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Intended Use: myPKFiT is not indicated for the treatment of von Willebrand disease and should not be used for patients who have developed neutralizing antibody to FVIII products. myPKFiT is Rx only. For safe and proper use of the myPKFiT software, please refer to the complete instructions for use in the User Manual
Please see the full intended use statement for myPKFiT below.
myPKFiT for ADYNOVATE helps enable PK-guided prophylaxis treatment1
myPKFiT is the first and only FDA-approved PK dosing software app designed for ADYNOVATE patients 12 years and older with a body weight of 29 kg or greater with hemophilia A.1,2
What is personalized PK-guided treatment?
PK-guided treatment utilizes a patient’s Pharmacokinetic (PK) profile to create a dosing regimen that is personalized to their lifestyle. PK characteristics may be influenced by patient specific variables such as age and body weight.1
Patients who may benefit
Personalized PK-guided treatment may benefit patients who2:
Live an active, busy lifestyle
Participate in physical activities
Experience inadequate bleed control
The process of PK testing and data analysis†1,3
Treatment plans based on a PK assessment1
Patients using the software’s reporting capability4
†Estimate a PK curve with as few as 2 measurable blood samples, compared to 9-11 as recommended by International Society on Thrombosis and Haemostasis guidelines.1,5
Learn how to use myPKFiT
Learn how myPKFiT can estimate your patients’ PK curves and more
CONTRAINDICATIONS: Prior anaphylactic reaction to ADYNOVATE, to the parent molecule (ADVATE® [Antihemophilic Factor (Recombinant)]), mouse or hamster protein, or excipients of ADYNOVATE (e.g. Tris, mannitol, trehalose, glutathione, and/or polysorbate 80).