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https://www.readbyqxmd.com/read/28079914/intravenous-immunoglobulin-in-pediatric-rheumatology-when-to-use-it-and-what-is-the-evidence
#1
Martha M Rodriguez, Linda Wagner-Weiner
Intravenous immunoglobulin (IVIG) is given to children with a variety of rheumatologic illnesses. The mechanism of action by which it exerts therapeutic effects is not well understood and likely differs in the medical conditions for which it is given. IVIG is approved by the US Food and Drug Administration and is the standard of care for Kawasaki disease, but most IVIG use in pediatric rheumatology is "off-label. " The literature supports the use of IVIG for juvenile dermatomyositis, although it is unclear whether its use should be limited to those children with more severe or refractory disease...
January 1, 2017: Pediatric Annals
https://www.readbyqxmd.com/read/28079913/intravenous-immunoglobulin-in-the-treatment-of-hematologic-disorders-in-pediatrics
#2
Gabriela Villanueva, Jill L O de Jong, Jennifer L McNeer
Intravenous immunoglobulin (IVIG) is pooled immunoglobulin G derived from human blood donors. It was introduced in the early 1980s to treat immunodeficiency disorders. Since then, its use has expanded to other fields such as neurology, rheumatology, and hematology. IVIG has been used to provide passive immunity in qualitative and quantitative immunoglobulin disorders, to neutralize antibodies in immune-mediated diseases, and as an immune modulatory agent. The difficulty of producing IVIG in high quantities, in addition to a growing list of "off-label" indications, has resulted in a worldwide shortage and increase in cost...
January 1, 2017: Pediatric Annals
https://www.readbyqxmd.com/read/28079912/intravenous-immunoglobulin-in-the-treatment-of-primary-immunodeficiency-diseases
#3
Deirdre De Ranieri, Nana Sarkoah Fenny
Intravenous immunoglobulin (IVIG) has been used as antibody replacement therapy in primary immunodeficiency diseases (PIDDs) for more than 50 years. Its role as a therapeutic agent has expanded over the past couple of decades as its anti-inflammatory and immune-modulatory mechanisms of action have been elucidated. It is now used "off-label" to treat other autoimmune diseases. This article focuses on the role of IVIG in the treatment of PIDDs characterized by absent or deficient antibody production. Replacement doses are given on a monthly basis in these conditions as a prophylactic measure to prevent acute and serious bacterial infections...
January 1, 2017: Pediatric Annals
https://www.readbyqxmd.com/read/28078215/off-label-therapies-for-testosterone-replacement
#4
REVIEW
Lorenzo DiGiorgio, Hossein Sadeghi-Nejad
The incidence of hypogonadism has been steadily increasing over the last few years. Exogenous testosterone has been the standard treatment for hypogonadal men, but is associated with suppression of spermatogenesis as well as other possible adverse effects. There are other medications, currently considered "off label" for androgen replenishment, that exert their effect through modulation of the hypothalamic-gonadal axis. These medications increase endogenous testosterone levels and offer a different therapeutic approach...
December 2016: Translational Andrology and Urology
https://www.readbyqxmd.com/read/28074548/annual-report-of-the-perinatology-committee-japan-society-of-obstetrics-and-gynecology-2015-proposal-of-urgent-measures-to-reduce-maternal-deaths
#5
Satoru Takeda, Jun Takeda, Keisuke Murakami, Takahiko Kubo, Hiromi Hamada, Maki Murakami, Shintaro Makino, Hiroaki Itoh, Takashi Ohba, Katsuhiko Naruse, Hiroaki Tanaka, Naohiro Kanayama, Shigeki Matsubara, Hiroshi Sameshima, Tomoaki Ikeda
Perinatal care in Japan has progressed rapidly in recent decades, remarkably reducing maternal, perinatal and neonatal mortality rates. This is attributable not only to the sustained efforts and dedication of past obstetricians and midwives, but also to the collective results achieved by the Japan Society of Obstetrics and Gynecology and healthcare administration, including research on advanced medical care, education, medical care improvements and establishing perinatal care centers. Although the maternal mortality rate was in steady decline until 2007 (3...
