Click here for ReFacto AF® (moroctocog alfa) Prescribing Information. Adverse event reporting information can be found at the bottom of the page.
Using a product specific laboratory standard can correct the discrepancies between the chromogenic and one-stage assay.1 The use of the ReFacto AF Laboratory Standard allows for consistent results regardless of assay type.
When monitoring patients' factor VIII activity levels during treatment with ReFacto AF, the use of a chromogenic substrate assay is recommended.2 The chromogenic assay yields results that are higher than those observed with use of the one-stage clotting assay.2
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. It can be used exactly as you would use a normal (plasma-based) laboratory standard.
There are 3 steps involved in preparing the ReFacto AF Laboratory Standard
*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
The standard is to be used to measure ReFacto AF levels and is not to be used for performing diagnostic FVIII tests. It should NOT be administered to patients. It is not intended for testing patients with normal levels of FVIII:C or patients receiving other FVIII concentrates other than ReFacto AF.
We have put all of this information into a PDF format that can be downloaded for your reference.
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