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https://www.readbyqxmd.com/read/27342758/pharmacokinetics-safety-and-tolerability-of-subcutaneous-immune-globulin-injection-human-10%C3%A2-caprylate-chromatography-purified-gamunex%C3%A2-c-in-pediatric-patients-with-primary-immunodeficiency-disease
#1
Jennifer Heimall, Junliang Chen, Joseph A Church, Rhonda Griffin, Isaac Melamed, Gary I Kleiner
PURPOSE: This phase 4, multicenter, open-labeled, single-sequence, crossover study in pediatric patients (ages 2 to 16) with primary immunodeficiency disease (PID) evaluated the pharmacokinetics, safety, and tolerability for subcutaneously (SC) administered 10 % caprylate/chromatography purified human immune globulin injection (IGIV-C, GAMUNEX®) compared with intravenously (IV) administered IGIV-C. METHODS: This study included a screening phase, run-in phase (where required), IV treatment phase, SC treatment phase, and end of study/early termination visit...
August 2016: Journal of Clinical Immunology
https://www.readbyqxmd.com/read/27340624/advanced-drug-delivery-and-targeting-technologies-for-the-ocular-diseases
#2
REVIEW
Jaleh Barar, Ayuob Aghanejad, Marziyeh Fathi, Yadollah Omidi
INTRODUCTION: Ocular targeted therapy has enormously been advanced by implementation of new methods of drug delivery and targeting using implantable drug delivery systems (DDSs) or devices (DDDs), stimuli-responsive advanced biomaterials, multimodal nanomedicines, cell therapy modalities and medical bioMEMs. These technologies tackle several ocular diseases such as inflammation-based diseases (e.g., scleritis, keratitis, uveitis, iritis, conjunctivitis, chorioretinitis, choroiditis, retinitis, retinochoroiditis), ocular hypertension and neuropathy, age-related macular degeneration and mucopolysaccharidosis (MPS) due to accumulation of glycosaminoglycans (GAGs)...
2016: BioImpacts: BI
https://www.readbyqxmd.com/read/27077919/fatigue-pain-anxiety-and-depression-in-guillain-barr%C3%A3-syndrome-and-chronic-inflammatory-demyelinating-polyradiculoneuropathy
#3
Ingemar S J Merkies, Bernd C Kieseier
BACKGROUND: In the clinical evaluation of patients with Guillain-Barré syndrome (GBS) and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), scant attention is paid to symptoms such as fatigue, pain and anxiety/depression. We aimed at addressing seminal studies that focused on the burden of these symptoms and their impact on quality of life (QoL) in these conditions. SUMMARY: Fatigue, pain, and anxiety/depression are increasingly being recognized in patients with GBS and CIDP, although their pathophysiological provenance remains unknown...
2016: European Neurology
https://www.readbyqxmd.com/read/25852966/immunoglobulin-resistance-in-kawasaki-disease
#4
Georgios A Hartas, Syed Shahrukh Hashmi, Chi Pham-Peyton, Emmanouil Tsounias, John T Bricker, Monesha Gupta-Malhotra
Background: The aim of this study was to identify risk factors for immunoglobulin resistance, including clinical symptoms such as arthritis and the pH of intravenous immunoglobulin. Methods: The data of children with Kawasaki disease who had received immunoglobulin were evaluated. Data regarding the brand of immunoglobulin administered were abstracted from the pharmacy records. Results: Eighty consecutive children with Kawasaki disease were evaluated (Mdn age=28 months, 66% male). The prevalence of immunoglobulin resistance was 30%...
March 1, 2015: Pediatric Allergy, Immunology, and Pulmonology
https://www.readbyqxmd.com/read/25392130/a%C3%AE-anti-idiotypic-antibodies-are-present-in-intravenous-immunoglobulin-and-are-produced-in-mice-following-its-administration
#5
David A Loeffler, Andrea C Klaver, Mary P Coffey
The effects of intravenous immunoglobulin (IVIG) products were recently examined in patients with Alzheimer's disease (AD). Although encouraging results were obtained in pilot studies, later trials produced negative results. The rationale for these studies was that IVIG contains antibodies to amyloid-beta (Aβ). However, if Aβ anti-idiotypic antibodies (antibodies which bind to anti-Aβ antibodies) are present in IVIG or induced by its administration, these antibodies could potentially reduce its neuroprotective effects in AD...