January 2017: Journal of Obstetrics and Gynaecology Research
https://www.readbyqxmd.com/read/28073872/gambling-disorder-a-side-effect-of-an-off-label-prescription-of-baclofen-literature-review
#6
Morgane Guillou-Landreat, Caroline Victorri Vigneau, Marie Gerardin
The use of high-dose baclofen emerged in 2008 in the treatment of alcohol-use disorders. Its prescription is still off-label in France, but recent trials have suggested the interest of using high doses for alcohol dependence, so we have to deal with an increase in its use. However, we still have few data about the adverse effects of a high-dose baclofen prescription, especially in complex addictive disorders. We present a case of a 32-year-old man who sought treatment for gambling disorders (GDs). He had complex addictive disorders, including alcohol-use disorders and GDs...
January 10, 2017: BMJ Case Reports
https://www.readbyqxmd.com/read/28068508/avoiding-chlorhexidine-burns-in-preterm-infants
#7
Mariano Paternoster, Massimo Niola, Vincenzo Graziano
Chlorhexidine is a skin antiseptic agent frequently used for off-label indications in NICUs. Changes to the safety labeling of chlorhexidine products for use in preterm infants were recently made because of the risk of severe chemical burns. We provide tips for a safer use of chlorhexidine to prevent injury in newborns and to help health care professionals protect themselves against burn injury claims.
January 6, 2017: Journal of Obstetric, Gynecologic, and Neonatal Nursing: JOGNN
https://www.readbyqxmd.com/read/28060176/bone-morphogenetic-proteins-in-pediatric-spinal-arthrodesis-a-statewide-analysis-of-trends-and-outcome-of-utilization
#8
Benedict U Nwachukwu, William W Schairer, Ting Pan, Roger F Widmann, John S Blanco, Daniel W Green, Stephen Lyman, Emily R Dodwell
INTRODUCTION: Bone morphogenetic protein (BMP) is considered off-label when used to augment spinal arthrodesis in children and adolescents. There is a paucity of longer-term information on BMP use in this population. The purpose of this study was to determine the rate of BMP utilization in pediatric spinal arthrodesis, assess factors associated with BMP use in this population, and evaluate long-term outcome. METHODS: Spinal arthrodeses in patients 18 years and younger performed in New York State between 2004 and 2014 were identified through the Statewide Planning and Research Cooperative System database...
January 5, 2017: Journal of Pediatric Orthopedics
https://www.readbyqxmd.com/read/28058986/midterm-results-of-proximal-aneurysm-sealing-with-the-ovation-stent-graft-according-to-on-vs-off-label-use
#9
Gianmarco de Donato, Francesco Setacci, Luciano Bresadola, Patrizio Castelli, Roberto Chiesa, Nicola Mangialardi, Giovanni Nano, Carlo Setacci
PURPOSE: To compare the use of the Ovation stent-graft according to the ≥7-mm neck length specified by the original instructions for use (IFU) vs those treated off-label (OL) for necks <7 mm long. METHODS: A multicenter retrospective registry (TriVascular Ovation Italian Study) database of all patients who underwent endovascular aneurysm repair with the Ovation endograft at 13 centers in Italy was interrogated to identify patients with a minimum computed tomography (CT) follow-up of 24 months, retrieving records on 89 patients (mean age 76...
January 1, 2017: Journal of Endovascular Therapy
https://www.readbyqxmd.com/read/28057952/direct-thrombin-inhibitor-resistance-and-possible-mechanisms
#10
Maria Cardinale, Michael Ha, Michael H Liu, David P Reardon
Objective: To report 3 cases in which doses of bivalirudin higher than commonly used in clinical practice were required in order to achieve therapeutic anticoagulation as monitored by the activated partial thromboplastin time (aPTT). Case Summary: The medical records of 3 patients who required large doses of bivalirudin to remain therapeutic were thoroughly reviewed. In all 3 patients, bivalirudin was initiated at a rate appropriate for the patients' renal function and titrated using a nurse-driven protocol with recommended dose adjustments based on aPTT...
December 2016: Hospital Pharmacy
https://www.readbyqxmd.com/read/28057947/pentostatin-cyclophosphamide-and-rituximab-pcr-regimen
#11
Dominic A Solimando, J Aubrey Waddell
The complexity of cancer chemotherapy requires pharmacists be familiar with the complicated regimens and highly toxic agents used. This column reviews various issues related to preparation, dispensing, and administration of antineoplastic therapy, and the agents, both commercially available and investigational, used to treat malignant diseases. Questions or suggestions for topics should be addressed to Dominic A. Solimando, Jr., President, Oncology Pharmacy Services, Inc., 4201 Wilson Blvd #110-545, Arlington, VA 22203, email: OncRxSvc@comcast...
