Study on Safety of Intravenous Immunoglobulin (IVIG) Maeketed in Thailand from antibody titers ABO and Rh blood group

Main Article Content

Kanittha Puwanarttharanuban
Witchuda Jariyapan
Suywaruth Jadukittinan

Abstract

Human normal immunoglobulin for intravenous administration (IVIG) is a plasma-derived product produced from human plasma by Cohn-fractionation technique. It is intended for non-specific passive immunity treatment. The plasma for fractionation is obtained from human blood containing mainly ABO and Rh blood group. The IVIG product may contain residual anti-A/B (antibody to ABO blood group) and anti-D (antibody to Rh blood group) that may be harmful to consumers. For safety of the product according to the European Pharmacopoeia 9.0 requirements, when analyzing the product at a protein concentration of 25 g/l, anti-A/B and anti-D titres should be less than or equal to 1:64 and less than 1:8, respectively. Six brands of IVIG products totally marketed in Thailand between 2015 and 2016 (not expired in 2017), were tested for anti-A/B and anti-D by direct haemagglutination method. The results revealed that all samples passed the test criteria and most anti-A/B and D titers were 1:4 to 1:16 and negative, respectively. In conclusion, these products were safe for consumers.

Downloads

Download data is not yet available.

Article Details

Section
รายงานการวิจัย

References

1.Hartung, H.P., Mouthon, L., Ahmed, R., Jordan, S., Laupland, K.B. & Jolles, S. (2009). Clinical applications of intravenous immunoglobulins (IVIg) beyond immunodeficiencies and neurology. Clinical & Experimental Immunology, 158(Supplement 1), 23-33.

2.คณะอนุกรรมการพัฒนาบัญชียาหลักแห่งชาติ. (2553). Human normal immunoglobulin, intravenous (IVIG). ใน คู่มือการใช้ยาอย่างสมเหตุผล ตามบัญชียาหลักแห่งชาติ บัญชี จ(2), หน้า 41-54. กรุงเทพฯ: สำนักงานประสานการพัฒนาบัญชียาหลักแห่งชาติ กองควบคุมยา สำนักงานคณะกรรมการอาหารและยา.

3.Jolles, S., Sewell, W.A.C & Misbah, S.A. Clinical uses of intravenous immunoglobulin. (2005). Clinical &Experimental Immunology, 142, 1–11.

4.Mohamed, M. Intravenous immunoglobulin-associated hemolysis: risk factor, challenges, and solutions. (2016). International Journal of Clinical Transfusion Medicine, 4, 121-131.

5.Thomas, M.J., Misbah, S.A., Chapel, H.M., Jones, M., Elrington, G. & Newsom-Davis, J. (1993). Hemolysis after high-dose intravenous Ig. Blood, 82, 3789.

6.Kahwaji, J., Barker, E., Pepkowitz, S., Klapper, E., Villicana, R., Peng, A., et al. (2009). Acute Hemolysis After High-Dose Intravenous Immunoglobulin Therapy in Highly HLA Sensitized Patients. Clinical Journal of American Society of Nephrology, 4(12), 1993-1997.

7.Duhem, C., Dicato, M.A. & Ries, F. Side-effects of intravenous immune globulins. (1994). Clinical & Experimental Immunology, 97(Supplement 1), 79-83.

8.Daw, Z., Padmore, R., Neurath, D., Cober, N., Tokessy, M., Desjardins, D., et. Al. (2008). Hemolytic transfusion reactions after administration of intravenous immune (gamma) globulin: a case series analysis. Transfusion, 48, 1598-1601.

9.Desborough, M.J., Miller, J., Thorpe, S.J., Murphy, M.F., & Misbah, S.A. (2014). Intravenous immunoglobulin-induced haemolysis: a case report and review of the literature. Transfusion Medicine, 24, 219–226.

10.Thorpe, S.J., Fox, B.J., Dolman, C.D., Lawrence, J. & Thorpe, R. (2003). Batches of intravenous immunoglobulin associated with adverse reactions in recipients contain atypically high anti-Rh D activity. Vox Sanguinis, 85, 80-84.

11.ศูนย์เฝ้าระวังความปลอดภัยด้านผลิตภัณฑ์สุขภาพ กองแผนงานและวิชาการ สำนักงานคณะกรรมการอาหารและยา. Intravenous Immunoglobulin (IVIG) กับการเกิดภาวะ autoantibody response. จดหมายข่าว HPVC safety news [ออนไลน์]. เข้าถึงเมื่อ 12 ธันวาคม 2560. จาก: https://thaihpvc. fda.moph.go.th/thaihvc/Public/News/uploads/hpvc_2_5_0_100477.pdf

12.European Directorate for the Quality of Medicines and Healthcare (EDQM). (2017). Human normal immunoglobulin for intravenous administration. In European Pharmacopoeia 9.0, page 2687-2689. Nördlingen: Druckerei C.H. Beck.

13.European Directorate for the Quality of Medicines and Healthcare (EDQM). (2017). 2.6.20 Anti-A and Anti-B haemagglutinins. In European Pharmacopoeia 9.0, page 213-214. Nördlingen: Druckerei C.H. Beck.