GAMIMUNE N SUMMARY
Immune Globulin Intravenous (Human), 10% -- Gamimune® N, 10% treated with solvent/detergent is a sterile solution of human protein containing no preservative. Gamimune N, 10% consists of 9%-11% protein in 0.16-0.24 M glycine. Not less than 98% of the protein has the electrophoretic mobility of gamma globulin. Not less than 90% of the IgG is monomer. Also present are traces of IgA and of IgM. The distribution of IgG subclasses is similar to that found in normal serum. The measured buffer capacity is 35 mEq/L and the osmolality is 274 mOsmol/kg solvent.
Gamimune N, 10% is efficacious in the treatment of primary immunodeficiency states in which severe impairment of antibody forming capacity has been shown, such as: congenital agammaglobulinemias, common variable immunodeficiency, Wiskott-Aldrich syndrome, x-linked immunodeficiency with hyper IgM, and severe combined immunodeficiencies.5,21-23 Gamimune N, 10% is especially useful when high levels or rapid elevation of circulating antibodies are desired or when intramuscular injections are contraindicated.
In clinical situations in which a rapid rise in platelet count is needed to control bleeding or to allow a patient with ITP to undergo surgery, administration of Gamimune N, 10% should be considered.
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NEWS HIGHLIGHTS
Published Studies Related to Gamimune N (Immune Globulin)
A prospective, randomized, double-blinded, placebo-controlled study of human intravenous immunoglobulin for the acute management of presumptive primary immune-mediated thrombocytopenia in dogs. [2009.09]
BACKGROUND: Immune-mediated thrombocytopenia (IMT) is a common hematologic disorder in dogs... CONCLUSIONS AND CLINICAL IMPORTANCE: Compared with corticosteroids alone, adjunctive emergency therapy of a single hIVIG infusion was safe and associated with a significant reduction in platelet count recovery time and duration of hospitalization without increasing the expense of medical care in a small group of dogs with presumed pIMT.
Health-related quality-of-life improvements in CIDP with immune globulin IV 10%: the ICE Study. [2009.04.14]
BACKGROUND: Chronic inflammatory demyelinating polyradiculoneuropathy trials have demonstrated the efficacy of IV immunoglobulin vs placebo. However, these trails have not addressed the long-term impact on health-related quality of life (HRQoL)... CONCLUSIONS: Long-term therapy with immune globulin IV, 10% caprylate/chromatography purified, improves and maintains health-related quality of life in chronic inflammatory demyelinating polyradiculoneuropathy.
Intravenous immune globulin versus intravenous anti-D immune globulin for the treatment of acute immune thrombocytopenic purpura. [2008.12]
OBJECTIVE: The purpose of this study was to compare the efficacy and side effects of intravenous immunoglobulin (IVIG) with intravenous anti-D immunoglobulin for treatment of newly diagnosed acute childhood Idiopathic thrombocytopenic purpura (ITP)... CONCLUSION: In acute childhood ITP, initial treatment with IVIG (2g/Kg in divided dose) increased platelet count more rapidly and more significant than intravenous anti-D (single dose of 75 microg/kg) within the first 72 hours.
Effect of therapeutic integrin (CD11a) blockade with efalizumab on immune responses to model antigens in humans: results of a randomized, single blind study. [2008.11]
Efalizumab is a humanized monoclonal CD11a antibody approved for treatment of psoriasis. Its immunomodulatory effects led us study how immune responses are modified and the possible consequences for vaccinations in clinical practice... These results expand our knowledge of how immune responses are modulated in humans by CD11a blockade and have implications for vaccinations of patients treated with this agent.
Intravenous immunoglobulins in the treatment of immune neuropathies. [2008.10]
PURPOSE OF REVIEW: The aim of this review is to describe the value of high-dose polyclonal intravenous immunoglobulins as a treatment option in autoimmune disorders affecting the peripheral nervous system. RECENT FINDINGS: A randomized placebo-controlled trial in patients with chronic inflammatory demyelinating polyradiculoneuropathy revealed short-term and long-term efficacy and safety of intravenous immunoglobulins as a treatment option for the chronically inflamed peripheral nervous system...
Clinical Trials Related to Gamimune N (Immune Globulin)
Intravenous Immunoglobulin (IVIG) for Treatment of Unexplained Secondary Recurrent Miscarriage [Active, not recruiting]
Recurrent miscarriage is a prevalent reproductive problem that affects many couples who are
trying to establish a family. This clinical study will evaluate the effectiveness of
intravenous immunoglobulin (IVIG) in improving the live birth rate in couples who suffer from
secondary recurrent miscarriage. This study will help in providing an answer to the question
of whether IVIG is helpful in secondary recurrent miscarriage.
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Page last updated: 2009-10-20
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