December 2016: Hospital Pharmacy
https://www.readbyqxmd.com/read/28057286/transcatheter-valve-in-ring-implantation%C3%A2-for-the-treatment-of-residual%C3%A2-or-recurrent-tricuspid-valve-dysfunction-after-prior-surgical-repair
#12
Jamil Aboulhosn, Allison K Cabalka, Daniel S Levi, Dominique Himbert, Luca Testa, Azeem Latib, Raj R Makkar, Younes Boudjemline, Dennis W Kim, Joelle Kefer, Sabine Bleiziffer, Gunter Kerst, Danny Dvir, Doff B McElhinney
OBJECTIVES: This study sought to describe the results of transcatheter tricuspid valve-in-ring (TVIR) implantation for treatment of tricuspid regurgitation (TR). BACKGROUND: Off-label use of transcatheter valves within surgically placed tricuspid annuloplasty prostheses has only been described in small reports. An international multicenter registry was developed to collect data on TVIR implantation. METHODS: Data were collected from 13 sites on 22 patients (5 to 69 years of age) with TR who underwent catheterization with the intent to perform TVIR implantation...
January 9, 2017: JACC. Cardiovascular Interventions
https://www.readbyqxmd.com/read/28056550/co-inhalation-of-roflumilast-rather-than-formoterol-with-fluticasone-more-effectively-improves-asthma-in-asthmatic-mice
#13
Hussam A Murad, Hamed S Habib, Misbahuddin M Rafeeq, Mansour I Sulaiman, Amer S Abdulrahman, Mohamad Nidal Khabaz
Roflumilast is approved as an add-on therapy for chronic obstructive pulmonary disease. The inflammation in chronic obstructive pulmonary disease is mainly neutrophilic, while in asthma it is mainly eosinophilic, studies addressing role of roflumilast in eosinophilic inflammation are recommended. Also in severe asthma, the dominant inflammatory cells are neutrophils. Thus, roflumilast has a potential off-label use in the treatment of asthma. This study was designed to evaluate the effects of co-inhalation of roflumilast and fluticasone compared to that of formoterol and fluticasone in ovalbumin-sensitized and-challenged BALB/c mice...
January 1, 2017: Experimental Biology and Medicine
https://www.readbyqxmd.com/read/28055126/neuromodulation-therapies-for-alcohol-addiction-a-literature-review
#14
REVIEW
Celeste A Azevedo, Antonios Mammis
OBJECTIVES: The goal of this review is to explore alternative neurological therapies in the treatment of alcohol use disorder; including transcranial direct current stimulation (tDCS), transcranial magnetic stimulation, deep brain stimulation (DBS), electroconvulsive therapy (ECT), and the off-label use of the GABAB receptor agonist baclofen. METHODS: A comprehensive literature search was conducted through EBSCOhost regarding the neurological therapies in the treatment of alcoholism discussed in this paper...
January 5, 2017: Neuromodulation: Journal of the International Neuromodulation Society
https://www.readbyqxmd.com/read/28051241/effects-of-omalizumab-therapy-on-allergic-rhinitis-a-pilot-study
#15
S Masieri, C Cavaliere, E Begvarfaj, D Rosati, A Minni
OBJECTIVE: The use of omalizumab, a humanized monoclonal antibody able to binding Ig-E, is currently authorized only for treatment of severe bronchial asthma. The use of omalizumab in other Ig-E related diseases is off-label, although some studies have provided promising results about it. The aim of this study was to evaluate if therapy with omalizumab in patients affected by asthma and allergic rhinitis has an impact also on allergic rhinitis-related symptoms. PATIENTS AND METHODS: A longitudinal study was conducted on 11 patients affected by severe asthma and a periodic allergic rhinitis...
