Safety and efficacy of intravenous immunoglobulin (Flebogamma ® 10% DIF) in patients with immune thrombocytopenic purpura.

AIM: To evaluate the safety and efficacy of 10% intravenous immunoglobulin (IVIG; Flebogamma®  10% DIF) in individuals with chronic immune thrombocytopenic purpura (ITP).

PATIENTS & METHODS: Patients aged 3-70 years, diagnosed with chronic ITP, received 1 g/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 ≤20 × 109 /l to ≥50 × 109 /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®  10% DIF administered over two consecutive days was safe and effective in adults and children with chronic ITP.