Presentation

• Beriplex NZ is a four factor prothrombin complex concentrate, supplied as a 500 IU vial containing factors II, VII, IX, and XIX, as well as Protein C and S (see datasheet for ranges of concentrations).
• Each single pack contains one vial of product, one 20 mL vial of Water for Injections and one Mix2Vial filter transfer set.
• Beriplex NZ also contains up to 343 mg (approximately 15 mmol) sodium and up to 200 IU heparin per 100 mL reconstituted solution.

ABO Compatibility

• A blood group is not required prior to release.
• Compatibility is not relevant for manufactured (fractionated) plasma product transfusion

Storage and Reconstitution

• See the Mix2Vial System for intructions on reconsitution of the vial.
• Beriplex NZ is stored below 25°C in controlled Blood Bank conditions, and usually refrigerated at 2-8°C.
• Allow the vials to reach room temperature (up to 25°C) before reconstituting.
• Only remove the vials from the sealed box when ready to reconstitute (Beriplex NZ boxes are sealed to protect from light, product damage and tampering)
• Allow at least 10 minutes to reconstitute a vial of Beriplex NZ
• The technique for reconstituting Beriplex® products follows a similar, but slightly different sequence using the Mix2Vial system.
• Draw up reconstituted Beriplex NZ into a luer-lock syringe
• Do not dilute in saline or any other IV fluids or medications (the solution will not be stable and will precipitate)
• Once reconstituted infuse without delay as an IV bolus after completing all pre-blood checks at the bedside (including positive patient identification, product verification and the presence of signed informed consent)
• Multiple vials of the same product may be pooled together.
• For large volumes a syringe infusion pump can be used
• Do not refrigerate Beriplex NZ once it has been reconstituted.

Precautions

• Read manufacturer's instructions carefully.
• Note! Administering Beriplex NZ to patients who are not warfarinised substantially increases the risk of thromboembolism
• Always observe for turbidity / particulate material (floaters).
• Pumps use is acceptable.

Rate

• Beriplex NZ should be given as a slow IV bolus injection into a peripheral or central venous access line.
• The rate must not exceed 0.12mL/kg/minute up to a maximum of at 8mL/minute.
  • i.e. 3 IU / kg body weight/minute, up to a maximum of 210 IU /minute
• Administer without delay and within 3 hours of reconstituting (vials contain no antimicrobial additives)
• Some example weights and rates:
  
  

  Weight	Rate
  Over 65 kg	Max rate: 8mL/min (480 mL/hour) or at least 2.5 minutes per 500 IU vial
  40-65 kg	Max rate: 5ml/min (300 mL/hour)or at least 4 minutes per 500 IU vial
  Under 40 kg	Calculate at 0.12mL/kg/min or 7.2 ml/kg/hour

Dose

• Beriplex NZ for reversal of warfarin: 15-50 IU/kg in the following situations:
• INR is ≥ 1.5 with life threatening (critical organ) bleeding
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• INR is ≥ 2.0 and there is clinically significant bleeding
• INR is ≥10.0 and the patient is at high risk of bleeding
• a pre-op patient where surgery is urgent, INR > 1.5 due to warfarin
• NOTE:In patients weighing more than 100kg, the dose of Beriplex NZ should be based on a capped 100kg body weight and maximum dose of 50 IU/kg (i.e. the absolute maximum dose is 5000 IU)
• NOTE:Repeat dosing is not supported by clinical data and the product information documents the risk of thrombosis with repeat dosing . If repeat dosing is required within 14 days, please discuss this witha NZBS Transfusion Medicine Specialist (TMS)
• NOTE:INR correction is commonly reached 30 minutes after Beriplex® NZ injection. The co-administration of vitamin K usually takes effect within 4-6 hours and is used for more sustained reversal
• THANZ warfarin reversal guidelines (2024)

Rivaroxaban guidance

• There is no specific agent for the reversal of rivaroxaban in New Zealand
• In the event of emergency surgery or major bleeding, Beriplex NZ may be considered as part of the management plan

Monitoring and Traceability

• Recipients should remain under observation for 20 minutes following administration in case they experience an immediate adverse event requiring treatment.
• Ensure the swing label from every box is attached to the local transfusion record as a permanent record

Compatibility with other medicines and fluids

• Beriplex® NZ cannot be co-mixed or co-administered with any IV fluid, blood product or medication
• Reconstitute with the supplied WFI only; never dilute in saline or other IV fluids or medications
• Do flush the IV access/line with saline prior and post the injection

More Info

• THANZ warfarin reversal guidelines (2024)
• Patient Information Leaflet
• Beriplex Datasheet
• Warfarin reversal pocket guide
• Transfusion Medicine Handbook
• Idarucizamab datasheet