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Efficacy and safety of a new intravenous immunoglobulin 10% formulation (octagam® 10%) in patients with immune thrombocytopenia.
- Source :
-
Hematology (Amsterdam, Netherlands) [Hematology] 2010 Oct; Vol. 15 (5), pp. 351-9. - Publication Year :
- 2010
-
Abstract
- Intravenous immunoglobulin (IVIg) has an established role in the treatment of immune thrombocytopenia (ITP). The safety and efficacy of a new ready-to-use IVIg 10% formulation (octagam(®) 10%) were investigated in a prospective phase III study in 116 adult patients with ITP (platelet count ≤20×10(9)/l). Sixty-six patients had chronic ITP and 49 were newly diagnosed. Patients received octagam 10% 1 g/kg/day on two consecutive days; infusion rate was adjusted according to tolerability to a maximum of 0·12 ml/kg/minute. Eighty per cent of patients attained the primary efficacy endpoint of clinical response (platelet count ≥50×10(9)/l within 6 days of dosing). The median time to response was 2 days and the median duration of response was 12 days; mean response duration was 24·1 days. octagam 10% was well tolerated and effective in this population representative of adult patients with ITP, even at the maximum infusion rate of 0·12 ml/kg/minute, without unexpected safety issues.
- Subjects :
- Adult
Aged
Drug Administration Schedule
Female
Headache chemically induced
Heart Rate drug effects
Humans
Immunoglobulins, Intravenous adverse effects
Male
Middle Aged
Platelet Count
Prospective Studies
Purpura, Thrombocytopenic, Idiopathic blood
Treatment Outcome
Immunoglobulins, Intravenous therapeutic use
Purpura, Thrombocytopenic, Idiopathic drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1607-8454
- Volume :
- 15
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Hematology (Amsterdam, Netherlands)
- Publication Type :
- Academic Journal
- Accession number :
- 20863431
- Full Text :
- https://doi.org/10.1179/102453310X12719010991867