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myPKFiT™ for ADVATE

myPKFiT™ for ADVATE®

The first and only FDA-cleared PK dosing software for patients 16 and over with hemophilia A

The myPKFiT software is intended for use by licensed healthcare professionals (HCPs) who are familiar with hemophilia care. The myPKFiT software can be used to generate ADVATE dosage amount and frequency recommendations for routine prophylaxis for an individual patient 16 years of age and older and body weight of 45 kg or greater, using that patient’s age and body weight information and local laboratory FVIII one-stage clotting activity measurements of sparse samples collected from that patient.

A minimum of two sparse sampling points are required at the recommended 3-4 hours (± 30 minutes) and at 24-32 hours (±1 hour) post-infusion.

HCPs will also be able to evaluate various prophylaxis dose regimens tailored to an individual patient’s needs and treatment plan.

The software output may be used to guide decisions on appropriate ADVATE dose and infusion intervals to maintain FVIII activity levels at or above a user specified minimum FVIII activity level between 1% to 3% above natural baseline for an individual patient in accordance with the FDA -approved dosing recommendations provided in the ADVATE Prescribing Information (PI).

myPKFiT should only be used to evaluate prophylactic dosing regimens for hemophilia A patients treated with ADVATE, as per the ADVATE Prescribing Information (PI).

myPKFiT for ADVATE is not indicated for the treatment of von Willebrand disease. myPKFiT for ADVATE should not be used for patients who have developed neutralizing antibody (inhibitor) to FVIII products.

myPKFiT for ADVATE is Rx Only. For safe and proper use of the myPKFiT software, please refer to the complete instructions for use in the User Manual.

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S36724 02/18

Help your patients prevent bleeds with prophylaxis1

  • Extensively studied, with evidence spanning over a decade from 12 prospective studies2‑7
  • Only ADVATE® [Antihemophilic Factor (Recombinant)] has 13 years of experience in the real world as a third-generation plasma/albumin-free recombinant factor VIII8
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