCCs like Octaplex from 3-factor formulations that contain minimal or no factor VII 4, 2
The typical reconstitution yields approximately 20-25 IU/mL of factor IX activity, meaning a 500 IU vial reconstitutes to approximately 20-25 mL total volume 2
Anticoagulant Proteins and Additives
Proteins C and S are included in variable amounts as natural anticoagulant proteins to help balance the prothrombotic potential of the concentrate 5, 1
Small amounts of heparin are incorporated into the formulation to reduce thrombotic risk during administration 5, 1
Some formulations may contain antithrombin as an additional safeguard against thrombosis, though this varies between PCC products 1, 3
Product Characteristics
Octaplex is supplied as lyophilized powder that requires reconstitution at room temperature before use, allowing for rapid preparation in emergency situations 5, 2
The concentrate provides approximately 25-fold higher concentration of vitamin K-dependent clotting factors per unit volume compared to fresh frozen plasma 5
Viral safety is ensured through pathogen reduction and inactivation processes during manufacturing 5
Biochemical Variability
Significant differences exist between commercial PCC products in terms of coagulation inhibitor capacity, purity, and exact factor ratios, even among 4-factor formulations 3
Batch-to-batch variability may occur within the same brand, which can be clinically relevant for patients requiring frequent infusions 5
Octaplex showed no detectable activated coagulation factors in biochemical comparison studies, confirming product safety regarding thrombotic activation 3
Clinical Dosing Context
Standard clinical dosing is weight-based using factor IX units per kilogram (e.g., 25-50 IU/kg depending on INR), not per-millilitre concentrations, because the reconstituted volume varies by vial size 5, 1
A typical 500 IU vial reconstitutes to approximately 20 mL, yielding roughly 25 IU/mL, though practitioners should always verify the specific product insert for exact reconstitution volumes 2