SUMMARY
GAMMAGARD S/D, Immune Globulin Intravenous (Human) [IGIV] is a solvent/detergent treated, sterile, freeze-dried preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. The product is manufactured by the Cohn-Oncley cold ethanol fractionation process followed by ultrafiltration and ion exchange chromatography. Source material for fractionation may be obtained from another U.S. licensed manufacturer. The manufacturing process includes treatment with an organic solvent/detergent mixture,1,2 composed of tri-n-butyl phosphate, octoxynol 9 and polysorbate 80.3 The GAMMAGARD S/D manufacturing process provides a significant viral reduction in
in vitro
studies.3 These studies, summarized in Table 1, demonstrate virus clearance during GAMMAGARD S/D manufacturing using infectious human immunodeficiency virus, Types 1 and 2 (HIV-1, HIV-2); bovine viral diarrhea virus (BVD), a model virus for hepatitis C virus; sindbis virus (SIN), a model virus for lipid-enveloped viruses; pseudorabies virus (PRV), a model virus for lipid-enveloped DNA viruses such as herpes; vesicular stomatitis virus (VSV), a model virus for lipid-enveloped RNA viruses; hepatitis A virus (HAV) and encephalomyocarditis virus (EMC), a model virus for non-lipid enveloped RNA viruses; and porcine parvovirus (PPV), a model virus for non-lipid enveloped DNA viruses.3 These reductions are achieved through a combination of process chemistry, partitioning and/or inactivation during cold ethanol fractionation and the solvent/detergent treatment.3
GAMMAGARD S/D is not indicated in patients with selective IgA deficiency where the IgA deficiency is the only abnormality of concern (see WARNINGS section).
GAMMAGARD S/D is indicated for the treatment of primary immunodeficient states, such as: congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immuno-deficiencies.6,7 This indication was supported by a clinical trial of 17 patients with primary immunodeficiency who received a total of 341 infusions. GAMMAGARD S/D is especially useful when high levels or rapid elevation of circulating IgG are desired or when intramuscular injections are contraindicated (e.g., small muscle mass).
GAMMAGARD S/D is indicated for prevention of bacterial infections in patients with hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell Chronic Lymphocytic Leukemia (CLL). In a study of 81 patients, 41 of whom were treated with GAMMAGARD, Immune Globulin Intravenous (Human), bacterial infections were significantly reduced in the treatment group.8,9 In this study, the placebo group had approximately twice as many bacterial infections as the IGIV group. The median time to first bacterial infection for the IGIV group was greater than 365 days. By contrast, the time to first bacterial infection in the placebo group was 192 days. The number of viral and fungal infections, which were for the most part minor, was not statistically different between the two groups.
When a rapid rise in platelet count is needed to prevent and/or to control bleeding in a patient with Idiopathic Thrombocytopenic Purpura, the administration of GAMMAGARD S/D, should be considered.
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NEWS HIGHLIGHTS
Published Studies Related to Gammagard S / D (Immune Globulin Intravenous)
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 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.
Phase II, Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial of a Polyclonal Anti-Staphylococcus aureus Capsular Polysaccharide Immune Globulin in Treatment of Staphylococcus aureus Bacteremia. [2007.12]
New treatment modalities are needed for the treatment of infections due to multidrug-resistant Staphylococcus aureus.High levels of opsonizing antibodies were maintained for the initial 4 weeks.
Clinical Trials Related to Gammagard S / D (Immune Globulin Intravenous)
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.
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 (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.
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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Page last updated: 2009-10-20
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