Risks associated with the use of intravenous immunoglobulin 1 1This review article reflects the opinions of the authors and not necessarily those of the U.S. Food and Drug Administration.

Pierce, L. Ross; Jain, Nisha

doi:10.1016/s0887-7963(03)00038-5

Cited by 175 publications

(30 citation statements)

References 42 publications

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“…Direct Coombs' test changes from negative at baseline to positive were observed in 46.8% of patients, which is comparable to the rate of 37% reported for another IVIG product [22]. Transiently positive Coombs' tests are a wellknown phenomenon of IVIG treatment in general [31]. The timing of blood sampling and the analyses performed were not designed to detect and fully evaluate laboratory signs of hemolysis; no clinical signs of hemolytic anemia were observed in this study.…”

Section: Discussionsupporting

confidence: 58%

Safety and Efficacy of Privigen®, a Novel 10% Liquid Immunoglobulin Preparation for Intravenous Use, in Patients with Primary Immunodeficiencies

et al. 2008

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Purpose The present study was designed to evaluate the efficacy and safety of a novel, 10% liquid formulation of intravenous immunoglobulin, stabilized with 250 mmol/L L-proline (Privigen®), in patients with primary immunodeficiency disease. Materials and Methods Eighty adults and children diagnosed with common variable immunodeficiency or X-linked agammaglobulinemia received intravenous Privigen® infusions (200-888 mg/kg) at 3-or 4-week intervals over a 12-month period, according to their previously established maintenance dose. The primary endpoint was the annual rate of acute serious bacterial infections. Results There were six episodes of acute serious bacterial infections, corresponding to an annual rate of 0.08; the annual rate for all infections was 3.55. Mean serum IgG trough levels were between 8.84 and 10.27 g/L. A total of 1,038 infusions were administered, most of them at the maximum rate permitted (8.0 mg kg −1 min −1 ). Temporally associated adverse events, possibly or probably related to

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Section: Discussionsupporting

confidence: 58%

Safety and Efficacy of Privigen®, a Novel 10% Liquid Immunoglobulin Preparation for Intravenous Use, in Patients with Primary Immunodeficiencies

et al. 2008

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“…Bu durum özellikle önce-sinde böbrek fonksiyonlarında bozukluk olan yaşlı hastalarda IVIG içerisindeki sükroz ile ilişkilendiril-miştir. Günümüzde SIG preparatları sükroz içerme-mektedir ve SIG uygulaması sonrası böyle bir yan etki bildirilmemiştir (21,27) .…”

Section: Subkutan Immünglobülin Ilişkili Yan Etkilerunclassified

Subcutaneous Immunoglobulin Use in Children

Acar¹,

Somer²

2018

Cocuk Dergisi

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İnsan plazma kaynaklı immünglobülinler başta primer immün yetersizlik hastalıkları olmak üzere pek çok hastalığın tedavi seçenekleri arasında yer almaktadır. İmmünglobülin preparatları; intravenöz (IV), subkutan (SC) ya da intramüsküler (IM) yolla verilebilir. Son yıllarda subkutan immünglobülin (SIG) uygulaması, hasta konforunun daha yüksek, maliyetinin ve yan etki insidansının daha düşük olması nedeniyle tercih edilmektedir. Bu yazıda çocuk hastalarda SIG kullanımı ile ilgili güncel bilgiler özetlenmiştir.

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“…La dosis de IgG se ajusta hasta 1000 mg/kg de acuerdo con el grado de hipogammaglobulinemia, la gravedad de las infecciones y el daño de los órganos afectados. (GRADE A1) 7,46,47,48,49,50,51 R La primera infusión intravenosa para reemplazo en un paciente con IDP que no haya sido tratado previamente debe ser administrada a una velocidad de 0.5 a 1 mg/kg por minuto. Después de 15 minutos se debe incrementar la velocidad de 1.5 a 2.5 mg/kg por minuto.…”

Section: Dosis De Inmunoglobulinaunclassified

“…El aumento debe ser continuo, según la tolerancia, hasta 4 mg/kg por minuto. (GRADE A1) 7,15,50,51 R En las inmunodeficiencias primarias se administra 100 a 200 mg/kg de inmunoglobulina subcutánea por semana o 200 a 400 mg/kg cada 2 semanas. (GRADE A1) 15,43,45,52 R La misma dosis mensual de reemplazo que se utiliza con la IgIV se puede utilizar con la modalidad subcutánea, dividida en 4 o 2 semanas.…”

Section: Dosis De Inmunoglobulinaunclassified

Guía colombiana de práctica clínica para el uso de inmonuglobulinas en el tratamiento de reemplazo e inmunomodulación

Olivares

Olmos²,

Álvarez

et al. 2017

RAM

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Immunoglobulins are heterodimeric proteins composed of 2 heavy chains and 2 light chains. Human immunoglobulin G (IgG) is a plasma derivative and contains more than 95% of IgG. The composition of IgG subclasses is similar to that of normal human plasma. Immunoglobulin therapy was first introduced more than 50 years ago, and its use has been described in numerous diseases. In Colombia, the importance of this immunomodulatory resource prompted the need for clinical practice guidelines to be available for its use. For this reason, a multidisciplinary group of experts was brought together and distributed in working groups, by specialties, in order to develop an initial manuscript. Systematic literature searches were undertaken; identified evidences were evaluated and classified to support a preliminary draft that was discussed, analyzed and amended. Recommendations were issued on the use of intravenous immunoglobulin in pathologies that include primary and secondary immunodeficiencies, autoimmune diseases, neurological disorders, infections, transplants and miscellaneous conditions; grades were assigned to each one of them according to the GRADE system. The final result translated into recommendations that are put forth with the purpose to inform, guide and support on optimal use of this immunomodulatory resource.

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Risks associated with the use of intravenous immunoglobulin 1 1This review article reflects the opinions of the authors and not necessarily those of the U.S. Food and Drug Administration.

Cited by 175 publications

References 42 publications

Safety and Efficacy of Privigen®, a Novel 10% Liquid Immunoglobulin Preparation for Intravenous Use, in Patients with Primary Immunodeficiencies

Safety and Efficacy of Privigen®, a Novel 10% Liquid Immunoglobulin Preparation for Intravenous Use, in Patients with Primary Immunodeficiencies

Subcutaneous Immunoglobulin Use in Children

Guía colombiana de práctica clínica para el uso de inmonuglobulinas en el tratamiento de reemplazo e inmunomodulación

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