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Neha N Pardeshi, Wei Qi, Kevin Dahl, Liron Caplan, John F Carpenter
Intravenous (IV) infusion is used for administration of a large proportion of biologic therapeutics, including most monoclonal antibody products. In this study, we determined the subvisible particle levels in IV solutions and after the solutions were processed with an IV administration setup that mimicked the typical clinical method of administration. IV saline in bags manufactured by both Hospira and Baxter contained 1600-8000 microparticles/mL and 4-73 × 10(6) nanoparticles/mL in solution. When IV immunoglobulin was diluted into the IV saline, 3700-23,000 microparticles/mL and 18-240 × 10(6) nanoparticles/mL were detected...
February 2017: Journal of Pharmaceutical Sciences
Stefan Fruehauf, Burkhard Otremba, Oliver Stötzer, Christine Rudolph
INTRODUCTION: Febrile neutropenia (FN) is a serious and frequent complication of cytotoxic chemotherapy. Biosimilar filgrastim (Nivestim™, Hospira Inc, A Pfizer Company, Lake Forest, IL, USA) is a granulocyte-colony stimulating factor licensed for the treatment of neutropenia and FN induced by myelosuppressive chemotherapy. The primary goal of this VENICE study ( identifier, NCT01627990) was to observe the tolerability, safety and efficacy of biosimilar filgrastim in patients receiving cancer chemotherapy...
November 2016: Advances in Therapy
Nour Al Faqeer, Ola Mashni, Rawan Dawoud, Asma Rumman, Esraa Hanoun, Lama Nazer
Studies have raised concern about the safety of generic compared with branded drugs. Febrile neutropenia (FN) resulting in hospital admission was compared between the branded docetaxel (Taxotere®, Sanofi) and 2 generic formulations (docetaxel Ebewe and docetaxel Hospira) in patients with breast cancer. This was a retrospective study that included patients with breast cancer who received docetaxel between January 2012 and December 2014. Patients who had an admission diagnosis of FN and had received docetaxel within 14 days prior to admission were evaluated...
February 2017: Journal of Clinical Pharmacology
Dennis Stalker, Susan Reid, Atulkumar Ramaiya, Wayne A Wisemandle, Nancy E Martin
PURPOSE: The purpose of this study was to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of single 100 U/kg subcutaneous doses of Epoetin Hospira and Epogen in healthy male subjects as part of an overall program to demonstrate biosimilarity of Epoetin Hospira to the reference product Epogen. METHODS: This single-center, open-label, randomized, 2-period, crossover study was conducted in 81 healthy male subjects. Subjects were randomized to Sequence 1, in which they received 100 U/kg of Epoetin Hospira or to sequence 2, in which they received 100 U/kg Epogen subcutaneously in the first study period and the alternative treatment in the second study period...
August 2016: Clinical Therapeutics
Theodor Dingermann, Florian Scotte
INTRODUCTION: There is an essential need for clinicians to understand the development and approval process of biosimilars. Extrapolation of efficacy and safety data from one indication to another may be considered by a comprehensive comparability program including safety, efficacy and immunogenicity, which detect potentially clinically relevant differences. AREAS COVERED: This article specifically discusses the approval of epoetin zeta (Retacrit™, Hospira, a Pfizer company) and the EMA reasoning for extrapolation of indications...
July 2016: Expert Opinion on Biological Therapy
Dennis Stalker, Atulkumar Ramaiya, Seema Kumbhat, Jeffrey Zhang, Susan Reid, Nancy Martin
PURPOSE: The purpose of this study was to evaluate the pharmacodynamic (PD) and pharmacokinetic (PK) equivalences of multiple doses of the proposed biosimilar Epoetin Hospira to the reference product Epogen(⁎), when each is administered three times per week over 28 days to healthy male subjects METHODS: This single center, open-label, randomized, parallel group study was conducted in 129 healthy male subjects. Subjects were randomized to receive 100 U/kg Epoetin Hospira or 100 U/kg Epogen, each administered subcutaneously 3 times per week over 28 days...
