Multicenter Pharmacokinetic Evaluation Of Rfviii-Fc (Elocta) In A Real Life And Comparison With Non-Extended Half-Life Fviii Concentrates

BLOOD(2018)

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摘要
Background: The use of extending half-life (EHL) FVIII or FIX products is today a current strategy in Hemophilia A (HA) patients for improving prophylaxis and reducing the number of IV injections. Fc fusion technology is based on the use of the neonatal Fc receptor and endogenous Fc recycling pathway, thereby prolonging the half-life (T1/2) of rFVIII-Fc. A single dose phase 1/2 pharmacokinetic (PK) study performed in 16 severe HA patients demonstrated a prolonged T ½ of rFVIII-Fc equal to 18.8 hours (mean) compared to 12.2 hours with one conventional rFVIII (Malhangu et al. Blood 2014).
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关键词
multicenter pharmacokinetic evaluation,elocta,non-extended,half-life
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