What is the dose of Octaplex (Prothrombin Complex Concentrate) in a 100 mL solution?

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Octaplex Concentration in 100 mL Solution

Octaplex is supplied as a powder for reconstitution, and when reconstituted with 100 mL of solvent, it contains 500 IU of Factor IX activity per 100 mL (equivalent to 5 IU/mL). 1, 2

Standard Vial Configurations

  • Octaplex vials contain 500 IU of Factor IX when reconstituted with the accompanying 100 mL of solvent, resulting in a concentration of 5 IU Factor IX per mL 1, 3

  • The product is a four-factor prothrombin complex concentrate containing balanced amounts of vitamin K-dependent coagulation factors (Factors II, VII, IX, and X) in physiological ratios 4

Clinical Dosing Context

  • For warfarin reversal, Octaplex is typically dosed at 25-50 IU/kg body weight based on INR levels:

    • 25 IU/kg if INR is 2-4.0 5
    • 35 IU/kg if INR is 4-6.0 5
    • 50 IU/kg if INR is >6.0 5
  • For direct Factor Xa inhibitor reversal, a fixed dose of 2,000 units (400 mL of reconstituted solution) is reasonable for severe or life-threatening bleeding 5

  • Studies have used doses ranging from 15-83 IU/kg body weight, with median doses of 20-41 IU/kg showing effective INR correction 1, 2, 4

Volume Calculations

  • A 1,000 IU dose requires 200 mL of reconstituted Octaplex solution 3

  • For a 70 kg patient requiring 35 IU/kg (2,450 IU total), approximately 490 mL of reconstituted solution would be needed 5

  • The 40 mL standard dose used in some protocols delivers approximately 200 IU Factor IX 3

Administration Characteristics

  • Onset of action occurs within 10 minutes of intravenous administration, with INR correction typically achieved within 1 hour 1, 4

  • Single dose administration is sufficient in 95% of cases for effective reversal 2

  • The product can be administered via intraosseous route if intravenous access is difficult 5

References

Research

Prothrombin complex concentrate (Octaplex): a Portuguese experience in 1152 patients.

Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis, 2012

Research

Prothrombin complex concentrate for the urgent reversal of warfarin. Assessment of a standard dosing protocol.

Transfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis, 2012

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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