Pharmacovigilance study of a regional intravenous immunoglobulin (II): evaluation and comparison of an improved pharmaceutical form.
BACKGROUND
Intravenous immunoglobulin (IVIG) therapy is an effective treatment in patients with different diseases. This product must comply with all the regulatory requirements established by the World Health Organization and the European Pharmacopoeia for clinical tolerance, therapeutic efficacy, and viral safety. Although IVIG are effective and safe products, in some patients they may cause adverse reactions.


OBJECTIVE
The aim of this study was to assess the clinical tolerance of two pharmaceutical forms (lyophilized and liquid) of Imunoglobulina G Endovenosa UNC (IVIG UNC), a regional IVIG preparation, and to compare the reported data.


METHODS
The pharmacovigilance reports of 149 infusions in 51 patients treated with lyophilized IVIG UNC and of 157 infusions in 53 patients treated with liquid IVIG UNC were statistically evaluated. Clinical tolerance was evaluated through the adverse reactions reported.


RESULTS
Lyophilized IVIG UNC: adverse reactions were reported in 6.7 % of the total number of infusions. Of these reactions, 4.0 % were mild, 2.0 % were moderate, and 0.7 % severe. Liquid IVIG UNC: adverse reactions were reported in 3.2 % of the total number of infusions; of these, 1.3 % were mild, 1.9 % were moderate, and 0.0 % were severe. Statistical analysis showed no association between tolerance and the pharmaceutical form used (p > 0.05) and indicated similar tolerance for both preparations.


CONCLUSIONS
Based on the results obtained, the excellent clinical tolerance of both pharmaceutical forms of IVIG UNC can be confirmed.
Mahieu
A C
AC
Laboratorio de Hemoderivados, Universidad Nacional de Córdoba, Avda. Valparaiso s/n, Ciudad Universitaria, X5000 HRA Córdoba, Argentina. caromah@hemo.unc.edu.ar
Sisti
A M
AM
Joekes
S
S
Manfredi
M J
MJ
D000293:Adolescent; D000328:Adult; D000368:Aged; D001118:Argentina; D001327:Autoimmune Diseases / Q000628:therapy; D002648:Child; D002675:Child, Preschool; D005260:Female; D005612:Freeze Drying; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use*; D007153:Immunologic Deficiency Syndromes / Q000628:therapy; D007223:Infant; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009080:Mucocutaneous Lymph Node Syndrome / Q000628:therapy; D011208:Powders; D011358:Product Surveillance, Postmarketing; D012189:Retrospective Studies; D012996:Solutions
D016756:Immunoglobulins, Intravenous; D011208:Powders; D012996:Solutions