Differences among available immunoglobulin preparations for intravenous use

Skvaril, F; Gardi, Andreas

doi:10.1097/00006454-198805001-00010

Cited by 22 publications

(11 citation statements)

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“…For the same reasons, IgG3 preparations must be carefully manufactured so that trace amounts of contaminating serum proteases are removed. Avoidance of manufacturing steps which affect IgG3 structure, such as the use of ␤-propiolactone for viral inactivation, would be important (39,40). None of the viral neutralization assays described here contained complement.…”

Section: Discussionmentioning

confidence: 99%

Immunoglobulin G3 from Polyclonal Human Immunodeficiency Virus (HIV) Immune Globulin Is More Potent than Other Subclasses in Neutralizing HIV Type 1

Scharf¹,

Golding

King

et al. 2001

J Virol

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Section: Discussionmentioning

confidence: 99%

Immunoglobulin G3 from Polyclonal Human Immunodeficiency Virus (HIV) Immune Globulin Is More Potent than Other Subclasses in Neutralizing HIV Type 1

Scharf¹,

Golding

King

et al. 2001

J Virol

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“…In the mid 1990s an outbreak of hepatitis C occurred in Europe and was associated with Ig therapy [40][41][42][43]. Specific methods have been developed to assure maximal removal of pathogens [44], including donor screening for HIV and hepatitis B and C virus, detergent and solvent treatment, virus inactivation, destruction [45,46], and minor differences in IgA levels exist between the current products.…”

Section: Production and Content Of Immunoglobulinsmentioning

confidence: 99%

“…The repertoire of immune antibodies is thought to reflect the infectiological experience of the donor population. To best cover the needs of patients, it is believed that Ig therapy is optimal when the recipient belongs to the same population as the donors [45,46].…”

Section: Production and Content Of Immunoglobulinsmentioning

confidence: 99%

Immunoglobulin treatment in primary antibody deficiency

Maarschalk-Ellerbroek

Hoepelman

Ellerbroek

2011

International Journal of Antimicrobial Agents

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The primary antibody deficiency syndromes are characterised by recurrent respiratory tract infections and the inability to produce effective immunoglobulin (Ig) responses. The best known primary antibody deficiencies are common variable immunodeficiency (CVID), X-linked agammaglobulinaemia (XLA), immunoglobulin G (IgG) subclass deficiency, and selective antibody deficiency with normal immunoglobulins (SADNI).Therapy in these patients consists of prophylactic antibiotics and/or Ig replacement therapy. Diagnostic delay remains common owing to limited awareness of the presenting features and may result in increased morbidity and mortality. Replacement therapy with immunoglobulins increases life expectancy and reduces the frequency and severity of infections, but the effect on end-organ damage is still unknown. Both intravenous immunoglobulin (IVIg) and subcutaneous immunoglobulin (SCIg) treatment appear to be safe, with comparable efficacy. A starting dose of 300-400 mg/kg/month in IVIg and 100 mg/week for SCIg is recommended. IgG trough levels should be >5 g/L for patients with agammaglobulinaemia and 3 g/L greater than the initial IgG level for patients with CVID; however, the clinical response should be foremost in choosing the dose and trough level. Infusion-related adverse reactions are generally mild owing to improved manufacturing processes. In this paper, aspects of Ig replacement therapy in primary antibody-deficient patients will be addressed.

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“…[6,44] As a consequence, IVIg formulations differ in composition (table II), which may result in different product efficacy and tolerability profiles. [37,41,42,[56][57][58][59] The main component of IVIg products is IgG (90-98%) [table II], which is the most common immunoglobulin in plasma and plays a major role in humoral immunity. However, all products also contain IgA and IgM antibodies in different concentrations along with T-helper type 2 (T h 2) cytokines and cytokine antagonists, and it is thought that all of these components contribute to both therapeutic and adverse effects of IVIg.…”

Section: Characteristics Of Intravenous Immunoglobulin (Ivig) Formulamentioning

confidence: 99%

“…use of chemicals or enzymes to inactivate viruses or reduce formation of aggregates that may contribute to adverse events) can also cause alterations in the distribution of IgG subclasses and loss of certain IgG subclasses, and can affect the structure and function of the Fc (constant) portion of the IgG molecule. [37,56,60,61] These changes can result in a reduced biologic activity. However, recent methods for removing or inactivating viruses (e.g.…”

Section: Characteristics Of Intravenous Immunoglobulin (Ivig) Formulamentioning

confidence: 99%

Relevant Criteria for Selecting an Intravenous Immunoglobulin Preparation for Clinical Use

Chérìn

Cabané

2010

BioDrugs

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Over the past several decades, the use of intravenous human normal immunoglobulin (IVIg) products in a diverse range of immunodeficiency, inflammatory and infectious disorders has increased significantly. Newer manufacturing processes have increased the yield of intact IVIg molecules and have also improved the tolerability and safety of these products, including reducing the transmission risk of blood-borne diseases. While there are no appreciable differences between the numerous commercially available IVIg products in terms of efficacy, different manufacturing processes and the final composition of IVIg products have resulted in different safety and tolerability profiles. The tolerability profile of different IVIg products may be idiosyncratic for individual patients and may not be predictable, based on product characteristics. Consequently, patients receiving an IVIg product should be carefully monitored at initial exposure, and switching of products should be avoided. To achieve the best outcomes in patients requiring IVIg therapy, treatment should be tailored to the patient's needs. The risk/benefit profile of an IVIg in relation to patient risk factors and the underlying immune deficiency, or autoimmune or inflammatory disorder should be considered when deciding on the most appropriate therapy.

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Differences among available immunoglobulin preparations for intravenous use

Cited by 22 publications

References 0 publications

Immunoglobulin G3 from Polyclonal Human Immunodeficiency Virus (HIV) Immune Globulin Is More Potent than Other Subclasses in Neutralizing HIV Type 1

Immunoglobulin G3 from Polyclonal Human Immunodeficiency Virus (HIV) Immune Globulin Is More Potent than Other Subclasses in Neutralizing HIV Type 1

Immunoglobulin treatment in primary antibody deficiency

Relevant Criteria for Selecting an Intravenous Immunoglobulin Preparation for Clinical Use

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