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Safety, Efficacy and Pharmacokinetics of a New 10% Liquid Intravenous Immunoglobulin (IVIG) in Patients with Primary Immunodeficiency
by
Rehman, Syed M.
, Church, Joseph A.
, Melamed, Isaac
, Moy, James
, Lumry, William
, Suez, Daniel
, Strausbaugh, Steven
, Wasserman, Richard L.
, Schroeder, Harry
, Elkayam, David
, Harris, James
, Stein, Mark
, Ballow, Mark
, White, Martha
in
Adolescent
/ Adult
/ Agammaglobulinemia - therapy
/ Aged
/ Bacterial Infections - immunology
/ Bacterial Infections - prevention & control
/ Biomedical and Life Sciences
/ Biomedicine
/ Child
/ Common Variable Immunodeficiency - therapy
/ Female
/ Genetic Diseases, X-Linked - therapy
/ Humans
/ IgG Deficiency - genetics
/ IgG Deficiency - therapy
/ Immunoglobulins, Intravenous - administration & dosage
/ Immunoglobulins, Intravenous - adverse effects
/ Immunoglobulins, Intravenous - pharmacokinetics
/ Immunoglobulins, Intravenous - therapeutic use
/ Immunology
/ Infectious Diseases
/ Internal Medicine
/ Male
/ Medical Microbiology
/ Middle Aged
/ Young Adult
2012
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Safety, Efficacy and Pharmacokinetics of a New 10% Liquid Intravenous Immunoglobulin (IVIG) in Patients with Primary Immunodeficiency
by
Rehman, Syed M.
, Church, Joseph A.
, Melamed, Isaac
, Moy, James
, Lumry, William
, Suez, Daniel
, Strausbaugh, Steven
, Wasserman, Richard L.
, Schroeder, Harry
, Elkayam, David
, Harris, James
, Stein, Mark
, Ballow, Mark
, White, Martha
in
Adolescent
/ Adult
/ Agammaglobulinemia - therapy
/ Aged
/ Bacterial Infections - immunology
/ Bacterial Infections - prevention & control
/ Biomedical and Life Sciences
/ Biomedicine
/ Child
/ Common Variable Immunodeficiency - therapy
/ Female
/ Genetic Diseases, X-Linked - therapy
/ Humans
/ IgG Deficiency - genetics
/ IgG Deficiency - therapy
/ Immunoglobulins, Intravenous - administration & dosage
/ Immunoglobulins, Intravenous - adverse effects
/ Immunoglobulins, Intravenous - pharmacokinetics
/ Immunoglobulins, Intravenous - therapeutic use
/ Immunology
/ Infectious Diseases
/ Internal Medicine
/ Male
/ Medical Microbiology
/ Middle Aged
/ Young Adult
2012
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Safety, Efficacy and Pharmacokinetics of a New 10% Liquid Intravenous Immunoglobulin (IVIG) in Patients with Primary Immunodeficiency
by
Rehman, Syed M.
, Church, Joseph A.
, Melamed, Isaac
, Moy, James
, Lumry, William
, Suez, Daniel
, Strausbaugh, Steven
, Wasserman, Richard L.
, Schroeder, Harry
, Elkayam, David
, Harris, James
, Stein, Mark
, Ballow, Mark
, White, Martha
in
Adolescent
/ Adult
/ Agammaglobulinemia - therapy
/ Aged
/ Bacterial Infections - immunology
/ Bacterial Infections - prevention & control
/ Biomedical and Life Sciences
/ Biomedicine
/ Child
/ Common Variable Immunodeficiency - therapy
/ Female
/ Genetic Diseases, X-Linked - therapy
/ Humans
/ IgG Deficiency - genetics
/ IgG Deficiency - therapy
/ Immunoglobulins, Intravenous - administration & dosage
/ Immunoglobulins, Intravenous - adverse effects
/ Immunoglobulins, Intravenous - pharmacokinetics
/ Immunoglobulins, Intravenous - therapeutic use
/ Immunology
/ Infectious Diseases
/ Internal Medicine
/ Male
/ Medical Microbiology
/ Middle Aged
/ Young Adult
2012
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Safety, Efficacy and Pharmacokinetics of a New 10% Liquid Intravenous Immunoglobulin (IVIG) in Patients with Primary Immunodeficiency
Journal Article
Safety, Efficacy and Pharmacokinetics of a New 10% Liquid Intravenous Immunoglobulin (IVIG) in Patients with Primary Immunodeficiency
2012
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Overview
Introduction
An investigational 10% liquid intravenous immunoglobulin (IVIG) was studied in 63 patients with primary immunodeficiency (PID) at 15 study sites.
Methods
Patients were treated every 3 or 4 weeks with 254–1029 mg/kg/infusion of IVIG.
Results
Overall, Biotest-IVIG infusions were well tolerated. The proportion of infusions that were associated with adverse events during infusion, and up to 72 h after infusion, including those unrelated to study product, was 27.7% with an upper 95% confidence limit ≤30.6%. Two serious bacterial infections (SBIs) were observed resulting in a serious bacterial infection rate of 0.035 per person per year and an upper one-sided 99% confidence limit of ≤0.136 SBI/patient/year. The number of days of work or school missed due to infection were relatively low at 2.28 days/patient/year. Two patients were hospitalized for infection producing a rate of 0.21 hospitalization days/patient/year. The IgG half-life was approximately 30 days with variation among individuals.
Conclusions
Pharmacokinetic parameters of specific antibody activities were essentially the same as those of total IgG. Biotest-IVIG is safe and effective in the treatment of PID.
Publisher
Springer US,Springer Nature B.V
Subject
/ Adult
/ Agammaglobulinemia - therapy
/ Aged
/ Bacterial Infections - immunology
/ Bacterial Infections - prevention & control
/ Biomedical and Life Sciences
/ Child
/ Common Variable Immunodeficiency - therapy
/ Female
/ Genetic Diseases, X-Linked - therapy
/ Humans
/ Immunoglobulins, Intravenous - administration & dosage
/ Immunoglobulins, Intravenous - adverse effects
/ Immunoglobulins, Intravenous - pharmacokinetics
/ Immunoglobulins, Intravenous - therapeutic use
/ Male
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