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    Home > Active Ingredient News > Blood System > Experience Sharing of the Latest Approved PK Software from Other Stones (4): Experience in Turkey

    Experience Sharing of the Latest Approved PK Software from Other Stones (4): Experience in Turkey

    • Last Update: 2021-10-01
    • Source: Internet
    • Author: User
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    In order to calculate PK parameters more conveniently and quickly, Takeda has developed a pharmacokinetic (PK)-guided hemophilia A management tool (recombinant human coagulation factor VIII dose calculation software for injection, hereinafter referred to as "PK software")
    .

    This tool has been approved by the National Medical Products Administration (NMPA) and is suitable for patients with hemophilia A who are 16 years of age and older (weight 45kg and above) who are treated with recombinant human coagulation factor VIII (rAHF-PFM) for injection 1
    .

    The newly approved PK software estimates individual PK parameters based on FVIII laboratory data and personal information, and calculates preventive treatment doses (that is, regular replacement treatment doses) based on these parameters, for use by healthcare professionals (HCP)2
    .

    In this issue, let's take a look at the clinical use from Turkey
    .

    Turkey experience sharing-PK software clinical use background PK software application 1 The PK software can generate rAHF-PFM by performing FVIII phase I coagulation activity measurements on sparse samples of the patient based on information such as the age and weight of the individual patient and the local laboratory Dosing regimen is recommended
    .

    HCP can formulate individualized preventive treatment plans based on software prediction results, individual patient needs and treatment plans
    .

    Advantages and convenience of the PK software: Compared with the 11 samples in the standard PK sampling, the PK software only uses 2 blood samples to calculate the individualized treatment dosage1
    .

    Assist in the formulation of individualized preventive treatment plans: PK-guided individualized treatment based on PK software can significantly reduce bleeding and improve the quality of life of patients3; the use of PK software increases the number of patients undergoing PK research (patients have no previous PK data ), and provide a basis for the formulation of individualized preventive treatment plans4
    .

    Turkey experience sharing-PK software clinical use study design 5 The study included 135 patients with hemophilia receiving rAHF-PFM preventive treatment from 28 centers, of which 29 patients received primary preventive treatment and 106 patients received secondary preventive treatment
    .

    All patients used PK software for PK analysis
    .

    The treatment plan was adjusted according to the patient's PK outcome, joint status, physical activity level, and bleeding phenotype
    .

    The patient's clinical history data was used to detect and evaluate the ABR before and after the adjustment of the treatment plan
    .

    The specific research design is shown in Figure 1: Figure 1 Turkey PK software use experience sharing Study design Turkey experience sharing-PK software clinical use outcome 5 Treatment profile before adjustment of preventive treatment plan All patients received rAHF 1-3 days a week -PFM preventive treatment, the therapeutic dose is 25.
    9±6.
    8 IU/kg
    .

    When the patients received rAHF-PFM prophylactic treatment at a dose of 25.
    7±7.
    3 IU/kg, all patients were subjected to PK determination
    .

    The patient's half-life is 10.
    0±1.
    9 (6.
    0-17.
    8) h, and the time required for the FVIII level to reach <1% is 51.
    1±11.
    3 (27.
    0-110.
    0) h
    .

    Overview of the adjustment of the preventive treatment plan assisted by PK software After the PK evaluation assisted by the PK software, the preventive treatment plan of 51 patients (38%) was re-adjusted.
    The specific adjustment of the plan is shown in Figure 2: Figure 2 Patient preventive treatment Program adjustments PK software-assisted preventive treatment can reduce bleeding Compared with preventive treatment without PK software-assisted, the annual bleeding rate (ABR) of patients after PK software assistance is reduced [6.
    0±4.
    2(0-36.
    0) vs 1.
    4±1.
    6 (0-5.
    0); P=0.
    025] (Figure 3) Figure 3 Comparison of bleeding after adjusting the treatment plan with PK software and using PK software to adjust the treatment plan.
    Summary According to Turkish experience, PK-guided preventive treatment The dose can be adjusted according to the estimated FVIII level during treatment
    .

    PK software only needs 2 samples to estimate PK parameters, which can be used in routine clinical practice
    .

    The use of PK software did not cause any inconvenience to patients and medical staff
    .

    For patients with hemophilia A, PK-guided individualized preventive treatment is an effective choice for reducing bleeding
    .

    References: 1.
    https:// 2.
    Instructions for use of the software for dose calculation of recombinant human coagulation factor VIII for injection.
    Revised 3.
    03 in December 2020.
    Pasca S,et al.
    Thromb.
    Res.
    2017 Sep; 1574.
    Álvarez-Román MT, et al.
    Haemophilia 2017 Jan; 23(1) 5.
    C.
    Balkan, et al.
    12th Annual Congress of the European Association for Haemophilia and Allied Disorders, 2019; Abstracts P055 approval number: VV-MEDMAT -52451 Approval Date: 9/15/2021 Expiration Date: 9/15/2023 Statement This information is intended to help medical and health professionals better understand the latest developments in the field of related diseases
    .

    The content of the information published by this site does not mean that it agrees with its description and opinions, but only provides more information
    .

    If copyright issues are involved, please contact us, and we will deal with it as soon as possible
    .

    Only for medical and health professionals to understand the information
    .

    Such information cannot replace professional medical guidance in any way, nor should it be regarded as diagnosis and treatment advice
    .

    If such information is used for purposes other than understanding the information, this site and the author shall not bear related responsibilities
    .

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