RESUMO
Inmunoglobulina G Endovenosa UNC is a 5% liquid Argentine intravenous immunoglobulin obtained from South American donors. This prospective trial was designed to evaluate if the product meets the minimal efficacy requirement of the US Food and Drug Administration of <1 serious infection/subject/year as well as its safety in pediatric patients with Primary Immunodeficiency Diseases. Thirty patients under the age of 18, with well-defined Primary Immunodeficiency Diseases received Inmunoglobulina G Endovenosa UNC (330-700 mg/kg every 3-4 weeks) for 6 months. Vital signs, laboratory abnormalities, adverse events and viral tests were assessed to evaluate safety. Two serious infections occurred (pneumonia and bacteriemia). The estimated infection rate was 0.114 serious infection/subject/year (95% CI, 0.003-0.2277). Minor adverse events occurred in 5.5% of infusions; fever and headache were the most common. Neither severe adverse events, nor abnormal laboratory values were observed. All viral assessments were negative. Inmunoglobulina G Endovenosa UNC meets the minimal efficacy requirement of the US Food and Drug Administration for pediatric Primary Immunodeficiency Diseases patients and showed efficacy and safety data comparable with other data published.
Assuntos
Imunoglobulinas Intravenosas/uso terapêutico , Síndromes de Imunodeficiência/tratamento farmacológico , Adolescente , Argentina , Criança , Pré-Escolar , Feminino , Humanos , Imunoglobulina G/sangue , Infecções/epidemiologia , Masculino , Resultado do TratamentoRESUMO
INTRODUCTION: 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. OBJECTIVES: 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. PATIENTS AND 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.
Assuntos
Imunoglobulinas Intravenosas/uso terapêutico , Adolescente , Adulto , Idoso , Argentina , Doenças Autoimunes/terapia , Criança , Pré-Escolar , Feminino , Liofilização , Humanos , Imunoglobulinas Intravenosas/administração & dosagem , Imunoglobulinas Intravenosas/efeitos adversos , Imunoglobulinas Intravenosas/química , Síndromes de Imunodeficiência/terapia , Lactente , Infusões Intravenosas , Masculino , Pessoa de Meia-Idade , Síndrome de Linfonodos Mucocutâneos/terapia , Pós , Vigilância de Produtos Comercializados , Estudos Retrospectivos , SoluçõesRESUMO
BACKGROUND: Intravenous immunoglobulin preparations are an effective therapy in several processes: primary and secondary immunodeficiencies, autoimmune and inflammatory disorders, infectious diseases and allergies, among others. This biological medicine must comply with three conditions: clinical tolerance, therapeutic efficacy and viral safety. OBJECTIVES: The aim of this study was to assess the therapeutic efficacy, clinical tolerance and viral safety of a regional intravenous immunoglobulin, manufactured by the Hemoderivatives Laboratory of the National University of Cordoba in Argentina (Inmunoglobulina G Endovenosa UNC), with plasma obtained from voluntary, unremunerated donors from Argentina, Chile and Uruguay. PATIENTS AND METHODS: The pharmacovigilance records of 448 infusions in 111 patients with different diseases were statistically evaluated. Clinical tolerance was evaluated by recording of adverse events, therapeutic efficacy was evaluated by taking into account the specific parameters of each disease, and viral safety was evaluated by analysis of serological markers of hepatitis B, hepatitis C and human immunodeficiency viruses before and after infusion. RESULTS: Adverse effects were observed in 4.6 % of total infusions, of which 3.1 % were mild, 1.3 were moderate and 0.2 % were severe. The therapeutic efficacy of the product was recorded in all diseases in which it was administered. Regarding viral safety, no seroconversions were registered in any of the records evaluated. CONCLUSIONS: The results of this study indicate that Inmunoglobulina G Endovenosa UNC is well tolerated, with good therapeutic efficacy and viral safety.
