WARNING: ACUTE RENAL DYSFUNCTION and ACUTE RENAL FAILURE
Use of Immune Globulin Intravenous (IGIV) products, particularly those containing sucrose, have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephropathy, and death.1 Patients at risk of acute renal failure include those with any degree of pre-existing renal insufficiency, diabetes mellitus, advanced age (above 65 years of age), volume depletion, sepsis, paraproteinemia, or receiving known nephrotoxic drugs (see
Warnings and Precautions [5.2]
). Gammaplex does not contain sucrose.
For patients at risk of renal dysfunction or failure, administer Gammaplex at the minimum infusion rate practicable (see
Dosage and Administration [2.3], Warnings and Precautions [5.2]
Gammaplex is a ready to use sterile solution of polyclonal human Immunoglobulin G for IV administration.
Gammaplex is an Immune Globulin Intravenous (Human), 5% Liquid indicated for the replacement therapy of primary humoral immunodeficiency (PI). This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
Media Articles Related to Gammaplex (Human Immunoglobulin G)
Human Immunodeficiency Virus (HIV)
Source: MedicineNet Loss, Grief, and Bereavement Specialty [2014.03.03]
Title: Human Immunodeficiency Virus (HIV)
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 3/3/2014 7:32:12 PM
Acquired Immunodeficiency Syndrome
Source: MedicineNet Human Immunodeficiency Virus (HIV, AIDS) Specialty [2013.05.21]
Title: Acquired Immunodeficiency Syndrome
Category: Diseases and Conditions
Created: 2/3/2010 12:31:00 PM
Last Editorial Review: 5/21/2013 12:00:00 AM
Human Immunodeficiency Virus
Source: MedicineNet Interstitial Pneumonia Specialty [2006.05.22]
Title: Human Immunodeficiency Virus
Category: Diseases and Conditions
Last Editorial Review: 5/22/2006
Published Studies Related to Gammaplex (Human Immunoglobulin G)
Mother-infant transfer of anti-human papillomavirus (HPV) antibodies following
vaccination with the quadrivalent HPV (type 6/11/16/18) virus-like particle
The exploratory immunogenicity objective of this analysis was to characterize the
titer of vaccine human papillomavirus (HPV)-type immunoglobulins in both
peripartum maternal blood and the cord blood of infants born to women who
received blinded therapy.
Oral priming with Salmonella Typhi vaccine strain CVD 909 followed by parenteral boost with the S. Typhi Vi capsular polysaccharide vaccine induces CD27+IgD-S. Typhi-specific IgA and IgG B memory cells in humans. [2011.02]
Attenuated live oral typhoid vaccine candidate CVD 909 constitutively expresses Salmonella Typhi capsular polysaccharide antigen (Vi). A randomized, double-blind, heterologous prime-boost clinical study was conducted to determine whether immunity to licensed parenteral Vi vaccine could be enhanced by priming with CVD 909...
Oral priming with Salmonella Typhi vaccine strain CVD 909 followed by parenteral
boost with the S. Typhi Vi capsular polysaccharide vaccine induces CD27+IgD-S.
Typhi-specific IgA and IgG B memory cells in humans. 
Attenuated live oral typhoid vaccine candidate CVD 909 constitutively expresses
Salmonella Typhi capsular polysaccharide antigen (Vi). A randomized,
double-blind, heterologous prime-boost clinical study was conducted to determine
whether immunity to licensed parenteral Vi vaccine could be enhanced by priming
with CVD 909...
Safety and immunogenicity of a novel Staphylococcus aureus vaccine: results from the first study of the vaccine dose range in humans. [2010.12]
Merck V710 is a novel vaccine containing the conserved Staphylococcus aureus iron surface determinant B shown to be protective in animal models. A phase I, multicenter, double-blind study of the dose range was conducted to assess the immunogenicity and safety of an adjuvanted liquid formulation of V710...
Seroprevalence and correlates of human papillomavirus 16/18 seropositivity among young women in Costa Rica. [2010.11]
BACKGROUND: Serological indicators of human papillomavirus (HPV) infection are being used to differentiate HPV-naive from previously infected women in vaccine and epidemiologic/clinical studies. We investigated HPV16 and 18 seroepidemiology among young, unvaccinated women aged between 18 and 25... CONCLUSIONS: The increasing seroprevalence observed with time since first sex suggests that HPV serology is a cumulative marker of HPV exposure. However, many DNA infected women were seronegative; thus, serology is an imperfect measure of past exposure to cervical HPV, at best. Additionally, we found no evidence of assay cross-reactivity.
Clinical Trials Related to Gammaplex (Human Immunoglobulin G)
A Study to Find How Safe and Effective GAMMAPLEX« is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP) [Recruiting]
The primary objective is to determine if BPL's GAMMAPLEX raises the platelet count of
subjects with chronic ITP to a threshold of 50 x 109/L, similar to that of a historical
control. The secondary objectives are: 1) to determine the safety of GAMMAPLEX at the
dosage used in this study. 2) to determine if GAMMAPLEX maintains platelet counts of │ 50 x
109/L in subjects with chronic ITP for a period of time similar to that of a historical
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.
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 Study to Find Out How Safe and Effective Gammaplex« is in Young People With Primary Immunodeficiency [Recruiting]
The main objective is to determine the efficacy of Gammaplex by measuring the number of
serious acute bacterial infections during treatment with Gammaplex over a 12 month period.
The secondary objectives are to assess the safety and tolerability of Gammaplex and to
compare the data collected from adult subjects with PID from the GMX01 study
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).
Reports of Suspected Gammaplex (Human Immunoglobulin G) Side Effects
International Normalised Ratio Decreased (4),
Pulmonary Embolism (3),
Drug Interaction (2),
Chest Pain (2),
Abdominal Pain (1),
Viith Nerve Paralysis (1), more >>
Page last updated: 2014-03-03