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