2016: Clinical Therapeutics
Gayathri Kumarasinghe, Ling Gao, Mark Hicks, Jeanette Villanueva, Aoife Doyle, Padmashree Rao, Min Ru Qiu, Andrew Jabbour, Arjun Iyer, Hong Chee Chew, Christopher S Hayward, Peter Macdonald
BACKGROUND: Hearts from older donors are increasingly being referred for transplantation. However, these hearts are more susceptible to ischemia-reperfusion injury (IRI), reflected in higher rates of primary graft dysfunction. We assessed a strategy of pharmacologic conditioning, supplementing Celsior (Genzyme, Naarden, The Netherlands) preservation solution with glyceryl trinitrate (GTN; Hospira Australia Pty, Ltd, Mulgrave, VIC, Australia), erythropoietin (EPO; Eprex; Janssen-Cilag, North Ryde, NSW, Australia), and zoniporide (ZON; Pfizer, Inc...
May 2016: Journal of Heart and Lung Transplantation
Cristina Tomasello, Anna Leggieri, Roberta Cavalli, Giovanni Di Perri, Antonio D'Avolio
BACKGROUND: Meropenem is a beta-lactam antibiotic for treating multidrug-resistant gram-negative bacilli infections. The expiry of the drug's patent (Merrem) allowed the production of generics to be commercialized by a few companies, including Hospira and Hikma. The stability of these medicines after reconstitution as reported on a data sheet report is 6 hours for Merrem and 1 hour for generics. OBJECTIVES: The aim of this work was to evaluate the stability profile of 3 products in 0...
April 2015: Hospital Pharmacy
Jesse D Sutton, Ryan P Mynatt, Keith S Kaye, Kyle P Murray, Michael J Rybak, Jason M Pogue
To date, no comparative clinical studies have investigated the effects of different vancomycin products on nephrotoxicity. The objective of this single-center, retrospective, matched-cohort study was to investigate the impact of two different vancomycin products on the development of nephrotoxicity. The study population included adults receiving a single vancomycin product, from either Pfizer or Hospira, for their entire course of therapy. Patients were matched based on underlying nephrotoxicity risk factors...
September 2015: Antimicrobial Agents and Chemotherapy
Jürgen Braun, Alex Kudrin
Biosimilars are biologic medical products whose active drug substance is made by a living organism or derived from it. The term is used to describe a subsequent version of an innovator biopharmaceutical product aiming at approval following patent expiry on the reference product. Biosimilars of monoclonal need to demonstrate similar but not identical quality of nonclinical and clinical attributes. Not all data of the originator product need to be recapitulated, as large numbers of patient-years of exposure data are already available...
2015: Immunotherapy
J Dewulf, L Galanti, M Godet, P Gillet, J Jamart, J-D Hecq
INTRODUCTION: The aim of the study was to investigate the long-term stability of acyclovir 5 mg/mL (a generic product versus the brand name) in NaCl 0.9% after storage at 5±3°C and to evaluate the influence of initial freezing and microwave thawing on this stability. METHODS: Five bags of Acyclovir® Hospira 5 mg/mL (A) and five bags of Zovirax® GSK 5 mg/mL (B) were prepared under aseptic conditions and stored 3 months at -20°C, then thawed and stored 30 days at 4°C...
March 2015: Annales Pharmaceutiques Françaises
C Gómez-Baraza, M J Agustín-Fernández, P I Palomo-Jiménez, J M Real-Campaña, R Abad-Sazatornil
OBJECTIVE: To analyze the role of smart infusion pumps in reducing errors related with the administration of intravenous medications. METHOD: Retrospective, observational study analyzing the implementation of a system with smart intravenous infusion pumps (Hospira MedNetTM) and the role of the safety system for the detection of errors during the administration of drugs, sera, and blood. We included infusions administered at the day-care hospitals of hematology, oncology, rheumatology, and oncopediatrics...
July 2014: Farmacia Hospitalaria
James Bell, Lindell K Weaver, Kayla Deru
BACKGROUND: We evaluated the Hospira Plum A+ (HB) hyperbaric infusion pump under monoplace and multiplace hyperbaric conditions to test pump flow accuracy. METHODS: Pump flow accuracy was tested in monoplace and multiplace hyperbaric chambers at different rates, fluid viscosities, pressures and volumes. Output was recorded from the pump (programmed) and from graduated cylinders or syringes (actual). The lead acid battery life was recorded for multiplace trials. RESULTS: In monoplace trials to 3...
May 2014: Undersea & Hyperbaric Medicine: Journal of the Undersea and Hyperbaric Medical Society, Inc
Paul O Lewis, Loren M Kirk, Stacy D Brown
PURPOSE: Three different generic vancomycin products were compared using liquid chromatography-mass spectrometry (LC-MS) and open-access metabolomic tools. METHODS: Single-lot samples of vancomycin hydrochloride from three different manufacturers (Hospira, APP Pharmaceuticals, and Pfizer) were reconstituted and injected into a high-resolution LC-MS system. The mass spectral fingerprints were compared for similarity of nonvancomycin B components using the XCMS Online system through Scripps University...
