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Gammaplex (Human Immunoglobulin G) - Summary

 
 



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 SUMMARY

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.


See all Gammaplex indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Gammaplex (Human Immunoglobulin G)

Human Immunodeficiency Virus (HIV)
Source: MedicineNet abacavir 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 12:00:00 AM
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
Created: 12/31/1997
Last Editorial Review: 5/22/2006

Research rules out Hepatitis C as cause of mental impairment in HIV patients
Source: HIV / AIDS News From Medical News Today [2014.12.18]
Advances in treatment for human immunodeficiency virus (HIV) have made it possible for people with HIV to survive much longer.

First and only treatment for multicentric Castleman's disease, SYLVANT, now approved in Canada
Source: Blood / Hematology News From Medical News Today [2014.12.08]
Janssen Inc. has announced that Health Canada has approved SYLVANTTM (siltuximab) for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus...

more news >>

Published Studies Related to Gammaplex (Human Immunoglobulin G)

Intranasal vaccination with a replication-deficient influenza virus induces heterosubtypic neutralising mucosal IgA antibodies in humans. [2014]
We investigated the cross-neutralising potential of serum and nasal wash samples from volunteers who were intranasally immunised once with a monovalent replication-deficient delNS1-H1N1 influenza virus vaccine (7.7log10TCID50/volunteer). Eight out of twelve (8/12) vaccinees responded to vaccination with a significant increase of antibody levels in serum IgG ELISA, mucosal IgA ELISA, MNA or HAI...

Mother-infant transfer of anti-human papillomavirus (HPV) antibodies following vaccination with the quadrivalent HPV (type 6/11/16/18) virus-like particle vaccine. [2012]
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. [2011]
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...

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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 control.

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

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.

more trials >>

Reports of Suspected Gammaplex (Human Immunoglobulin G) Side Effects

International Normalised Ratio Decreased (4)Pulmonary Embolism (3)Drug Interaction (2)Headache (2)Pyrexia (2)Chest Pain (2)Abdominal Pain (1)Chills (1)Tachycardia (1)Viith Nerve Paralysis (1)more >>


Page last updated: 2014-12-18

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