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Blood Transfusion

Beriplex

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


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


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

    Active ingredients content per vial comparison
    Beriplex® AU 500Ìý ±Ê°ù´Ç³Ù³ó°ù´Ç³¾²ú¾±²Ô±ð³æ-³Õ¹óÌý
    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® AUÌýis indicated for:

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

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

    The CSL Beriplex® AU PI states:

    The safety and efficacy of Beriplex® AU 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.Ìý

    Beriplex® AU ¶Ù±ð³Ù²¹¾±±ô²õÌýÌý
    Additional RCH indicationsÌý
    • Emergency DOAC reversalÌýÌý
    • Cardiopulmonary bypass bleedingÌýÌý
    • Vitamin K deficiency bleeding of newbornÌýÌý
    • Patient/family refusiing whole blood products
    ±Ê³ó²¹°ù³¾²¹³¦´Ç°ì¾±²Ô±ð³Ù¾±³¦²õÌýÌý
    • Peak plasma concentrations occur within five minutes of infusionÌý
    • Elimination half-life of coagulation factors: factor II - 60 hours, factor VII - 4.2 hours, factor IX - 17 hours, and factor X - 31 hours
    °ä´Ç²Ô³Ù°ù²¹¾±²Ô»å¾±³¦²¹³Ù¾±´Ç²Ô²õÌýÌý
    • Hypersensitivity to any components of the product.Ìý
    • History of Heparin Induced Thrombocytopenia (HIT). Beriplex® AU contains Heparin.
    • In DIC, Beriplex® AU should only be considered after resolution of the consumptive state.
    °ä²¹³Ü³Ù¾±´Ç²Ô²õÌýÌý
    • Children with a history of thrombosisÌý
    • Prothrombotic state at increased risk of thrombosis Ìý
    • Patients with liver disease, patients in active DIC, the presence of a CVAD and neonates
    °ä´Ç²Ô²õ±ð²Ô³ÙÌýÌý
    • Blood transfusion consent should be sought (where possible)ÌýÌý
    ±Ê°ù±ð²õ±ð²Ô³Ù²¹³Ù¾±´Ç²ÔÌýÌý
    • 500 IU vials with 20 mL water for injectionÌý
    Ordering and approvalÌýÌý
    • Requires Haematologist approvalÌýÌýÌý
    • Prescribe via the EMRÌýÌý
    ¶Ù´Ç²õ¾±²Ô²µÌýÌý
    • Based on weight up to but not exceeding 100kgÌýÌý
    • >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 weightÌý
    ´¡»å³¾¾±²Ô¾±²õ³Ù°ù²¹³Ù¾±´Ç²ÔÌý
    • If multiple vials of Beriplex® AU are required they may be pooled into a single infusion.ÌýÌýÌý
    • Do not further dilute Beriplex® AU.ÌýÌý
    • Slow IV push, do not exceed 3 IU/kg body weight/minute, maximum 210 IU/minute, approximately 8 mL/minute.Ìý
    • Do not mix with other medicinal products, administer via a separate IV line.
    StabilityÌýÌý
    • Store below 25°CÌý
    • Beriplex® AU does not contain antimicrobial preservative.ÌýÌý
    • CSL recommends using immediately after reconstitution.ÌýÌýÌý
    ²Ñ´Ç²Ô¾±³Ù´Ç°ù¾±²Ô²µÌý
    • INR check within 30 minutes post warfarin reversalÌýÌý

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

    50 IU/kg

    (Maximum 5000 IU)Ìý

    Urgent peri-operative reversalÌý

    °¿°ùÌý

    Major bleeding on warfarinÌý

    		 INR 2.0 – 3.9

    25 IU/kg

    (Maximum 2500 IU)Ìý
    INR 4.0 – 6.0

    35 IU/kg

    (Maximum 3500 IU)Ìý
    INR ≥6.0

    50 IU/kg

    (Maximum 5000 IU)Ìý

    ÌýWhere Beriplex® AU is administeredÌýin the context of Warfarin reversal and major bleeding, vitamin K should be considered.Ìý

    ÌýVitamin K dosing for warfarin reversalÌýÌý
    Type of warfarin reversalÌý Vitamin K dose
    Major bleeding irrespective of INRÌýÌý Complete

    300 mcg/kg PO OrÌýÌý

    IV (max 10 mg)ÌýÌý

    Ìý