Safety And Efficacy Of Intravenous Immunoglobulin (Flebogamma((R)) 10% Dif) In Patients With Immune Thrombocytopenic Purpura
IMMUNOTHERAPY(2019)
Abstract
Aim: To evaluate the safety and efficacy of 10% intravenous immunoglobulin (IVIG; Flebogamma((R))10% DIF) in individuals with chronic immune thrombocytopenic purpura (ITP). Patients & methods: Patients aged 3-70 years, diagnosed with chronic ITP, received 1g/kg IVIG over two consecutive days. Results:64 evaluable patients (51 adults, 13 children) with chronic ITP received IVIG. The primary efficacy end point (increased platelet counts from 20x10(9)/l to 50x10(9)/l by day 8) was achieved by 81.3% of patients; mean time to response was 1.7 days (all responders). Adverse events, mostly mild or moderate, were reported in 59 patients (92.2%). Conclusion: Flebogamma((R))10% DIF administered over two consecutive days was safe and effective in adults and children with chronic ITP.
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Key words
Flebogamma DIF,hemorrhage,immune thrombocytopenic purpura,intravenous immunoglobulin,ITP
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