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Gamimune N (Immune Globulin) - Summary

 
 



GAMIMUNE N SUMMARY

Immune Globulin Intravenous (Human), 10% -- Gamimune® N, 10% treated with solvent/detergent is a sterile solution of human protein containing no preservative. Gamimune N, 10% 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. Not less than 90% of the IgG is monomer. Also present are traces of IgA and of IgM. 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 274 mOsmol/kg solvent.

Gamimune N, 10% is efficacious in the treatment of primary immunodeficiency states in which severe impairment of antibody forming capacity has been shown, such as: congenital agammaglobulinemias, common variable immunodeficiency, Wiskott-Aldrich syndrome, x-linked immunodeficiency with hyper IgM, and severe combined immunodeficiencies.5,21-23 Gamimune N, 10% is especially useful when high levels or rapid elevation of circulating antibodies are desired or when intramuscular injections are contraindicated.

In clinical situations in which a rapid rise in platelet count is needed to control bleeding or to allow a patient with ITP to undergo surgery, administration of Gamimune N, 10% should be considered.
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NEWS HIGHLIGHTS

Published Studies Related to Gamimune N (Immune Globulin)

Clinical evaluation of a single dose of immune plasma for treatment of canine parvovirus infection. [2012]
OBJECTIVE: To evaluate the efficacy of administration of a single 12-mL dose of canine parvovirus (CPV)-immune plasma for treatment of CPV enteritis... CONCLUSIONS AND CLINICAL RELEVANCE: Administration of a single 12-mL dose of immune plasma soon after the onset of CPV enteritis in dogs was not effective in ameliorating clinical signs, reducing viremia, or hastening hematologic recovery.

Immunology in the Clinic Review Series; focus on allergies: basophils as biomarkers for assessing immune modulation. [2012]
Allergen-specific immunotherapy is an effective clinical treatment for hypersensitivity to many allergens... Better understanding the molecular mechanisms of basophil activation and desensitization and the relationship between suppression of these effector cells to clinical outcomes holds promise for further development and improvement in potential therapies for allergic diseases.

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.

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Clinical Trials Related to Gamimune N (Immune Globulin)

Multi-Drug Desensitization Protocol for Heart Transplant Candidates [Not yet recruiting]
Background: Patients may develop antibodies (human leukocyte antigen [HLA] alloantibodies) to other human tissues via pregnancy, transfusions or previous transplantation, which limits the ability to find an acceptable donor heart for transplantation. Such patients are at high risk for antibody mediated rejection, graft failure, and acute rejection (i. e. death). For successful transplantation, patients must receive organs from donors who lack the HLA antigens that correspond to their alloantibody specificities. No successful desensitization strategy currently exists.

Purpose: To determine if desensitization by deletion of immunologic memory with a multi-drug approach including anti-T and B cell therapies and anti-plasma cell therapy can effectively eliminate or significantly reduce alloantibody levels and permit highly sensitized patients to obtain a heart transplant. This therapy is anticipated to remove immunologic memory and will require re-immunization.

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.

Antibiotic Treatment and Intravenous Immunoglobulin Trial for PANDAS [Not yet recruiting]
An increasing body of evidence indicates that an immune basis might underline a number of pediatric neuropsychiatric disorders. Research studies found a subgroup of children who had Obsessive compulsive (OCD) and/or tic disorders following a Group A beta-hemolytic streptococcal (GAS) infection. The subgroup is identified by the acronym, PANDAS (pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections. More recently, several PANDAS variants have been described, including adult-onset variant. There are many evidences that OCD/tic symptoms could be due to an immunologic reaction against brain tissues following a streptococcal infection.

The purpose of this study is to know if sertraline (one of the SSRI approved by FDA to improve OCD/tic symptoms in these patients) plus antibiotic (benzathine penicillin G or azithromycin in case of penicillin allergy) is more effective than SSRI only.

Patients who will not respond to antibiotic will be treated with intravenous immunoglobulin (IVIG) in order to inactivate the immune reaction versus brain tissues.(No treatment response is based on the lack of a Y-BOCS score improvement of at least 35%).

Objectives:

- To determine the safety and efficacy of SSRI+AB compared to SSRI only.

- To test the safety and additional beneficial effects of high dose of IVIG on antibiotic

prophylaxis for the treatment of OCD symptoms in non-responders patients with PANDAS.

Study methodology:

- Participants will be screened to obtain medical history and other information at

Neurologic and Psychiatric Sciences Department of Florence University Hospital and at Paris-est University.

- Participants will receive a treatment of either SSRI+AB or SSRI+placebo for 12 weeks

(double-blind randomized trial)

- Patients who will not respond to AB will be admitted to the hospital to receive IVIG

for 5 days, for 5 consecutive months.

- Follow-up visits will take place 3 and 6 months after the first evaluation, followed by

6 months follow-ups for 3 additional years.

Blood samples (including blood cytokine determination), ECG, Doppler and 2-dimensional echocardiogram EEG, imaging studies (2 tesla MRI), and other tests will be performed both before and after the treatment with SSRI+AB or SSRI+placebo and in case also after IVIG treatment.

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Page last updated: 2013-02-10

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