GAMUNEX SUMMARY
Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, (GAMUNEX®) is a ready-to-use sterile solution of human immune globulin protein for intravenous administration. GAMUNEX® 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. GAMUNEX® contains trace levels of fragments and IgA (average 0.046 mg/mL). IgM levels were at or below the limit of quantitation (0.002 g/L). 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 258 mOsmol/kg solvent, which is close to physiological osmolality (285-295 mOsmol/kg). The pH of GAMUNEX® is 4.0-4.5. GAMUNEX® contains no preservative.
GAMUNEX®, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, is indicated as replacement therapy of primary immunodeficiency states in which severe impairment of antibody forming capacity has been shown, such as congenital agammaglobulinemia, common variable immunodeficiency, X-linked immunodeficiency with hyper IgM, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies17-24.
GAMUNEX® is indicated in Idiopathic Thrombocytopenic Purpura to rapidly raise platelet counts to prevent bleeding or to allow a patient with ITP to undergo surgery5-10.
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NEWS HIGHLIGHTSMedia Articles Related to Gamunex (Immune Globulin Intravenous Human)
Thrombocytopenia (Low Platelet Count)
Source: MedicineNet Chickenpox (Varicella) Specialty [2009.05.13]
Title: Thrombocytopenia (Low Platelet Count)
Category: Diseases and Conditions
Created: 5/11/2009
Last Editorial Review: 5/13/2009
Ligand Announces Approval For Revolade(R) In Europe
Source: Blood / Hematology News From Medical News Today [2010.03.15]
Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) today announced that GlaxoSmithKline (NYSE: GSK) was granted marketing authorization from the European Commission (EC) for Revolade® (eltrombopag) for the oral treatment of thrombocytopenia (reduced platelet count) in adults with the blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP)...
Published Studies Related to Gamunex (Immune Globulin Intravenous Human)
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.
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...
A single dose of anti-D immunoglobulin raises platelet count as efficiently as intravenous immunoglobulin in newly diagnosed immune thrombocytopenic purpura in Korean children. [2008.08]
OBJECTIVE: The aim of this study is to compare the efficacy and safety of a single dose of anti-D immunoglobulin (anti-D) at 50 mug/kg to intravenous immunoglobulin (IVIG) in Korean children with acute immune thrombocytopenic purpura (ITP)... CONCLUSIONS: A single dose of 50 microg/kg of anti-D raised platelet count as efficiently as IVIG in newly diagnosed cases of ITP in Korean children. Although 50 microg/kg of anti-D had a greater effect on the hemoglobin concentration than IVIG, the adverse effects were found to be acceptable, and no serious events were observed.
Clinical Trials Related to Gamunex (Immune Globulin Intravenous Human)
A Trial of the Pharmacokinetics, Safety, and Tolerability of Subcutaneous Gamunex® in Primary Immunodeficiency [Active, not recruiting]
This study will investigate the pharmacokinetics (PK), safety and tolerability of GAMUNEX
administered subcutaneously (SC) in subjects with Primary Immune Deficiency (PID). Gamunex
is a ready to use 10% solution Immunoglobulin G (IgG) currently approved for intravenous (IV)
administration for the treatment of PID. The goal is to demonstrate based on PK evaluation
that Gamunex administered SC with an appropriate dose conversion factor will achieve a
steady-state AUC of plasma IgG to be non-inferior to that achieved by the corresponding dose
utilizing IV Gamunex therapy.
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.
Trial of the Efficacy of Intravenous Immunoglobulin for Treating Women With Unexplained Secondary Recurrent Miscarriage [Recruiting]
The investigators want to test whether infusions of intravenous immunoglobulin - a blood product known to modify immune responses - in early pregnancy will increase the chance of a
subsequent live birth in women with three or more miscarriages after a birth and a total of
at least four miscarriages. This will be done in a trial where 82 patients will be randomly
allocated to infusions with intravenous immunoglobulin or placebo during pregnancy.
Intravenous Immunoglobulin After Relapse in Vasculitis [Terminated]
Immune Globulin Intravenous (IGIV) For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) [Completed]
The intent of this study is to demonstrate the efficacy and safety of Immune Globulin
Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in newly or previously
diagnosed CIDP subjects. Eight courses of treatment with either placebo or IGIV-C will occur
every 3 weeks. Neurological function will be measured by INCAT scores. Patients who
deteriorate or show no improvement between day 16 and month 6 will receive the alternate
study drug for an additional 6 months.
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