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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)

Evaluation of intravenous anthrax immune globulin for treatment of inhalation anthrax. [2013]
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.

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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.

Intravenous Immunoglobulins in Severe and Refractory Solar Urticaria [Recruiting]
Solar urticaria is a rare but debilitating disease that can severely impact the quality of life, restricting outdoor activities. Treatment, based on sun protection and anti-histaminic drugs, is efficacious in 2 patients out of 3. In refractory patients, photodesensitization or immunosuppressive treatments such as cyclosporin A can be proposed. As in idiopathic urticaria, intravenous immunoglobulins (IVIG)have been shown, in a retrospective study of 7 patients, to dramatically improve 71% of patients. In an open-label prospective multicenter study, we aim to demonstrate the efficacy of a single IVIG administration (2g/kg) in 10 patients affected with severe and refractory solar urticaria.

Intravenous Immunoglobulin for PANDAS (Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections) [Recruiting]
Background:

- Some children experience a sudden onset of symptoms similar to those found in

obsessive-compulsive disorder that may be caused by the body's reaction to an infection with streptococcal bacteria, most commonly seen as strep throat or scarlet fever. When the body's immune system reacts against brain cells following a streptococcal infection, the condition is known as PANDAS (pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections). The immune system response can be inactivated by treatment with a drug known as intravenous immunoglobulin (IVIG). Because there is insufficient research on IVIG's effects on the immune system of children with PANDAS, including whether IVIG is helpful in treating obsessive-compulsive symptoms related to PANDAS, researchers are interested in examining whether IVIG is an appropriate treatment for PANDAS and its associated symptoms.

Objectives:

- To test the safety and effectiveness of intravenous immunoglobulin for the treatment of

obsessive-compulsive disorder in children with PANDAS (pediatric autoimmune neuropsychiatric disorder associated with streptococcal infection).

Eligibility:

- Children between 4 and 12 years of age who have obsessive-compulsive disorder (with or

without a tic disorder) with sudden onset of symptoms following Group A streptococcal bacterial infections.

Design:

- Participants will be screened by telephone to obtain medical history and other

information, followed by in-person screening at the National Institutes of Health Clinical Center.

- Participants will be admitted to the hospital to receive 2 days of infusions of either

IVIG or a placebo. Frequent blood samples, imaging studies, and other tests will be performed during this visit.

- Six weeks after the inpatient stay, participants will return for further blood samples

and other tests. Participants who did not receive the study drug, or who received the drug but did not respond to the initial IVIG infusion, will have the option to receive IVIG at this time.

- Followup visits will take place 3 months and 6 months after the first evaluation,

followed by yearly follow-ups for 3 additional years.

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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: 2014-11-30

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