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Adverse event reporting can be found at the bottom of the page

Administration and Storage Choosing ReFacto AFChoosing ReFacto AFChoosing ReFacto AFPersonalised dosing 

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Product InformationProduct InformationLaboratory StandardEfficacy & SafetyAdministration & StorageSupport & ResourcesSupport & ResourcesMaterialsVideosOrdering ReFacto AFContact Us

For ReFacto AF® (moroctocog alfa) Prescribing Information for Great Britain and Northern Ireland click here.
Adverse event reporting information can be found at the bottom of the page.

Laboratory Standard Using ReFacto AF® Laboratory Standard: why, when, and how Why should a product-specific laboratory standard be used?The use of the ReFacto AF® Laboratory Standard allows for consistent results regardless of assay type.1,2 Using a product-specific laboratory standard can reduce the discrepancies between the chromogenic and one-stage assay.2

 

When monitoring patients' factor VIII activity levels during treatment with ReFacto AF®, the use of a chromogenic substrate assay is recommended. Typically, the chromogenic assay yields results that are higher than those observed with use of the one-stage clotting assay.1
When to use the ReFacto AF® Laboratory Standard

The ReFacto AF® Laboratory Standard was created for use with the one-stage clotting assay (or the chromogenic assay), when testing plasma samples from patients receiving ReFacto AF®.1 It can be used exactly as you would use a normal (plasma-based) laboratory standard.2

How to prepare the ReFacto AF® Laboratory Standard3

There are 3 steps involved in preparing the ReFacto AF® Laboratory Standard. 

Step 1

  • Reconstitute the ReFacto AF® Laboratory Standard at room temperature using 1.0mL of sterile water.
  • After reconstitution, the vial contents should be transferred to a plastic tube with a stopper.
  • The reconstituted ReFacto AF® Laboratory Standard solution should be maintained at room temperature and then used within 2 hours.*
​​​​​​​* The reconstituted ReFacto AF® Laboratory Standard is stable for 2 hours.
Unopen vials should be stored at -20ºC.
Do not use the vial if there is a lack of vacuum when opening.


Step 2
  • The Refacto AF® Laboratory Standard should be prediluted in factor VIII-deficient (haemophilic or chemically-or-immuno-depleted) plasma containing normal functional levels of von Willebrand factor to yield a 1.0IU/mL solution.
  • The prepared standard should be used once and discarded.
  • DO NOT REFREEZE.
Step 3
  • Dilute the ReFacto AF® Laboratory Standard solution in accordance with standard operating procedures to create a standard curve for analysis of plasma samples.
  • Once the standard curve is established, analysis samples from patients treated with ReFacto AF® may begin.
  • Discard all unused materials following universal precautions.


The Refacto AF Laboratory Standard is intended as a calibrated reference in constructing standard or calibration curves for one-stage clotting or chromogenic substrate coagulation assays.3

For more information, please refer to the Laboratory Standard leaflet in the support and resources page or get in touch with the Pfizer Haemophilia team here

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Both CSA and OSA can be used for monitoring using the ReFacto AF Laboratory Standard

Product-specific reference standard use minimises OSA discrepancies


Well-established methods e.g. Bethesda assay, Nijmegen-modified Bethesda assay exist to measure FVIII inhibitors

Guidelines and expert consensus recommend ITI for inhibitor management
Click here for materials on laboratory standards
Explore More

Access data on the clinical efficacy & safety of ReFacto AF® for prophylaxis, on-demand treatment, and surgery.

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Materials 

Access resources and additional information that aim to support you and your patients.

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Contact Us 

Contact us for more information on ReFacto AF and download our FAQ for supply and stock related queries.

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References

ReFacto AF® Summary of Product Characteristics. For Great Britain, available here. For Northern Ireland,available here.Ingerslev J et al. J Thromb Haemost. 2004;2(4):632-638.Pfizer Data on File: PP-REF-GBR-0358
PP-REF-GBR-0353 July 2023

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search 

for MHRA Yellow Card in Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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