December 2016: European Review for Medical and Pharmacological Sciences
https://www.readbyqxmd.com/read/28042127/longterm-beneficial-effect-of-canakinumab-in-colchicine-resistant-familial-mediterranean-fever
#16
Katerina Laskari, Panagiota Boura, George N Dalekos, Alexandros Garyfallos, Dimitrios Karokis, Dimitrios Pikazis, Loukas Settas, Grigoris Skarantavos, Elena Tsitsami, Petros P Sfikakis
OBJECTIVE: To assess the efficacy and safety of the interleukin-1β (IL-1β) inhibitor canakinumab in all adolescent and adult patients with familial Mediterranean fever (FMF) identified from the Greek National Registry for off-label drug use between 2010 and 2015. METHODS: In this retrospective longitudinal outcome study, clinical and laboratory data were collected from 14 patients (7 men) aged median 38.5 years (range 13-70), with median disease duration of 14 years, and active FMF despite colchicine (n = 9) or both colchicine and anakinra (n = 5)...
January 2017: Journal of Rheumatology
https://www.readbyqxmd.com/read/28041968/medicines-for-pediatric-patients-biopharmaceutical-developmental-and-regulatory-considerations
#17
David P Elder, René Holm, Martin Kuentz
This commentary reflects current developments in pediatric medicine. The underpinning legislation in both Europe and the US has led to the initiation of an increased number of clinical trials in the pediatric population, but there are still a number of outstanding issues within this field. These include the differences in the physiology between adults and the very heterogeneous nature of pediatric patients. There is an ongoing scientific debate on the applicability of a Pediatric Biopharmaceutical Classification System (PBCS) to define when waivers for bioequivalence studies can be supported by in vitro dissolution...
December 29, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28040715/prolonged-response-to-her2-directed-therapy-in-a-patient-with-her2-amplified-rapidly-progressive-metastatic-colorectal-cancer
#18
Aparna Parikh, Chloe Atreya, W Michael Korn, Alan P Venook
HER2 gene amplifications and activating mutations in the HER2 receptor tyrosine kinase are present in 4% of metastatic colorectal cancers (mCRCs). HER2-targeted therapy is not standard of care, although preclinical and clinical data suggest that patients with HER2 amplifications and/or HER2-activating mutations may benefit from HER2-directed therapy. HER2 amplifications and activating mutations have also been implicated in resistance to anti-epidermal growth factor receptor-based therapy. This report describes a patient with KRAS, NRAS, and BRAF wild-type mCRC who experienced disease progression on first-line treatment with FOLFIRI and cetuximab after only 5 months, and subsequently experienced progression on second-line treatment with capecitabine and oxaliplatin plus bevacizumab after 2 months with significant functional decline...
January 2017: Journal of the National Comprehensive Cancer Network: JNCCN
https://www.readbyqxmd.com/read/28029187/off-label-uses-for-flow-diversion-in-intracranial-aneurysm-management
#19
Fawaz Al-Mufti, Krishna Amuluru, Gomez Francisco, Vincent Dodson, Mohammad El-Ghanem, Charles J Prestigiacomo, Chirag D Gandhi
Treatment of complex aneurysms using microsurgical and other conventional neuroendovascular techniques remains challenging. As a result, stent- and balloon-assisted coiling are instead performed to treat morphologically complex aneurysms, which include giant, wide-necked, and fusiform aneurysms. While these techniques have had success in treating these complex aneurysms, recanalization rates associated with these techniques are still problematic. In the constant effort to improve the outcome of complex aneurysm treatment, flow-diverting stents (FDSs) have emerged in recent years as the preferred treatment...
December 28, 2016: Journal of Neuroimaging: Official Journal of the American Society of Neuroimaging
https://www.readbyqxmd.com/read/28028813/accuracy-of-tablet-splitting-and-liquid-measurements-an-examination-of-who-what-and-how
#20
Dana Abu-Geras, Dunja Hadziomerovic, Andrew Leau, Ramzan Nazim Khan, Sajni Gudka, Cornelia Locher, Maryam Razaghikashani, Lee Yong Lim
OBJECTIVE: To examine factors that might affect the ability of patients to accurately halve tablets or measure a 5-ml liquid dose. METHODS: Eighty-eight participants split four different placebo tablets by hand and using a tablet splitter, while 85 participants measured 5 ml of water, 0.5% methylcellulose (MC) and 1% MC using a syringe and dosing cup. Accuracy of manipulation was determined by mass measurements. KEY FINDINGS: The general population was less able than pharmacy students to break tablets into equal parts, although age, gender and prior experience were insignificant factors...
December 28, 2016: Journal of Pharmacy and Pharmacology
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