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Gamunex (Immune Globulin Intravenous Human) - Summary

 
 



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 HIGHLIGHTS

Media Articles Related to Gamunex (Immune Globulin Intravenous Human)

Thrombocytopenia (Low Platelet Count)
Source: MedicineNet Fifth Disease Specialty [2014.01.08]
Title: Thrombocytopenia (Low Platelet Count)
Category: Diseases and Conditions
Created: 5/11/2009 12:00:00 AM
Last Editorial Review: 1/8/2014 12:00:00 AM

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Published Studies Related to Gamunex (Immune Globulin Intravenous Human)

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.

Intravenous immunoglobulin therapy in autoimmune mucocutaneous blistering diseases: a review of the evidence for its efficacy and safety. [2010]
Intravenous immunoglobulin (IVIg) is a biologic agent that is being increasingly used in the treatment of autoimmune and chronic inflammatory disorders. It is approved by the US FDA for the treatment of primary immunodeficiencies, immune thrombocytopenic purpura, Kawasaki disease, bone marrow transplantation in patients aged over 20 years, chronic B-cell lymphocytic leukemia, and pediatric AIDS...

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Clinical Trials Related to Gamunex (Immune Globulin Intravenous Human)

Pharmacokinetics, Safety, and Tolerability of Subcutaneous GAMUNEX-C in Pediatric Subjects With Primary Immunodeficiency [Recruiting]
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 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.

Evaluating the Effectiveness of Intravenous Immunoglobulin Therapy in Autoimmune Autonomic Ganglionopathy [Not yet recruiting]
The purpose of the study is to see if administering intravenous immune globulin (IVIG) (putting immune globulin directly into your blood) helps to improve the symptoms of orthostatic hypotension (sudden fall in blood pressure when a person stands up) and quality of life in men and women who have autoimmune autonomic ganglionopathy (AAG).

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.

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Reports of Suspected Gamunex (Immune Globulin Intravenous Human) Side Effects

Haemolytic Anaemia (7)Dyspnoea (6)Haemolysis (6)Antibody Test Positive (5)Infusion Related Reaction (5)Nausea (5)Hypotension (4)Thrombophlebitis (4)Chills (3)Encephalitis (3)more >>


Page last updated: 2014-01-08

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