June 2015: Autoimmunity
https://www.readbyqxmd.com/read/25090414/intravenous-immunoglobulin-for-hypogammaglobulinemia-after-lung-transplantation-a-randomized-crossover-trial
#6
RANDOMIZED CONTROLLED TRIAL
David J Lederer, Nisha Philip, Debbie Rybak, Selim M Arcasoy, Steven M Kawut
BACKGROUND: We aimed to determine the effects of treatment with intravenous immunoglobulin on bacterial infections in patients with hypogammaglobulinemia (HGG) after lung transplantation. METHODS: We performed a randomized, double-blind, placebo-controlled two-period crossover trial of immune globulin intravenous (IVIG), 10% Purified (Gamunex, Bayer, Elkhart, IN) monthly in eleven adults who had undergone lung transplantation more than three months previously. We randomized study participants to three doses of IVIG (or 0...
2014: PloS One
https://www.readbyqxmd.com/read/24859060/specific-binding-of-intravenous-immunoglobulin-products-to-tau-peptide-fragments
#7
Lynnae M Smith, Mary P Coffey, David A Loeffler
The effects of intravenous immunoglobulin (IVIG) products are being evaluated in Alzheimer's disease (AD) patients. IVIG contains antibodies to tau protein, the main constituent of neurofibrillary tangles (NFTs). Tau has microtubule binding domain (MBD) repeats which are thought to be necessary for its aggregation, a key process in NFT formation. Tau's N-terminal region may also contribute to its aggregation and to the neurotoxicity of its soluble oligomers. This study examined the specific binding of IVIG products Gammagard, Gamunex, and Flebogamma to a tau N-terminal fragment (tau 45-73), tau's four MBD repeat sequences (tau 244-274, 275-305, 306-336, and 337-368), and a tau C-terminal fragment (tau 422-441)...
August 2014: International Immunopharmacology
https://www.readbyqxmd.com/read/24804899/immune-globulins-and-same-day-thrombotic-events-as-recorded-in-a-large-health-care-database-during-2008-to-2012
#8
Gayathri Sridhar, Bola F Ekezue, Hector S Izurieta, Nandini Selvam, Mikhail V Ovanesov, Hozefa A Divan, Yideng Liang, Basil Golding, Richard A Forshee, Steven A Anderson, Mikhail Menis
BACKGROUND: Thrombotic events (TEs) are rare and serious adverse events after administration of immune globulin (IG) products. Our study evaluated the occurrence of same-day TEs for different IG products and ascertained potential risk factors. STUDY DESIGN AND METHODS: This retrospective cohort study utilized HealthCore's Integrated Research Database (HIRD) to assess individuals exposed to IGs during 2008 to 2012. IG products were identified using recorded procedure codes and TEs were ascertained using ICD-9-CM diagnosis codes...
October 2014: Transfusion
https://www.readbyqxmd.com/read/23928186/comparison-of-elisa-measurements-of-anti-a%C3%AE-concentrations-and-percentages-of-specific-binding-to-a%C3%AE-between-unfractionated-intravenous-immunoglobulin-products-and-their-purified-anti-a%C3%AE-antibodies
#9
COMPARATIVE STUDY
Andrea C Klaver, Mary P Coffey, Lynnae M Smith, David A Loeffler
Intravenous immunoglobulin (IVIG) products are being investigated as possible therapeutic agents for mild cognitive impairment and Alzheimer's disease (AD). Anti-Aβ antibodies have been measured by ELISA in unfractionated IVIG products and in affinity-purified antibodies from these products, but it is unclear if similar results are obtained with these two approaches. Measurements of anti-Aβ antibodies in unfractionated IVIG may be confounded by the presence of polyvalent antibodies which can bind to multiple antigens, including those on ELISA plates; whether this is an issue when measuring anti-Aβ antibodies in purified antibody eluates from IVIG is also unknown...
July 2013: Immunology Letters
https://www.readbyqxmd.com/read/23669333/intravenous-immunoglobulin-products-contain-specific-antibodies-to-recombinant-human-tau-protein
#10
Lynnae M Smith, Mary P Coffey, Andrea C Klaver, David A Loeffler
Intravenous immunoglobulin (IVIG) products are prepared from plasma immunoglobulins from healthy donors. Pilot studies suggest that IVIG may stabilize cognitive functioning in patients with mild-to-moderate Alzheimer's disease. This study measured antibodies to recombinant human tau protein in the IVIG products Gammagard (Baxter), Gamunex (Talecris), and Flebogamma (Grifols). Anti-tau antibodies were measured by ELISA, subtracting IVIG's polyvalent binding from its binding to tau-coated wells to calculate specific anti-tau antibody levels...