June 15, 2014: American Journal of Health-system Pharmacy: AJHP
Kristin A Otting, Kayla R Stover, John D Cleary
Several studies have demonstrated that piperacillin/tazobactam produces a false-positive result for the galactomannan antigen test. However, the most recent literature has demonstrated that this interaction is no longer a concern. There is little information regarding the drug-laboratory interaction with the generics of piperacillin/tazobactam or other broad-spectrum beta-lactams, such as ceftaroline, doripenem, imipenem/cilastatin, and meropenem. The purpose of this study was to determine if a drug-laboratory interaction exists with these antibiotics...
September 2014: Brazilian Journal of Infectious Diseases
Loretta Franceschi, Piergiorgio Cojutti, Massimo Baraldo, Federico Pea
Administration by continuous infusion may represent an effective tool for the treatment of multidrug-resistant gram-negative related infections with meropenem. Currently, no data on chemical stability of generic bioequivalent versions of meropenem over time are available. Triplicate samples of 5 mg/mL solutions of a generic meropenem formulation, Hospira, were evaluated for chemical stability at increasing temperatures (25°C, 30°C, 35°C, and 40°C) by means of a high-performance liquid chromatography technique over 4 separate days...
October 2014: Therapeutic Drug Monitoring
H L Diaz, S K R Karnati, M A Lyons, B A Dehority, J L Firkins
In contrast to the well-characterized chemotaxis and migratory behavior between the dorsal and ventral locations of the rumen by isotrichids, we hypothesized that chemotaxis toward soluble nutrients maintains entodiniomorphid protozoa in the particulate fraction. The objectives of these experiments were to compare the dose-responsive chemotaxis (1) toward different glucose concentrations when ruminal samples were harvested from fed versus fasted cows; (2) toward increasing concentrations of glucose compared with xylose when protozoa were harvested from a fed cow; (3) toward peptides of bacterial, protozoal, and soy origin; and (4) toward glucose when mixed ruminal protozoa were previously incubated for 0, 3, or 6h in the presence of emulsified polyunsaturated fatty acids (PUFA; Liposyn II, Hospira, Lake Forest, IL)...
2014: Journal of Dairy Science
Silvia Manrique-Rodríguez, Amelia C Sánchez-Galindo, Ana de Lorenzo-Pinto, Leticia González-Vives, Jesús López-Herce, Ángel Carrillo-Álvarez, María Sanjurjo-Sáez, Cecilia M Fernández-Llamazares
Patient safety is a matter of major concern that involves every health professional. Nowadays, emerging technologies such as smart pumps can diminish medication errors as well as standardise and improve clinical practice with the subsequent benefits for patients. The aim of this paper was to describe the smart pump implementation process in a paediatric intensive care unit (PICU) and to present the most relevant infusion-related programming errors that were prevented. This was a comparative study between CareFusion Alaris Guardrails(®) and Hospira MedNet(®) systems, as well as a prospective and intervention study with analytical components carried out in the PICU of Gregorio Marañón General and Teaching Hospital...
September 2015: Health Informatics Journal
Elaine Harris
The present industry update covers the period September 2013, with information sourced predominantly from company press releases, regulatory and patent agencies. This month saw approvals for a number of products employing drug-delivery technologies including Purdue's new 15 mcg/h dosage strength of Butrans(®) and Medtronics first generation artificial pancreas device system with Threshold Suspend automation. The first European approval was also achieved for a biosimilar monoclonal antibody product, Hospira's Inflectra™ (infliximab)...
December 2013: Therapeutic Delivery
Didier Kamioner, Stefan Fruehauf, Fréderic Maloisel, Laurent Cals, Stéphane Lepretre, Christian Berthou
BACKGROUND: Nivestim™ (filgrastim) is a follow-on biologic agent licensed in the EU for the treatment of neutropenia and febrile neutropenia induced by myelosuppressive chemotherapy. Nivestim™ has been studied in phase 2 and 3 clinical trials where its efficacy and safety was found to be similar to its reference product, Neupogen®. Follow-on biologics continue to be scrutinised for safety. We present a design for two observational phase IV studies that are evaluating the safety profile of Nivestim™ for the prevention and treatment of febrile neutropenia (FN) in patients treated with cytotoxic chemotherapy in general clinical practice...
November 16, 2013: BMC Cancer
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