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Pharmacokinetic profile of children with haemophilia A receiving low-dose FVIII prophylaxis in Indonesia: A single centre experience.
Primacakti, Fitri; Sari, Teny T; Gatot, Djajadiman; Sjakti, Hikari A; Chozie, Novie A.
Afiliación
  • Primacakti F; Paediatric Haematology-Oncology Division, Department of Child Health, Dr. Cipto Mangunkusumo Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.
  • Sari TT; Paediatric Haematology-Oncology Division, Department of Child Health, Dr. Cipto Mangunkusumo Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.
  • Gatot D; Paediatric Haematology-Oncology Division, Department of Child Health, Dr. Cipto Mangunkusumo Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.
  • Sjakti HA; Paediatric Haematology-Oncology Division, Department of Child Health, Dr. Cipto Mangunkusumo Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.
  • Chozie NA; Paediatric Haematology-Oncology Division, Department of Child Health, Dr. Cipto Mangunkusumo Hospital, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.
Haemophilia ; 28(5): 720-725, 2022 Sep.
Article en En | MEDLINE | ID: mdl-35537097
BACKGROUND: Pharmacokinetic (PK) studies of low-dose prophylaxis (LDP) of coagulation factor VIII (FVIII) in children with severe haemophilia A (SHA) are scarce. OBJECTIVE: This study aims to investigate the PK profile of children with SHA receiving LDP of FVIII. METHODS: Paediatric patients receiving FVIII infusions (10 IU/kg twice weekly) were included. PK profiles were estimated using the Web Accessible Population Pharmacokinetic Service for Haemophilia (WAPPS-Haemo). The primary outcomes were the terminal half-life (t1/2 ), concentration-time profile, and time to reach an FVIII level of < 1%. The secondary outcome was the suggested dosing interval of FVIII prophylaxis based on the individual PK profile. RESULTS: Twenty-five patients were recruited; their mean age was 12.3 ± 3.0 years. The t1/2 differed among patients receiving LDP of FVIII twice weekly, with a median of t1/2 was 14.8 h (IQR 12.6-16). The median time to reach an FVIII level of < 1% was 73.8 h (IQR 58.8-80.3). Most patients could maintain a trough level of FVIII > 1% longer than 48 h. At 72-96 h, patients needed a second dose of FVIII infusion because the FVIII level was < 1%. The suggested dosing interval of FVIII prophylaxis ranged from daily to every 96 h, depending on the individual PK profile. CONCLUSION: Our study identified inter-individual differences in the PK parameters using LDP of FVIII twice weekly. The inter-individual results in different dosing intervals advise the timing of LDP. Estimating individual PK parameters enables the identification of the optimal prophylaxis frequency to prevent bleedings.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Hemostáticos / Hemofilia A Tipo de estudio: Prognostic_studies Límite: Adolescent / Child / Humans País/Región como asunto: Asia Idioma: En Revista: Haemophilia Asunto de la revista: HEMATOLOGIA Año: 2022 Tipo del documento: Article País de afiliación: Indonesia Pais de publicación: Reino Unido
Texto completo
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XML
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Hemostáticos / Hemofilia A Tipo de estudio: Prognostic_studies Límite: Adolescent / Child / Humans País/Región como asunto: Asia Idioma: En Revista: Haemophilia Asunto de la revista: HEMATOLOGIA Año: 2022 Tipo del documento: Article País de afiliación: Indonesia Pais de publicación: Reino Unido