August 2013: International Immunopharmacology
https://www.readbyqxmd.com/read/23603176/home-ivig-for-cidp-a-focus-on-patient-centred-care
#11
Hans D Katzberg, Vilija Rasutis, Vera Bril
Objective: To determine the safety and tolerability of home-based intravenous immunoglobulin (IVIG) (Gamunex) as maintenance treatment in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) in Canada. Methods: We enrolled ten subjects with CIDP who had previously received IVIG in the hospital setting to receive the comparable IVIG dose (1-2 g/kg/month) in the home for six months. The patients were evaluated in the clinic at three months and at six months to evaluate their clinical status as well as the safety and tolerability of IVIG...
May 2013: Canadian Journal of Neurological Sciences. le Journal Canadien des Sciences Neurologiques
https://www.readbyqxmd.com/read/23456255/bioavailability-of-igg-administered-by-the-subcutaneous-route
#12
Melvin Berger, Stephen Jolles, Jordan S Orange, John W Sleasman
PURPOSE: US licensing studies of subcutaneous IgG (SCIG) calculate dose adjustments necessary to achieve area under the curve (AUC) of serum IgG vs. time on SCIG that is non-inferior to that on intravenous IgG (IVIG), within the FDA-set limit of ±20%. The results are interpreted as showing that different SCIGs differ in bioavailability. We used three approaches to determine if the bioavailabilities were actually different. METHODS: Dose adjustments and AUCs from published licensing studies were used to calculate bioavailabilities using the formula: Bioavailability (% of IVIG) = AUC(SCIG) ÷ AUC(IVIG) x 1/Dose Adjustment...
July 2013: Journal of Clinical Immunology
https://www.readbyqxmd.com/read/23215767/subcutaneous-immunoglobulins-product-characteristics-and-their-role-in-primary-immunodeficiency-disease
#13
REVIEW
Isaac Melamed, Alessandro Testori, Zvi Spirer
Research on the role of subcutaneous immunoglobulin in primary immunodeficiency disease (PIDD) is ongoing. We analyzed pivotal studies for four subcutaneous immunoglobulin products: IGSC 10% (Gammagard(®) Liquid), IGIV-C 10% (Gamunex(®)-C), IGSC 16% (Vivaglobin(®)) and IGSC 20% (Hizentra(®)). To identify similarities and differences between products, we examined infusion parameters, adverse event profiles and improvements in tolerability over time. Maximum volume infused was 30 mL/site for IGSC 10%, 34 mL/site for IGIV-C 10%, 15 mL/site for IGSC 16% and 25 mL/site for IGSC 20%...
December 2012: International Reviews of Immunology
https://www.readbyqxmd.com/read/23003576/in-vitro-and-in-vivo-properties-differ-among-liquid-intravenous-immunoglobulin-preparations
#14
F Dhainaut, P-O Guillaumat, H Dib, G Perret, A Sauger, C de Coupade, M Beaudet, M Elzaabi, L Mouthon
OBJECTIVE: To compare in vitro and in vivo biological and biochemical properties of five liquid intravenous immunoglobulin (IVIg) preparations licensed for therapeutic use in Europe. METHODS: ClairYg(®) was compared in a blinded manner to four other liquid IVIg preparations licensed in Europe (Octagam(®) , Kiovig(®) , Gamunex(®) , Privigen(®) ). Three batches of each preparation were tested, except for the IgG repertoires and the animal model. RESULTS: Levels of anti-A and anti-B antibodies were lower in ClairYg(®) (0·11/0·11) relative to a positive EDQM standard and Octagam(®) (0·11/0·08) than in other preparations (0·33-0·69/0·42-0·46)...
February 2013: Vox Sanguinis
https://www.readbyqxmd.com/read/22579294/pathogen-safety-profile-of-a-10-igg-preparation-manufactured-using-a-depth-filtration-modified-process
#15
Deborah Barnette, Nathan J Roth, Joann Hotta, Kang Cai, Michelle Gall, Randy Hartwell, Jonathan D Kent, Todd Willis
Gamunex®-C is a highly purified liquid 10% IgG preparation manufactured by a process that includes caprylate precipitation and incubation, and chromatography steps. In the original process, caprylate precipitation was followed by cloth filtration to remove impurities. The highly porous cloth filter has since been replaced with a tight depth filter. The impact of this process modification on pathogen reduction and product is presented. Virus and prion reduction was determined under set-point conditions using scaled-down models of the manufacturing process, and at or outside operating limits to determine robustness...
