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Blood Transfusion

Beriplex

  • Beriplex ® (4-factor Prothrombin Complex Concentrate [PCC])


    Please see attached background document, for other paediatric indications for Beriplex specific to RCH, e.g., dosing for emergency direct oral anticoagulant: Beriplex human prothrombin complex guideline


    Beriplex ® (4-factor PCC) has replaced the previously available 3-factor concentrate Prothrombinex-VF.

    Active ingredients content per vial comparison
    Beriplex ® 500  Prothrombinex-VF 
    Factor II 400-960 IU ~ 500 IU
    Factor IX 400-620 IU 500 IU
    Factor X 440-1200 IU ~ 500 IU
    Factor VII 200-500 IU
    Protein C 300-900 IU
    Protein S 240-760 IU

    The CSL Product Information (PI) states that Beriplex is indicated for:

    • Treatment of bleeding due to acquired deficiency of the prothrombin complex coagulation factors (II, VII, IX and X).  

    • Reversal of vitamin K antagonists (e.g., warfarin) when rapid reversal required in perioperative setting or bleeding context.   
    • Treatment of vitamin K antagonist overdose

    The CSL Beriplex® PI states:

    The safety and efficacy of Beriplex® in the paediatric population has not been established in clinical studies.

    Due to the need to provide some pragmatic guidance to paediatric clinicians, the following warfarin reversal guidance is provided. 

    Beriplex®  Details  
    Additional RCH indications 
    • Emergency DOAC reversal  
    • Cardiopulmonary bypass bleeding  
    • Vitamin K deficiency bleeding of newborn  
    • Patient/family refusiing whole blood products
    Pharmacokinetics  
    • Peak plasma concentrations occur within five minutes of infusion 
    • Elimination half-life of coagulation factors: factor II - 60 hours, factor VII - 4.2 hours, factor IX - 17 hours, and factor X - 31 hours
    Contraindications  
    • Hypersensitivity to any components of the product. 
    • History of Heparin Induced Thrombocytopenia (HIT). Beriplex® contains Heparin.
    • In DIC, Beriplex® should only be considered after resolution of the consumptive state.
    Cautions  
    • Children with a history of thrombosis 
    • Prothrombotic state at increased risk of thrombosis  
    • Patients with liver disease, patients in active DIC, the presence of a CVAD and neonates
    Consent  
    • Blood transfusion consent should be sought (where possible)  
    Presentation  
    • 500 IU vials with 20 mL water for injection 
    Ordering and approval  
    • Requires Haematologist approval   
    • Prescribe via the EMR  
    Dosing  
    • Based on weight up to but not exceeding 100kg  
    • >15 kg round to the nearest vial size
    • ≤15 kg consider rounding to nearest 25 IU or 50 IU
    • Consider the clinical indication, current INR, target INR, need for re-anticoagulation and patient weight 
    Administration 
    • Reconstitute using diluent provided and according to the product instructions including Mix2Vial™  
    • If multiple vials of Beriplex® are required they may be pooled into a single infusion.   
    • Do not further dilute Beriplex®.  
    • Slow IV push, do not exceed 3 IU/kg body weight/minute, maximum 210 IU/minute, approximately 8 mL/minute. 
    • Do not mix with other medicinal products, administer via a separate IV line.
    Stability  
    • Store below 25°C 
    • Beriplex does not contain antimicrobial preservative.  
    • CSL recommends using immediately after reconstitution.   
    Monitoring 
    • INR check within 30 minutes post warfarin reversal  

    Beriplex® – warfarin reversal dosing guidance 
    Pre-treatment INR Beriplex® dose IU/kg
    Major bleeding that is critical organ or life threatening Any INR ≥1.5  or recent dose of Warfarin even if INR <1.5

    50 IU/kg

    (Maximum 5000 IU) 

    Urgent peri-operative reversal 

    Or 

    Major bleeding on warfarin 

    		 INR 2.0 – 3.9

    25 IU/kg

    (Maximum 2500 IU) 
    INR 4.0 – 6.0

    35 IU/kg

    (Maximum 3500 IU) 
    INR ≥6.0

    50 IU/kg

    (Maximum 5000 IU) 

     Where Beriplex ® is administered in the context of Warfarin reversal and major bleeding, vitamin K should be considered. 

     Vitamin K dosing for warfarin reversal  
    Type of warfarin reversal  Vitamin K dose
    Major bleeding irrespective of INR   Complete

    300 mcg/kg PO Or  

    IV (max 10 mg)