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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 Antiphospholipid Syndrome Specialty [2015.12.17]
Title: Human Immunodeficiency Virus (HIV)
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 12/17/2015 12:00:00 AM

Acquired Immunodeficiency Syndrome
Source: MedicineNet Microsporidiosis Specialty [2015.04.16]
Title: Acquired Immunodeficiency Syndrome
Category: Diseases and Conditions
Created: 2/3/2010 12:00:00 AM
Last Editorial Review: 4/16/2015 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

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...

Evaluation of sex, race, body mass index and pre-vaccination serum progesterone levels and post-vaccination serum anti-anthrax protective immunoglobulin G on injection site adverse events following anthrax vaccine adsorbed (AVA) in the CDC AVA human clinical trial. [2014]
site AEs... CONCLUSIONS: Female and non-black participants had a higher proportion of AVA

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...

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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) [Completed]
To determine if GAMMAPLEX raises the platelet count of subjects with chronic ITP to a threshold of 50 x 109/L, similar to that of published response >60%. Also to assess the safety of GAMMAPLEX and determine if platelet counts are maintained at 50 x 109/L in subjects with chronic ITP for.

Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases. [Completed]
The main objective of this study is to see if GAMMAPLEX is efficacious with respect to Food and Drug Administration (FDA) minimal requirements (no more than 1 serious, acute, bacterial infection per subject per year) in subjects with Primary Immunodeficiency Diseases (PID). The secondary objectives are to assess the safety and tolerability of GAMMAPLEX and to determine if GAMMAPLEX has a pharmacokinetic (PK) profile comparable with that of intact Immunoglobulin G (IgG) in subjects with PID.

A Study to Find Out How Safe and Effective Gammaplex® is in Young People With Primary Immunodeficiency [Completed]
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

Trial of the Efficacy of Intravenous Immunoglobulin for Treating Women With Unexplained Secondary Recurrent Miscarriage [Completed]

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.

An Open-Label Study to Evaluate the Efficacy of High-Dose Gammaplex in Children on the Autism Spectrum [Active, not recruiting]
If autism is the consequence of a chronic inflammatory process preventing the infant brain from forming the proper neural connections, then treatment that reduces inflammation might have a positive impact on autism. IGIV treatment has been known to suppress inflammation and has been used in the treatment of inflammatory conditions and autoimmune diseases.

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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: 2015-12-17

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