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Wolfgang Frenzel, Stefan Wietek, Tor-Einar Svae, Anette Debes, Daniel Svorc
OBJECTIVE: To evaluate the tolerability and safety of Octagam<sup>®</sup> 5% and 10% across all indications, ages, and treatment regimens, using data from four non-interventional post-authorization safety studies (PASS); this analysis was performed following changes in the preparation of raw material used to manufacture Octagam. METHODS: All four studies included in- and out-patients prescribed Octagam for treatment of their medical condition. Physicians used case report forms to document baseline demographics, Octagam treatment details, and data on the efficacy of Octagam, and recorded all adverse drug reactions (ADRs) and other safety data...
November 2016: International Journal of Clinical Pharmacology and Therapeutics
Stephen D Betschel, Richard J Warrington, Robert Schellenberg
In Canada, intravenous immune globulin (IVIg) products are licensed for six disease indications, however it has been demonstrated that patients with a number of other conditions also benefit from IVIg. Here we report the routine clinical use of Octagam(®) 10 % across three Canadian institutions. A total of 135 patients were treated with Octagam(®), for conditions represented by five distinct indication groups. The results of this review indicate that Octagam(®) has been well adopted and is prescribed to Canadian patients similar to other IVIg products...
2016: Allergy, Asthma, and Clinical Immunology
Hyewon Kwon, Amanda C Crisostomo, Hayley Marie Smalls, John M Finke
The fraction of IgG antibodies with anti-oligomeric Aβ affinity and surface sialic acid was compared between Octagam and Gammagard intravenous immunoglobulin (IVIG) using two complementary surface plasmon resonance methods. These comparisons were performed to identify if an elevated fraction existed in Gammagard, which reported small putative benefits in a recent Phase III clinical trial for Alzheimer's Disease. The fraction of anti-oligomeric Aβ IgG was found to be higher in Octagam, for which no cognitive benefits were reported...
2015: PloS One
Danielli C Bichuetti-Silva, Fernanda P Furlan, Fernanda A Nobre, Camila T M Pereira, Tessa R T Gonçalves, Mariana Gouveia-Pereira, Rafael Rota, Lusinete Tavares, Juliana T L Mazzucchelli, Beatriz T Costa-Carvalho
Intravenous immunoglobulin (IVIG) is increasingly recommended for many diseases apart from primary immunodeficiency diseases (PID). Although effective and safe, adverse reactions may occur. We conducted a 2-year prospective observational study in 117 patients with PID who received regular IVIG replacement therapy at a median dose of 600 mg/kg every 3 to 4 weeks to examine IVIG's adverse effects; 1765 infusions were performed (mean=15/patient) in 75 males and 42 females (aged 3 months to 77 years) in 3 groups: ≤ 9 years (34...
December 2014: International Immunopharmacology
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
David A Loeffler
Intravenous immunoglobulin (IVIG) products are prepared from purified plasma immunoglobulins from large numbers of healthy donors. Pilot studies with the IVIG preparations Octagam and Gammagard in individuals with mild-to-moderate Alzheimer's disease (AD) suggested stabilization of cognitive functioning in these patients, and a phase II trial with Gammagard reported similar findings. However, subsequent reports from Octagam's phase II trial and Gammagard's phase III trial found no evidence for slowing of AD progression...
2013: Journal of Neuroinflammation
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
Takeshi Tabira, Shin-Ei Matsumoto, Haifeng Jin
In order to avoid Abeta-induced autoimmune encephalitis, several monoclonal and polyclonal antibodies are in clinical trials. These are bapineuzumab, solanezumab, ponezumab, gantenerumab, BAN2401, gammaguard and octagam. Since each antibody has a different antigen epitope of Abeta, anti-amyloid activities are different. It is unknown which antibody is effective for Alzheimer disease, and we must wait for the result of clinical trials. Some patients who developed tissue amyloid plaque immuno-reactive (TAPIR) antibody showed slower decline after AN-1792 vaccination...
November 2011: Rinshō Shinkeigaku, Clinical Neurology
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
Tadeusz Robak, Claudia Mainau, Barbara Pyringer, Krzysztof Chojnowski, Krzysztof Warzocha, Anna Dmoszynska, Jan Straub, Paul Imbach
Intravenous immunoglobulin (IVIg) has an established role in the treatment of immune thrombocytopenia (ITP). The safety and efficacy of a new ready-to-use IVIg 10% formulation (octagam(®) 10%) were investigated in a prospective phase III study in 116 adult patients with ITP (platelet count ≤20×10(9)/l). Sixty-six patients had chronic ITP and 49 were newly diagnosed. Patients received octagam 10% 1 g/kg/day on two consecutive days; infusion rate was adjusted according to tolerability to a maximum of 0·12 ml/kg/minute...
October 2010: Hematology (Amsterdam, Netherlands)
Anette Debes, Maria Bauer, Sybille Kremer
PURPOSE: Following the approval of Octagam in 1995, an open prospective observational cohort study has been initiated to observe the tolerability of the intravenous immunoglobulin Octagam. This study aimed to evaluate the long-term safety profile of Octagam in daily use in the treatment of various primary (PID) and secondary (SID) immunodeficiencies and autoimmune diseases (AID). METHODS: Within a time period of 10 years, data were collected in 310 study sites. The treating physicians documented patient characteristics, treatment parameters and the occurrence of an adverse drug reaction (ADR) by using detailed case record forms (CRF)...