July 2012: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/21631364/biocompatibility-of-pooled-human-immunoglobulin-gamunex-10-%C3%A2-with-ocular-infusion-solutions-bss%C3%A2-and-bss-plus%C3%A2-an-in-vitro-evaluation-of-a-potential-antitoxin-treatment-for-infectious-endophthalmitis
#16
Dennis P Han, William J O'Brien, Brian Higgins
PURPOSE: Gamunex 10% (Talecris Biotherapeutics, Research Triangle Park, NC), a commercially available preparation of pooled human immunoglobulin G, has been proposed as an antitoxin therapy against bacterial toxins released in infectious endophthalmitis. Its biocompatibility with two commonly used intraocular infusion fluids was evaluated to determine feasibility of its clinical application in endophthalmitis treatment. METHODS: Gamunex 10% was mixed with BSS or BSS Plus (Alcon Laboratories, Fort Worth, TX) such that it constituted a range of 1...
August 2011: Journal of Ocular Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/21562253/comparison-of-ivig-and-plex-in-patients-with-myasthenia-gravis
#17
RANDOMIZED CONTROLLED TRIAL
D Barth, M Nabavi Nouri, E Ng, P Nwe, V Bril
OBJECTIVE: Both IV immunoglobulin (IVIg) and plasma exchange (PLEX) are immunomodulatory treatments used to treat patients with myasthenia gravis (MG), but the choice of which treatment to administer to patients is limited due to lack of evidence from adequately powered, masked, randomized, standardized trials. METHODS: We randomized 84 patients with moderate to severe MG defined as a Quantitative Myasthenia Gravis Score for disease severity (QMGS) of >10.5 and worsening weakness to IVIg (Gamunex®, Talecris Biotherapeutics) 1 g/kg/day for 2 consecutive days or PLEX (Caridian Spectra) 1...
June 7, 2011: Neurology
https://www.readbyqxmd.com/read/21265884/exogenous-immunoglobulin-downregulates-t-cell-receptor-signaling-and-cytokine-production
#18
Daniel S Tawfik, Katelyn R Cowan, Alexandra M Walsh, Wendy S Hamilton, Frederick D Goldman
Intravenous immune globulin (IVIG), a polyvalent solution of pooled human immunoglobulin, is a potent immunomodulating agent. It is currently approved to treat autoimmune diseases, including idiopathic thrombocytopenia purpura, autoimmune hemolytic anemia, and Kawasaki disease. The basis of IVIG's immunomodulatory properties is not entirely understood. Proposed mechanisms include Fc receptor blockade, interference with cytokine network, and provision of anti-idiotypic antibodies. IVIG has also been shown to affect T-lymphocyte function, although a direct effect has been difficult to reconcile given the lack of immunoglobulin or Fc-receptors on T cells...
February 2012: Pediatric Allergy and Immunology
https://www.readbyqxmd.com/read/21168611/impact-of-pretransplant-intravenous-immunoglobulin-administration-on-anti-ab0-antibody-levels-in-ab0-incompatible-living-donor-kidney-transplantation
#19
F C Renner, S Wienzek-Lischka, A Feustel, G Bein, W A Stertmann, W Padberg, R Weimer
BACKGROUND: From March 2007 to July 2010, we performed 14 AB0-incompatible (AB0i) living kidney transplantations using donor blood group-specific immunoadsorption (IA), anti-CD20 monoclonal antibody, and intravenous immunoglobulin (IVIG) pretreatment. METHODS: To analyze the effect of a presumed anti-donor blood group-specific antibody transfer by IVIG administration (0.5 g/kg; 5.4 ± 0.9 days pretransplant), we assessed AB0i antibody titers in different IVIG preparations and evaluated their impact on patient AB0i antibody titers...
December 2010: Transplantation Proceedings
https://www.readbyqxmd.com/read/21040143/understanding-the-consequences-of-chronic-inflammatory-demyelinating-polyradiculoneuropathy-from-impairments-to-activity-and-participation-restrictions-and-reduced-quality-of-life-the-ice-study
#20
RANDOMIZED CONTROLLED TRIAL
Ingemar S J Merkies, Richard A C Hughes, Peter Donofrio, Vera Bril, Marinos C Dalakas, Kim Hanna, Hans-Peter Hartung, Norman Latov, Pieter A van Doorn, Chunqin Deng
A randomized trial (ICE trial) in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) demonstrated significantly more improvement with intravenous immunoglobulin (Gamunex(®), Talecris Biotherapeutics, Inc., Research Triangle Park, NC) than placebo. To understand the relationship between CIDP impairments, activity and participation restrictions, and quality of life (QoL) in this trial, we investigated the association between scales representing these outcome levels. Gamunex or placebo was given every 3 weeks for up to 24 weeks to 117 patients in an initial treatment period after which treatment failures were crossed over (alternative treatment)...
September 2010: Journal of the Peripheral Nervous System: JPNS
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