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.
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 who2,3:
Live an active, busy lifestyle
Participate in physical activities
Experience inadequate bleed control
myPKFiT for ADVATE helps enable PK-guided prophylaxis treatment1,2
myPKFiT is the first and only FDA-approved PK dosing software and patient app designed for ADVATE patients 16 years and older with a body weight of 45 kg or greater with hemophilia A.4
The process of PK testing and data analysis†1,5,6
Treatment plans based on a PK assessment1
Patients using the software’s reporting capability1,2
†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.
Real-world experience with myPKFiT for ADVATE software2,3
myPKFiT for ADVATE can be a helpful tool for developing strategies intended to improve adherence, tailor prophylaxis, and provide patient education.
In a retrospective chart view, myPKFiT was used to estimate PK profiles for 27 patients with severe hemophilia A who had not received prior PK assessments
Limitations: this report included a small number of patients, and a study with a larger sample would be needed to confirm these results
A personalized approach to prophylaxis may help patients achieve their goals
Real-world study description7
A prospective, observational case series that utilized myPKFiT to estimate PK profiles in a subset of 22 patients recruited from 3 centers in Spain, aged 16-53 years old with severe hemophilia A, without inhibitors, on prophylaxis with ADVATE. Specifically, the study looked at the impact of myPKFiT use for prophylaxis adjustment, annual bleeding rate (ABR), and annual joint bleeding rate (AJBR).
Overall effect of myPKFiT on positive results seen in this short-term case series cannot be further assessed, considering the small sample of patients for statistical analysis (n=22).
A study with a larger sample would be needed to confirm these results.
myPKFiT for healthcare professionals. myPKFiT User Manual. Version 3.3. Shire Inc; 2020.
Álvarez-Román MT, Fernandez-Bello I, de la Corte-Rodriguez H, et al. Experience of tailoring prophylaxis using factor VIII pharmacokinetic parameters estimated with myPKFiT® in patients with severe haemophilia A without inhibitors. Haemophilia. 2017;23(1):e50-e54. doi:10.1111/hae.13141
Valentino LA. Considerations in individualizing prophylaxis in patients with haemophilia A. Haemophilia. 2014;20(5):607-615. doi:10.1111/hae.12438
Takeda data on file.
Björkman S. Limited blood sampling for pharmacokinetic dose tailoring of FVIII in the prophylactic treatment of haemophilia A. Haemophilia. 2010;16(4):597-605. doi:10.1111/j.1365-2516.2009.02191.x
Lee M, Morfini M, Schulman S, Ingerslev J; and the Factor VIII/Factor IX Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. The design and analysis of pharmacokinetic studies of coagulation factors. International Society on Thrombosis and Haemostasis Website. https://cdn.ymaws.com/www.isth.org/resource/group/d4a6f49a-f4ec-450f-9e0f-7be9f0c2ab2e/official_communications/fviiipharmaco.pdf. March 21, 2001. Accessed July 20, 2018.
Mingot-Castellano ME, Parra R, Núñez R, Martorell M. Improvement in clinical outcomes and replacement factor VIII use in patients with haemophilia A after factor VIII pharmacokinetic-guided prophylaxis based on Bayesian models with myPKFiT®. Haemophilia. 2018;24(5):e338-e343. doi: 10.1111/hae.13540
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