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.
Media Articles Related to Gamunex (Immune Globulin Intravenous Human)
Nplate® (romiplostim) study in The Lancet shows significant increase in durable platelet response among children with immune thrombocytopenia
Source: Immune System / Vaccines News From Medical News Today [2016.04.21]
Amgen has announced that The Lancet published results from a Phase 3 randomized, double-blind, placebo-controlled study of Nplate® (romiplostim) in children with symptomatic immune...
Thrombocytopenia (Low Platelet Count)
Source: MedicineNet Fifth Disease Specialty [2015.04.30]
Title: Thrombocytopenia (Low Platelet Count)
Category: Diseases and Conditions
Created: 5/11/2009 12:00:00 AM
Last Editorial Review: 4/30/2015 12:00:00 AM
Published Studies Related to Gamunex (Immune Globulin Intravenous Human)
Evaluation of intravenous anthrax immune globulin for treatment of inhalation
Bacillus anthracis toxins can be neutralized by antibodies against protective
antigen (PA), a component of anthrax toxins. Anthrivig (human anthrax
immunoglobulin), also known as AIGIV, derived from plasma of humans immunized
with BioThrax (anthrax vaccine adsorbed), is under development for the treatment
of toxemia following exposure to anthrax spores.
Treatment of neonatal sepsis with intravenous immune globulin. [2011.09.29]
BACKGROUND: Neonatal sepsis is a major cause of death and complications despite antibiotic treatment. Effective adjunctive treatments are needed. Newborn infants are relatively deficient in endogenous immunoglobulin. Meta-analyses of trials of intravenous immune globulin for suspected or proven neonatal sepsis suggest a reduced rate of death from any cause, but the trials have been small and have varied in quality... CONCLUSIONS: Therapy with intravenous immune globulin had no effect on the outcomes of suspected or proven neonatal sepsis.
Standard-dose intravenous anti-D immunoglobulin versus intravenous immunoglobulin in the treatment of newly diagnosed childhood primary immune thrombocytopenia. [2011.05]
CONCLUSIONS: A single bolus dose of 50 mug/kg of IV anti-D is a safe and effective first-line treatment in newly diagnosed ITP in childhood and mucosal bleeding is a poor prognostic factor for treatment with IVIG.
Misleading hepatitis B test results due to intravenous immunoglobulin administration: implications for a clinical trial of rituximab in immune thrombocytopenia. [2010.12]
BACKGROUND: Rituximab may cause reactivation of hepatitis B virus (HBV) even in patients with remote HBV infection. Thus, the presence of hepatitis B core antibodies (anti-HBc) was an exclusion criterion for a randomized trial of rituximab for patients with immune thrombocytopenia. A high seroprevalence of anti-HBc observed among patients screened for the trial prompted this substudy to investigate for an association between anti-HBc seropositivity and exposure to intravenous immunoglobulin (IVIG)... CONCLUSIONS: Passive transfer of anti-HBc from certain IVIG products may lead to misinterpretation of hepatitis test results with implications for treatment and clinical trial eligibility. To avoid misleading test results, anti-HBc should be measured before or 3 months after IVIG administration; alternatively an IVIG product known to be free of anti-HBc should be used. (c) 2010 American Association of Blood Banks.
Safety and tolerability of immune globulin intravenous in chronic inflammatory demyelinating polyradiculoneuropathy. [2010.09]
BACKGROUND: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a common inflammatory neuropathy that can be progressive, stepwise progressive, or relapsing and remitting. OBJECTIVES: To further evaluate the long-term safety and tolerability of immune globulin intravenous, 10% caprylate-chromatography purified immune globulin intravenous in CIDP... CONCLUSION: Data support a favorable safety and tolerability profile for administration of immune globulin intravenous, 10% caprylate-chromatography purified as CIDP maintenance therapy. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00220740.
Clinical Trials Related to Gamunex (Immune Globulin Intravenous Human)
Subconjunctival IVIg (Gamunex-C) Injection for Corneal Neovascularization and Inflammatory Conditions [Recruiting]
The purpose of the study is to test the investigational drug Gamunex-C on the growth of
blood vessels over the cornea. This study is being conducted by Dr. Balamurali Ambati at the
Moran Eye Center at the University of Utah.
The cornea is the clear outer front part of the eye. In corneal neovascularization, blood
vessels grow over the cornea. Corneal neovascularization and ocular anterior segment
inflammations are sight-threatening conditions. Lipid deposition and edema with subsequent
scar formation can compromise corneal clarity irreversibly. Corneal neovascularization is
also a well recognized risk factor for corneal graft failure. In its natural state, the
cornea is a site of immune privilege well suited to tissue transplantation. Once
vascularized, there is direct exposure of corneal antigens to circulating host immune
mechanisms greatly increasing the chance of rejection [Collaborative Corneal Transplantation
Melting or inflammation in the anterior chamber, cornea, or ocular surface can cause
irreversible scarring or destruction of the optical elements of the eye, which can
Current standard of care for such conditions includes use of topical steroids and sometimes
immunosuppressants (e. g., cyclosporine). These do not address a common underlying corneal
neovascularization or melting.
This is a Phase 1 clinical trial of subconjunctival IVIg (Gamunex-C) injection for treatment
of corneal neovascularization in the setting of corneal transplantation with
neovascularization. Candidates for corneal transplantation with corneal neovascularization
in one or more quadrants crossing more than 0. 5mm over the limbus will be identified for
inclusion in our study.
Pharmacokinetics, Safety, and Tolerability of Subcutaneous GAMUNEX-C in Pediatric Subjects With Primary Immunodeficiency [Completed]
The purpose of this open-label study is to evaluate the pharmacokinetics, safety, and
tolerability of subcutaneously (SC; under the skin) administered GAMUNEX-C compared to
intravenously (IV; through the vein) administered GAMUNEX-C in subjects 2-16 years of age
with Primary Immunodeficiency.
A Study to Find How Safe and Effective GAMMAPLEX® is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP) [Completed]
To determine if GAMMAPLEX raises the platelet count of subjects with chronic ITP to a
threshold of 50 x 109/L, similar to that of published response >60%. Also to assess the
safety of GAMMAPLEX and determine if platelet counts are maintained at 50 x 109/L in
subjects with chronic ITP for.
Trial of the Efficacy of Intravenous Immunoglobulin for Treating Women With Unexplained Secondary Recurrent Miscarriage [Completed]
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 Immunoglobulins in Complex-regional Pain Syndrome [Not yet recruiting]
The purpose of this study is to determine whether intravenous immunoglobulins are effective
in the treatment of complex-regional pain syndrome.
Reports of Suspected Gamunex (Immune Globulin Intravenous Human) Side Effects
Haemolytic Anaemia (7),
Antibody Test Positive (5),
Infusion Related Reaction (5),
Encephalitis (3), more >>