Prothrombinex

Chemical

Human plasma derivative

Preparation

Lyophilised concentrate of human coagulation factors 

  • Sterile freeze-dried powder prepared from pooled human plasma
  • Concentrate prepared by adsorption of coagulation factors from plasma onto an ion-exchange medium followed by selective elution
  • Available as single vial containing 500IU of Factor IX, 500IU of Factor II, 500IU of Factor X, small amount of Factor VII & V
  • Excipients: 112mg sodium, 192IU heparin per vial
  • Does not contain antimicrobial preservative – must be used immediately after reconstitution
  • Storage at 2-8 degrees 
  • Protect from light
  • Shelf life 24 months

Indication

  • Prophylaxis/Treatment of bleeding in patients with single/multiple congenital deficiencies of Factor II or X
  • Reversal of warfarin anticoagulant therapy

Dose

Warfarin reversal: 15-50IU/kg depending on bleeding risk and initial INR 

MoA

Increases plasma levels of vitamin K dependent coagulation factors

AE

  • Phlebitis 
  • Anaphylaxis 
  • Vomiting, Fever, rash, urticaria, SOB
  • Thrombocytopenia 
  • Thrombosis, embolism, DIC/myocardial infarction
  • Blood borne virus transmission 
  • Contraindications: History of HITS, evidence of active thrombosis/DIC 

PK

A

NA

D

10% remain extracellular

M

NA

E

Excreted via kidneys (chiefly regulated by aldosterone), sweat & GIT loss in faeces

Author: Novia Tan