September 2007: Pharmacoepidemiology and Drug Safety
A Chrissafidou, M Malek, E Musch
INTRODUCTION: Treatment of Crohn's disease is based on anti-inflammatory and immunosuppressive therapy. Over time, however, approx. 20 % of patients develop steroid resistance. In these cases, alternative treatment methods are required. Short-term application of intravenous immunoglobulin (IVIg) may serve as an additional alternative. PATIENTS AND METHODS: In 19 steroid-resistant patients (case collection over 15 years) suffering from Crohn's disease (mean CDAI 284...
July 2007: Zeitschrift Für Gastroenterologie
H F Rabenau, L Biesert, T Schmidt, G Bauer, J Cinatl, H W Doerr
SARS-coronavirus (SARS-CoV) is a newly emerged, highly pathogenic agent that caused over 8000 human infections with nearly 800 deaths between November 2002 and September 2003. While direct person-to-person transmission via respiratory droplets accounted for most cases, other modes have not been ruled out. SARS-CoV viraemia does not seem to reach high titres, however, it has to be excluded that virus transmission may occur via blood transfusion or application of therapeutic plasma products, e.g. fresh-frozen plasma or single components derived thereof...
June 2005: Biologicals: Journal of the International Association of Biological Standardization
Hans D Ochs, Paul J Pinciaro
Octagam is an intravenous immunoglobulin preparation registered in Europe for treating primary immunodeficiency diseases (PID). The present clinical trial was designed to demonstrate that Octagam meets the minimal efficacy requirement of the U.S. Food and Drug Administration-that treatment should result in </=1 serious infection/subject/year. The objectives of this clinical trial were to show that Octagam meets this requirement, and to confirm the safety of Octagam. Forty-six subjects with well-defined PID received Octagam (either 400-600 mg/kg every 28 days or 300-450 mg/kg every 21 days) for 12 months...
May 2004: Journal of Clinical Immunology
E I Alekseeva, I E Shakhbazian, K B Zholobova
Preparations of intravenous immunoglobulin (sandoglobulin, pentaglobin, intraglobin F, octagam) were given daily or each other day in a course dose 0.3-1 g/kg to 43 patients aged 4 to 15 years. Eight of them had allergosepsis, 22--allergoseptic variant of juvenile rheumatoid arthritis (JRA) and 13--systemic JRA and generalized joint syndrome. The treatment induced remission in patients with allergosepsis, prednisolone was discontinued. JRA patients coped with fever, eruption, polyserositis, infection symptoms...
2001: Klinicheskaia Meditsina
A V Barinov, V V Ol'mezov
Many patients with sepsis are immunocompetent. They respond well to standard combinations of antibiotics and cardiovascular support. However, immunocompetent patients, particularly small-for-date newborns, are in need of stronger immune protection. Although the mechanisms due to which antibody preparations yield positive effects are not quite clear, clinical studies carried out in many countries and our own results indicate a high protective effect of intravenous immunoglobulins and necessitate their use at least in intensive care departments...
May 1999: Anesteziologiia i Reanimatologiia
A E Fiane, V Videm, O J Mellbye, A Foerster, O R Geiran, I P Gladhaug, J L Svennevig, T E Mollnes
Intravenous immunoglobulin (IVIG) (Octagam), was used to determine the effect on hyperacute rejection in an ex vivo xenograft model. Six pig kidneys were perfused with IVIG and fresh human AB blood, and six control pig kidneys were simultaneously perfused with albumin and blood from the same donation. The survival of the IVIG-perfused xenografts (median, 6.5 h) was significantly (P = 0.03) longer than the albumin-perfused xenografts (median, 3.5 h). Complement was activated in both groups. The administration of IVIG to the perfused blood resulted in immediate and significantly higher complement activation in the fluid phase as compared with the albumin group...
June 1998: Scandinavian Journal of Immunology
T E Mollnes, I H Andreassen, K Høgåsen, C E Hack, M Harboe
Intravenous immunoglobulins (IVIG) are increasingly used for treatment of inflammatory diseases, and the modulation of complement may contribute to some of its beneficial effects. IVIG may bind C1q and activated C3 and C4, and enhance inactivation of C3b. We have previously shown that IVIG inhibited complement-mediated lysis solely via its Fc part through interaction with the classical pathway. In the present study we have investigated whole IVIG (Octagam, and Sandoglobulin) and the monomer, dimer and multimer fractions of Octagam with respect to complement activation in serum and inhibition of complement lysis of red cells...
July 1997: Molecular Immunology
B Brenner
OBJECTIVE: The safety and efficacy of Octagam, a solvent detergent (SD) virus inactivated intravenous gammaglobulin, were evaluated in 54 patients who received 301 infusions of Octagam for a total amount of 9301 grams, during 24 months. METHODS: Adverse reactions during and after Octagam infusion were carefully recorded. Serum IgG and ALT levels were recorded monthly. Antibodies to HIV, HBV and HCV were recorded every 3 months. RESULTS: In 22 chronic lymphocytic leukemia patients and 4 multiple myeloma patients, the monthly infusion of 0...
May 1996: Clinical and Experimental Rheumatology
L Biesert
OBJECTIVE: A validation study of the viral safety of a new polyvalent intravenous immunoglobulin (OCTAGAM) according to EU-guideline III/8115/89-EN and the requirements of the Federal Agency for Sera and Vaccines in Germany was undertaken in May 1994. The following processing steps were analyzed: Cohn-Oncley fractionation, solvent/detergent (SD) treatment, pH 4 exposure, storage of the final product at low pH and immune neutralisation. METHODS: The following virus reduction factors were obtained: Cohn-Oncley fractionation: HIV-1 > 5...
May 1996: Clinical and Experimental Rheumatology
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