Assuntos
Imunoglobulinas Intravenosas/uso terapêutico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Anafilaxia/etiologia , Criança , Pré-Escolar , Grupos Diagnósticos Relacionados , Feminino , Hepatite Viral Humana/transmissão , Humanos , Imunoglobulina A/efeitos adversos , Imunoglobulinas Intravenosas/efeitos adversos , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Dor/etiologia , Vigilância de Produtos Comercializados , Prurido/etiologia , Estudos Retrospectivos , Resultado do TratamentoRESUMO
Immune thrombocytopenic purpura (ITP) is a bleeding disorder characterized by accelerated splenic removal of platelets opsonized with autoantibodies. Several different treatments have been tried in acute ITP patients, including intravenous immunoglobulin (IVIG) therapy. The aim of this paper was to assess the therapeutic efficacy, clinical tolerance and viral safety of Inmunoglobulina G Endovenosa-UNC, manufactured by Laboratorio de Hemoderivados, Cordoba National University, in the treatment of acute ITP patients. A prospective longitudinal study was carried out on 8 children, who were admitted to the Hospital de Niños de Córdoba, from July 1998 to June 1999. A dose of 1 g/Kg/day of Inmunoglobulina G Endovenosa-UNC was administered to those children whose platelet values remained < or = 20,000/mm3, 21 days after the first IVIG cycle. The observed results led us to conclude that Inmunoglobulina G Endovenosa-UNC is well tolerated and therapeutically effective in the treatment of acute ITP in children, with platelet values recovery, similar to those obtained with other IVIG. Moreover, it proved to be virally safe since the 8 patients were non reactive for viral markers of hepatitis B, hepatitis C and human immunodeficiency, 12 months after ending the treatment.
Assuntos
Imunoglobulinas Intravenosas/uso terapêutico , Púrpura Trombocitopênica Idiopática/tratamento farmacológico , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Estudos Longitudinais , Masculino , Contagem de Plaquetas , Estudos Prospectivos , Púrpura Trombocitopênica Idiopática/sangue , Resultado do TratamentoRESUMO
BACKGROUND AND OBJECTIVES: Intravenous immunoglobulin G (IVIG) preparations are used in several disorders: primary and secondary immunodeficiencies, autoimmune and systemic inflammatory diseases, and in infectious diseases as effective therapy. In this work, we report a method of processing IVIG (lyophilized and liquid) from Cohn fraction II (FII) paste. MATERIALS AND METHODS: The process included the following steps: virus inactivation by heat in a solution of FII, ultrafiltration, treatment at pH 4 with traces of pepsin, diafiltration and final formulation. Optimizations for each step on a small scale are described. The method has been effectively scaled-up. RESULTS: The final product contained at least 99% monomers plus dimers of IgG, a low anti-complementary activity (AcA) < 1 CH50/mg, and the remaining quality parameters fell within the range fixed by the European Pharmacopoeia. CONCLUSION: The method described is an effective way of preparing large quantities of IVIG (lyophilized and liquid) which fulfils the standard requirements of both the European Pharmacopoeia and the World Health Organization.
Assuntos
Imunoglobulina G , Imunoglobulinas Intravenosas , Liofilização , HumanosRESUMO
Immune thrombocytopenic purpura (ITP) is a bleeding disorder characterized by accelerated splenic removal of platelets opsonized with autoantibodies. Several different treatments have been tried in acute ITP patients, including intravenous immunoglobulin (IVIG) therapy. The aim of this paper was to assess the therapeutic efficacy, clinical tolerance and viral safety of Inmunoglobulina G Endovenosa-UNC, manufactured by Laboratorio de Hemoderivados, Cordoba National University, in the treatment of acute ITP patients. A prospective longitudinal study was carried out on 8 children, who were admitted to the Hospital de Niños de Córdoba, from July 1998 to June 1999. A dose of 1 g/Kg/day of Inmunoglobulina G Endovenosa-UNC was administered to those children whose platelet values remained < or = 20,000/mm3, 21 days after the first IVIG cycle. The observed results led us to conclude that Inmunoglobulina G Endovenosa-UNC is well tolerated and therapeutically effective in the treatment of acute ITP in children, with platelet values recovery, similar to those obtained with other IVIG. Moreover, it proved to be virally safe since the 8 patients were non reactive for viral markers of hepatitis B, hepatitis C and human immunodeficiency, 12 months after ending the treatment.